Ellipse™

CompletedPhase 3Results posted

Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

185

Recruiting sites

—

Enrollment

135

actual

Study population

Type 2 diabetes

Key I/E criteria

•HbA1c 7-11%•Age 10-17

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01541215

Org study IDNN2211-3659

Secondary ID2011-002605-29

Secondary IDCTRI/2013/10/004082Clinical Trials Registry - India (CTRI)

Secondary IDP/288/2010EMA (PDCO)

Secondary IDU1111-1121-8743WHO

Timeline

Milestones

Study first posted2012-02-29estimated

Study start2012-11-13actual

Primary completion2017-11-15actual

Results first posted2018-12-11actual

Study completion2020-05-20actual

Last update posted2021-07-02actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age10 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population Exclusion Criteria: - Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics

Endpoints (160)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Cardiometabolic biomarkers

Other clinical outcomes

Weight & body composition

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

21 endpoints

Secondary/registry result

Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)

Time frame:Week 0, week 26

BMI SDS, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), SDS score	95% CI
Liraglutide 1.8 mg	-0.254	—
Placebo	-0.208	—

Treatment difference-0.04795% CI-0.153 – 0.060p0.392Pattern Mixture Model

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide 1.8 mg	-2.48	—
Placebo	-0.87	—

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide 1.8 mg	-2.27	—
Placebo	1.02	—

Secondary/registry result

Change From Baseline in BMI Standard Deviation Score (SDS)

Time frame:Week 0, week 52

BMI SDS, change

change from baseline, improvement

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg	-0.361	—
Placebo	-0.166	—

Secondary/registry result

Change From Baseline in Height SDS

Time frame:Week 0, week 26

change from baseline, improvement

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg	-0.100	—
Placebo	-0.042	—

Secondary/registry result

Change From Baseline in Height SDS

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg	-0.192	—
Placebo	-0.134	—

Secondary/registry result/low confidence

Height Velocity SDS

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg	-1.24	—
Placebo	-0.557	—

Secondary/registry result/low confidence

Height Velocity SDS

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg	-0.887	—
Placebo	-0.551	—

Secondary/registry result

Change From Week 52 in Height SDS- Week 104

Time frame:Week 52, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg: Follow-up 1	-0.133	—

Secondary/registry result/low confidence

Change From Week 52 in Height SDS- Week 156

Time frame:Week 52, week 156

change from baseline, descriptive

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg: Follow-up 1 and 2	-0.224	—

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)

Time frame:Week 0, week 26

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0, week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Week 0, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in BMI Standard Deviation Score (SDS)

Time frame:Week 0, week 52

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Height SDS

Time frame:Week 0, week 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Height SDS

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint

Height Velocity SDS

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Height Velocity SDS

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Height Velocity SDS- Week 104

Time frame:Week 0, week 104

change from baseline, improvement

Secondary/protocol endpoint

Change From Week 52 in Height SDS- Week 104

Time frame:Week 52, week 104

change from baseline, improvement

Secondary/protocol endpoint

Change From Week 52 in Height SDS- Week 156

Time frame:Week 52, week 156

change from baseline, improvement

Glycemic / diabetes

62 endpoints

Primary/registry result

Change in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of HbA1c	95% CI
Liraglutide 1.8 mg	-0.643	—
Placebo	0.415	—

Treatment difference-1.05895% CI-1.653 – -0.464p<0.001Pattern Mixture Model

Primary/protocol endpoint

Change in HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Liraglutide 1.8 mg	-1.076	—
Placebo	0.801	—

Treatment difference-1.87895% CI-3.093 – -0.662p0.002Pattern Mixture Model

Secondary/registry result

Number of Subjects Having HbA1c Below 7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of subjects	95% CI
Liraglutide 1.8 mg	63.7	—
Placebo	36.5	—

Treatment odds ratio5.35395% CI2.105 – 13.615p<0.001logistic regression model

Secondary/registry result

Number of Subjects Having HbA1c Below 7.0%

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mgYes	27	—
No	29	—
PlaceboYes	16	—
No	36	—

Secondary/registry result

Number of Subjects Having HbA1c Maximum 6.5%

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mgYes	28	—
No	31	—
PlaceboYes	19	—
No	39	—

Secondary/registry result

Number of Subjects Having HbA1c Maximum 6.5%

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mgYes	25	—
No	31	—
PlaceboYes	13	—
No	39	—

Secondary/registry result

Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mgYes	31	—
No	28	—
PlaceboYes	21	—
No	37	—

Secondary/registry result

Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mgYes	22	—
No	34	—
PlaceboYes	16	—
No	36	—

Secondary/registry result

Number of Subjects Having HbA1c Below 7.5%

Time frame:Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mgYes	43	—
No	16	—
PlaceboYes	29	—
No	29	—

Secondary/registry result

Number of Subjects Having HbA1c Below 7.5%

Time frame:Week 52

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mgYes	36	—
No	20	—
PlaceboYes	23	—
No	29	—

Secondary/registry result

Change in HbA1c

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of HbA1c	95% CI
Liraglutide 1.8 mg	-0.732	—
Placebo	0.677	—

Secondary/registry result

Change in FPG

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 1.8 mg	-1.627	—
Placebo	0.983	—

Secondary/registry result

Change in Mean 7-point Self-measured Plasma Glucose

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 1.8 mg	-2.384	—
Placebo	0.198	—

Secondary/registry result

Change From Baseline in 7-point Self-measured Plasma Glucose

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 1.8 mg	-2.309	—
Placebo	-0.748	—

Secondary/registry result

Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 1.8 mgBreakfast	-1.528	—
Lunch	-0.358	—
Dinner	0.397	—
PlaceboBreakfast	-0.319	—
Lunch	-0.658	—
Dinner	-0.226	—

Secondary/registry result

Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 1.8 mgBreakfast	-1.802	—
Lunch	-0.735	—
Dinner	-0.028	—
PlaceboBreakfast	0.053	—
Lunch	-1.219	—
Dinner	-0.195	—

Secondary/registry result

Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 1.8 mg	-0.428	—
Placebo	-0.362	—

Secondary/registry result

Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 1.8 mg	-0.747	—
Placebo	-0.397	—

Secondary/registry result

Ratio to Baseline: Fasting Insulin

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.9	—
Placebo	1.0	—

Secondary/registry result

Ratio to Baseline: Fasting Insulin

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	1.0	—
Placebo	1.1	—

Secondary/registry result/low confidence

Ratio to Baseline: Fasting Pro-insulin

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.62	—
Placebo	0.88	—

Secondary/registry result/low confidence

Ratio to Baseline: Fasting Pro-insulin

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.62	—
Placebo	0.79	—

Secondary/registry result/low confidence

Ratio to Baseline: Pro-insulin/Insulin Ratio

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.690	—
Placebo	0.923	—

Secondary/registry result/low confidence

Ratio to Baseline: Pro-insulin/Insulin Ratio

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.689	—
Placebo	0.770	—

Secondary/registry result

Ratio to Baseline: Fasting Glucagon

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.98	—
Placebo	1.03	—

Secondary/registry result

Ratio to Baseline: Fasting Glucagon

Time frame:Week 0, week 52

fasting glucagon ratio baseline

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	1.01	—
Placebo	1.05	—

Secondary/registry result

Ratio to Baseline: Fasting C-peptide

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.93	—
Placebo	0.84	—

Secondary/registry result

Ratio to Baseline: Fasting C-peptide

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.94	—
Placebo	0.83	—

Secondary/registry result

Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

Time frame:Week 0, week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	1.24	—
Placebo	1.01	—

Secondary/registry result/low confidence

Ratio to Baseline: HOMA-B

Time frame:Week 0, week 52

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	1.48	—
Placebo	0.93	—

Secondary/registry result

Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

Time frame:Week 0, week 26

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.73	—
Placebo	0.98	—

Secondary/registry result

Ratio to Baseline: HOMA-IR

Time frame:Week 0, week 52

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.82	—
Placebo	1.08	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Number of Subjects Having HbA1c Below 7.0%

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Subjects Having HbA1c Below 7.0%

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Subjects Having HbA1c Maximum 6.5%

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Subjects Having HbA1c Maximum 6.5%

Time frame:Week 52

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes

Time frame:Week 52

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Number of Subjects Having HbA1c Below 7.5%

Time frame:Week 26

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Subjects Having HbA1c Below 7.5%

Time frame:Week 52

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:Week 0, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Mean 7-point Self-measured Plasma Glucose

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 7-point Self-measured Plasma Glucose

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)

Time frame:Week 0, week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)

Time frame:Week 0, week 52

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Ratio to Baseline: Fasting Insulin

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: Fasting Insulin

Time frame:Week 0, week 52

ratio, improvement

Secondary/protocol endpoint/low confidence

Ratio to Baseline: Fasting Pro-insulin

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint/low confidence

Ratio to Baseline: Fasting Pro-insulin

Time frame:Week 0, week 52

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: Pro-insulin/Insulin Ratio

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: Pro-insulin/Insulin Ratio

Time frame:Week 0, week 52

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: Fasting C-peptide

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: Fasting C-peptide

Time frame:Week 0, week 52

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: HOMA-B

Time frame:Week 0, week 52

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)

Time frame:Week 0, week 26

HOMA-IR (insulin sensitivity)

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: HOMA-IR

Time frame:Week 0, week 52

HOMA-IR (insulin sensitivity)

ratio, improvement

Cardiometabolic biomarkers

32 endpoints

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 26

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide 1.8 mgSystolic Blood Pressure	-1.65	—
Diastolic Blood Pressure	-1.27	—
PlaceboSystolic Blood Pressure	0.03	—
Diastolic Blood Pressure	0.97	—

Secondary/registry result

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 52

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide 1.8 mgSystolic Blood Pressure	-0.77	—
Diastolic Blood Pressure	0.46	—
PlaceboSystolic Blood Pressure	2.81	—
Diastolic Blood Pressure	1.83	—

Secondary/registry result

Ratio to Baseline: Total Cholesterol

Time frame:Week 0, week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.975	—
Placebo	1.008	—

Secondary/registry result

Ratio to Baseline: Total Cholesterol

Time frame:Week 0, week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	1.013	—
Placebo	1.026	—

Secondary/registry result

Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol

Time frame:Week 0, week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.998	—
Placebo	0.993	—

Secondary/registry result

Ratio to Baseline: LDL Cholesterol

Time frame:Week 0, week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	1.042	—
Placebo	1.035	—

Secondary/registry result

Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol

Time frame:Week 0, week 26

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.890	—
Placebo	1.035	—

Secondary/registry result

Ratio to Baseline: VLDL Cholesterol

Time frame:Week 0, week 52

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.983	—
Placebo	1.003	—

Secondary/registry result

Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol

Time frame:Week 0, week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.997	—
Placebo	0.981	—

Secondary/registry result

Ratio to Baseline: HDL Cholesterol

Time frame:Week 0, week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	1.028	—
Placebo	1.000	—

Secondary/registry result

Ratio to Baseline: Triglycerides

Time frame:Week 0, week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.894	—
Placebo	1.038	—

Secondary/registry result

Ratio to Baseline: Triglycerides

Time frame:Week 0, week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.964	—
Placebo	1.036	—

Secondary/registry result

Ratio to Baseline: Free Fatty Acids

Time frame:Week 0, week 26

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	1.023	—
Placebo	0.985	—

Secondary/registry result

Ratio to Baseline: Free Fatty Acids

Time frame:Week 0, week 52

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), ratio	95% CI
Liraglutide 1.8 mg	0.928	—
Placebo	0.868	—

Secondary/registry result

Change From Baseline in Pulse

Time frame:Week 0, week 26

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/minute	95% CI
Liraglutide 1.8 mg	1.40	—
Placebo	0.33	—

Secondary/registry result

Change From Baseline in Pulse

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/minute	95% CI
Liraglutide 1.8 mg	-0.05	—
Placebo	-0.28	—

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Time frame:Week 0, week 52

change from baseline, improvement

Secondary/protocol endpoint

Ratio to Baseline: Total Cholesterol

Time frame:Week 0, week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to Baseline: Total Cholesterol

Time frame:Week 0, week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol

Time frame:Week 0, week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to Baseline: LDL Cholesterol

Time frame:Week 0, week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol

Time frame:Week 0, week 26

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: VLDL Cholesterol

Time frame:Week 0, week 52

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol

Time frame:Week 0, week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to Baseline: HDL Cholesterol

Time frame:Week 0, week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to Baseline: Triglycerides

Time frame:Week 0, week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to Baseline: Triglycerides

Time frame:Week 0, week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to Baseline: Free Fatty Acids

Time frame:Week 0, week 26

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Ratio to Baseline: Free Fatty Acids

Time frame:Week 0, week 52

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Pulse

Time frame:Week 0, week 26

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Pulse

Time frame:Week 0, week 52

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

20 endpoints

Secondary/registry result

Number of Hypoglycaemic Episodes

Time frame:0-26 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), hypoglycaemic episodes	95% CI
Liraglutide 1.8 mg	92	—
Placebo	43	—

Secondary/registry result

Number of Hypoglycaemic Episodes

Time frame:0-52 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), hypoglycaemic episodes	95% CI
Liraglutide 1.8 mg	160	—
Placebo	63	—

Secondary/registry result

Number of Adverse Events (Week 0-26)

Time frame:0-26 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 1.8 mg	310	—
Placebo	230	—

Secondary/registry result

Number of Adverse Events (Week 0-52)

Time frame:0-52 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 1.8 mg	426	—
Placebo	321	—

Secondary/registry result

Number of Serious Adverse Events (Week 0-26)

Time frame:0-26 weeks

Serious AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 1.8 mg	7	—
Placebo	4	—

Secondary/registry result

Number of Serious Adverse Events (Week 0-52)

Time frame:0-52 weeks

Serious AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 1.8 mg	10	—
Placebo	5	—

Secondary/registry result

Number of Adverse Events (Week 53-104)

Time frame:Week 53-104

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 1.8 mg: Follow-up 1	30	—

Secondary/registry result

Number of Serious Adverse Events (Week 53-104)

Time frame:Weeks 53-104

Serious AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 1.8 mg: Follow-up 1	7	—

Secondary/registry result

Number of Adverse Events (Week 53-156)

Time frame:Week 53-156

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 1.8 mg: Follow-up 1 and 2	47	—

Secondary/registry result

Number of Serious Adverse Events (Week 53-156)

Time frame:Weeks 53-156

Serious AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 1.8 mg: Follow-up 1 and 2	9	—

Secondary/protocol endpoint

Number of Hypoglycaemic Episodes

Time frame:0-26 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Hypoglycaemic Episodes

Time frame:0-52 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Adverse Events (Week 0-26)

Time frame:0-26 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Adverse Events (Week 0-52)

Time frame:0-52 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (Week 0-26)

Time frame:0-26 weeks

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (Week 0-52)

Time frame:0-52 weeks

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Adverse Events (Week 53-104)

Time frame:Week 53-104

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (Week 53-104)

Time frame:Weeks 53-104

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Adverse Events (Week 53-156)

Time frame:Week 53-156

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (Week 53-156)

Time frame:Weeks 53-156

Serious AEs (any)

event count, event

Other clinical outcomes

23 endpoints

Secondary/registry result

Change in Bone Age Assessment (X-ray of Left Hand and Wrist)

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), years	95% CI
Liraglutide 1.8 mg	1.197	—
Placebo	1.088	—

Secondary/registry result

Pubertal Assessment/Progression (Tanner Staging)

Time frame:Week 0, week 26, week 52

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mgFemale - Breast development - Week 0	1	—
Female - Breast development - Week 0	2	—
Female - Breast development - Week 0	4	—
Female - Breast development - Week 0	8	—
Female - Breast development - Week 0	26	—
Female - Breast development - Week 26	0	—
Female - Breast development - Week 26	1	—
Female - Breast development - Week 26	2	—
Female - Breast development - Week 26	5	—
Female - Breast development - Week 26	29	—
Female - Breast development - Week 52	0	—
Female - Breast development - Week 52	0	—
Female - Breast development - Week 52	1	—
Female - Breast development - Week 52	5	—
Female - Breast development - Week 52	27	—
Male - Penis Development - Week 0	2	—
Male - Penis Development - Week 0	1	—
Male - Penis Development - Week 0	2	—
Male - Penis Development - Week 0	9	—
Male - Penis Development - Week 0	11	—
Male - Penis Development - Week 26	2	—
Male - Penis Development - Week 26	1	—
Male - Penis Development - Week 26	2	—
Male - Penis Development - Week 26	7	—
Male - Penis Development - Week 26	13	—
Male - Penis Development - Week 52	1	—
Male - Penis Development - Week 52	2	—
Male - Penis Development - Week 52	0	—
Male - Penis Development - Week 52	7	—
Male - Penis Development - Week 52	15	—
Pubic Hair Development - Week 0	3	—
Pubic Hair Development - Week 0	3	—
Pubic Hair Development - Week 0	8	—
Pubic Hair Development - Week 0	14	—
Pubic Hair Development - Week 0	38	—
Pubic Hair Development - Week 26	3	—
Pubic Hair Development - Week 26	0	—
Pubic Hair Development - Week 26	5	—
Pubic Hair Development - Week 26	11	—
Pubic Hair Development - Week 26	43	—
Pubic Hair Development - Week 52	1	—
Pubic Hair Development - Week 52	1	—
Pubic Hair Development - Week 52	4	—
Pubic Hair Development - Week 52	8	—
Pubic Hair Development - Week 52	43	—
PlaceboFemale - Breast development - Week 0	0	—
Female - Breast development - Week 0	0	—
Female - Breast development - Week 0	10	—
Female - Breast development - Week 0	9	—
Female - Breast development - Week 0	23	—
Female - Breast development - Week 26	0	—
Female - Breast development - Week 26	0	—
Female - Breast development - Week 26	4	—
Female - Breast development - Week 26	10	—
Female - Breast development - Week 26	22	—
Female - Breast development - Week 52	0	—
Female - Breast development - Week 52	0	—
Female - Breast development - Week 52	2	—
Female - Breast development - Week 52	9	—
Female - Breast development - Week 52	22	—
Male - Penis Development - Week 0	0	—
Male - Penis Development - Week 0	3	—
Male - Penis Development - Week 0	6	—
Male - Penis Development - Week 0	11	—
Male - Penis Development - Week 0	6	—
Male - Penis Development - Week 26	0	—
Male - Penis Development - Week 26	1	—
Male - Penis Development - Week 26	4	—
Male - Penis Development - Week 26	8	—
Male - Penis Development - Week 26	10	—
Male - Penis Development - Week 52	0	—
Male - Penis Development - Week 52	0	—
Male - Penis Development - Week 52	2	—
Male - Penis Development - Week 52	6	—
Male - Penis Development - Week 52	13	—
Pubic Hair Development - Week 0	3	—
Pubic Hair Development - Week 0	0	—
Pubic Hair Development - Week 0	10	—
Pubic Hair Development - Week 0	25	—
Pubic Hair Development - Week 0	29	—
Pubic Hair Development - Week 26	0	—
Pubic Hair Development - Week 26	2	—
Pubic Hair Development - Week 26	4	—
Pubic Hair Development - Week 26	18	—
Pubic Hair Development - Week 26	34	—
Pubic Hair Development - Week 52	0	—
Pubic Hair Development - Week 52	0	—
Pubic Hair Development - Week 52	2	—
Pubic Hair Development - Week 52	17	—
Pubic Hair Development - Week 52	34	—

Secondary/registry result

Growth (Height Velocity)

Time frame:Week 0, week 26

change from baseline, descriptive

Posted result

Group	Value (mean), cm/year	95% CI
Liraglutide 1.8 mg	1.633	—
Placebo	2.486	—

Secondary/registry result

Growth (Height Velocity)

Time frame:Week 0, week 52

change from baseline, descriptive

Posted result

Group	Value (mean), cm/year	95% CI
Liraglutide 1.8 mg	1.345	—
Placebo	1.817	—

Secondary/registry result

Growth (Height Velocity)- Week 104

Time frame:Week 0, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), cm/year	95% CI
Liraglutide 1.8 mg: Follow-up 1	1.149	—

Secondary/registry result

Height Velocity SDS- Week 104

Time frame:Week 0, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg: Follow-up 1	-0.523	—

Secondary/registry result

Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104

Time frame:Week 52, week 104

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mg: Follow-up 1Female- Breast development- Week 52	0	—
Female- Breast development- Week 52	0	—
Female- Breast development- Week 52	1	—
Female- Breast development- Week 52	5	—
Female- Breast development- Week 52	21	—
Female- Breast development- Week 104	0	—
Female- Breast development- Week 104	0	—
Female- Breast development- Week 104	0	—
Female- Breast development- Week 104	5	—
Female- Breast development- Week 104	11	—
Male- Penis development- Week 52	1	—
Male- Penis development- Week 52	2	—
Male- Penis development- Week 52	0	—
Male- Penis development- Week 52	7	—
Male- Penis development- Week 52	14	—
Male- Penis development- Week 104	0	—
Male- Penis development- Week 104	1	—
Male- Penis development- Week 104	0	—
Male- Penis development- Week 104	5	—
Male- Penis development- Week 104	8	—
Female- Pubic hair development- Week 52	0	—
Female- Pubic hair development- Week 52	0	—
Female- Pubic hair development- Week 52	2	—
Female- Pubic hair development- Week 52	2	—
Female- Pubic hair development- Week 52	22	—
Female- Pubic hair development- Week 104	0	—
Female- Pubic hair development- Week 104	0	—
Female- Pubic hair development- Week 104	1	—
Female- Pubic hair development- Week 104	2	—
Female- Pubic hair development- Week 104	13	—
Male- Pubic hair development- Week 52	1	—
Male- Pubic hair development- Week 52	1	—
Male- Pubic hair development- Week 52	2	—
Male- Pubic hair development- Week 52	6	—
Male- Pubic hair development- Week 52	14	—
Male- Pubic hair development- Week 104	0	—
Male- Pubic hair development- Week 104	1	—
Male- Pubic hair development- Week 104	0	—
Male- Pubic hair development- Week 104	4	—
Male- Pubic hair development- Week 104	9	—

Secondary/registry result

Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104

Time frame:Week 52, week 104

change from baseline, descriptive

Posted result

Group	Value (mean), Years	95% CI
Liraglutide 1.8 mg: Follow-up 1	1.231	—

Secondary/registry result

Growth (Height Velocity)- Week 156

Time frame:Week 0, week 156

change from baseline, descriptive

Posted result

Group	Value (mean), cm/year	95% CI
Liraglutide 1.8 mg: Follow-up 1 and 2	1.100	—

Secondary/registry result

Height Velocity SDS- Week 156

Time frame:Week 0, week 156

change from baseline, descriptive

Posted result

Group	Value (mean), SDS score	95% CI
Liraglutide 1.8 mg: Follow-up 1 and 2	0.142	—

Secondary/registry result

Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156

Time frame:Week 52, week 156

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Liraglutide 1.8 mg: Follow-up 1 and 2Female- Breast development- Week 52	0	—
Female- Breast development- Week 52	0	—
Female- Breast development- Week 52	1	—
Female- Breast development- Week 52	5	—
Female- Breast development- Week 52	21	—
Female- Breast development- Week 156	0	—
Female- Breast development- Week 156	0	—
Female- Breast development- Week 156	0	—
Female- Breast development- Week 156	3	—
Female- Breast development- Week 156	11	—
Male- Penis development- Week 52	1	—
Male- Penis development- Week 52	2	—
Male- Penis development- Week 52	0	—
Male- Penis development- Week 52	7	—
Male- Penis development- Week 52	14	—
Male- Penis development- Week 156	0	—
Male- Penis development- Week 156	0	—
Male- Penis development- Week 156	1	—
Male- Penis development- Week 156	3	—
Male- Penis development- Week 156	9	—
Female- Pubic hair development- Week 52	0	—
Female- Pubic hair development- Week 52	0	—
Female- Pubic hair development- Week 52	2	—
Female- Pubic hair development- Week 52	2	—
Female- Pubic hair development- Week 52	22	—
Female- Pubic hair development- Week 156	0	—
Female- Pubic hair development- Week 156	0	—
Female- Pubic hair development- Week 156	0	—
Female- Pubic hair development- Week 156	2	—
Female- Pubic hair development- Week 156	11	—
Male- Pubic hair development- Week 52	1	—
Male- Pubic hair development- Week 52	1	—
Male- Pubic hair development- Week 52	2	—
Male- Pubic hair development- Week 52	6	—
Male- Pubic hair development- Week 52	14	—
Male- Pubic hair development- Week 156	0	—
Male- Pubic hair development- Week 156	0	—
Male- Pubic hair development- Week 156	1	—
Male- Pubic hair development- Week 156	3	—
Male- Pubic hair development- Week 156	10	—

Secondary/registry result

Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156

Time frame:Week 52, week 156

change from baseline, descriptive

Posted result

Group	Value (mean), Years	95% CI
Liraglutide 1.8 mg: Follow-up 1 and 2	1.778	—

Secondary/protocol endpoint/low confidence

Change in Bone Age Assessment (X-ray of Left Hand and Wrist)

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Pubertal Assessment/Progression (Tanner Staging)

Time frame:Week 0, week 26, week 52

categorical status, descriptive

Secondary/protocol endpoint

Growth (Height Velocity)

Time frame:Week 0, week 26

change from baseline, descriptive

Secondary/protocol endpoint

Growth (Height Velocity)

Time frame:Week 0, week 52

change from baseline, descriptive

Secondary/protocol endpoint

Growth (Height Velocity)- Week 104

Time frame:Week 0, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Change in Pubertal Assessment/Progression (Tanner Staging)- Week 104

Time frame:Week 52, week 104

categorical status, descriptive

Secondary/protocol endpoint

Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 104

Time frame:Week 52, week 104

change from baseline, descriptive

Secondary/protocol endpoint

Growth (Height Velocity)- Week 156

Time frame:Week 0, week 156

change from baseline, descriptive

Secondary/protocol endpoint

Height Velocity SDS- Week 156

Time frame:Week 0, week 156

change from baseline, descriptive

Secondary/protocol endpoint

Change in Pubertal Assessment/Progression (Tanner Staging)- Week 156

Time frame:Week 52, week 156

categorical status, descriptive

Secondary/protocol endpoint

Change From Week 52 in Bone Age Assessment (X-ray of Left Hand and Wrist)- Week 156

Time frame:Week 52, week 156

change from baseline, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Ratio to Baseline: Fasting Glucagon

Time frame:Week 0, week 26

ratio, improvement

Secondary/protocol endpoint/low confidence

Ratio to Baseline: Fasting Glucagon

Time frame:Week 0, week 52

ratio, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial.
Pediatric obesity2021 Aug (month)PMID33634589doi:10.1111/ijpo.12778via clinicaltrials gov reference derived + pubmed nct search
Liraglutide in Children and Adolescents with Type 2 Diabetes.
The New England journal of medicine2019 Aug 15PMID31034184doi:10.1056/NEJMoa1903822via CT.gov background + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.