DUALTM IX

CompletedPhase 3Results posted

A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

420

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥20•HbA1c 7-11%

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 IDNCT02773368

Org study IDNN9068-4229

Secondary ID2015-001596-48

Secondary IDREec-2016-2248REec

Secondary IDU1111-1168-9343WHO

Timeline

Milestones

Study first posted2016-05-16estimated

Study start2016-05-23actual

Primary completion2017-09-26actual

Study completion2017-10-23actual

Results first posted2018-10-23actual

Last update posted2020-08-11actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% [53-97 mmol/mol] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m^2 and below 40 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products

Endpoints (66)

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

Safety / tolerability / PK

Weight & body composition

Patient-reported / QoL

Weight & body composition

4 endpoints

Secondary/registry result

Change 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
IDegLiraBody weight (kg) at baseline	89.3	—
Body weight (kg) change from baseline to week 26	-0.0	—
IGlarBody weight (kg) at baseline	87.2	—
Body weight (kg) change from baseline to week 26	2.0	—

Treatment Contrast-1.9295% CI-2.64 – -1.19ANCOVA

Secondary/registry result

Change From Baseline After 26 Weeks in Waist Circumference

Time frame:After 26 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
IDegLiraWaist circum. (cm) at baseline	105.9	—
Waist circum. (cm) change from baseline to week 26	-0.6	—
IGlarWaist circum. (cm) at baseline	104.7	—
Waist circum. (cm) change from baseline to week 26	0.7	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 0, Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline After 26 Weeks in Waist Circumference

Time frame:After 26 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

28 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 (mean), Percentage of glycosylated haemoglobin	95% CI
IDegLiraHbA1c (%) at baseline	8.20	—
HbA1c (%) change from baseline to week 26	-1.94	—
IGlarHbA1c (%) at baseline	8.36	—
HbA1c (%) change from baseline to week 26	-1.68	—

Treatment Contrast-0.3495% CI-0.48 – -0.20ANCOVA

Treatment Contrast-0.3695% CI-0.50 – -0.21ANCOVA

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/low confidence

Insulin Dose, Total Daily Dose (U)

Time frame:After 26 weeks

descriptive

Posted result

Group	Value (mean), Units (U)	95% CI
IDegLira	36.2	—
IGlar	53.5	—

Treatment Contrast-15.3795% CI-19.60 – -11.13ANCOVA

Secondary/registry result

Change 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 (mean), mmol/ L	95% CI
IDegLiraFPG (mmol/L) at baseline	9.51	—
FPG (mmol/L) change from baseline to week 26	-3.72	—
IGlarFPG (mmol/L) at baseline	9.57	—
FPG (mmol/L) change from baseline to week 26	-3.50	—

Secondary/registry result

Responder (Yes/No) for HbA1c Below 7.0%

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
IDegLiraYes	167	—
No	30	—
IGlarYes	144	—
No	58	—

Secondary/registry result

Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
IDegLiraYes	91	—
No	106	—
IGlarYes	38	—
No	164	—

Secondary/registry result

Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
IDegLiraYes	156	—
No	41	—
IGlarYes	114	—
No	88	—

Secondary/registry result

Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
IDegLiraYes	83	—
No	114	—
IGlarYes	34	—
No	168	—

Secondary/registry result

Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
IDegLiraYes	147	—
No	50	—
IGlarYes	100	—
No	102	—

Secondary/registry result

Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Participants	95% CI
IDegLiraYes	84	—
No	113	—
IGlarYes	26	—
No	176	—

Secondary/registry result

Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Particpants	95% CI
IDegLiraYes	137	—
No	60	—
IGlarYes	79	—
No	123	—

Secondary/registry result

Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Partcipants	95% CI
IDegLiraYes	77	—
No	120	—
IGlarYes	24	—
No	178	—

Secondary/registry result

Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile

Time frame:After 26 weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
IDegLiraBefore breakfast - Baseline	9.01	—
Ninety (90) minutes after breakfast - Baseline	11.79	—
Before lunch - Baseline	8.93	—
Ninety (90) minutes after lunch - Baseline	11.24	—
Before dinner - Baseline	9.33	—
Ninety (90) minutes after dinner - Baseline	11.40	—
At bedtime - Baseline	10.38	—
At 4.00 AM - Baseline	8.80	—
Before breakfast the following day - Baseline	8.60	—
Before breakfast - Week 26	5.40	—
Ninety (90) minutes after breakfast - Week 26	7.20	—
Before lunch - Week 26	5.83	—
Ninety (90) minutes after lunch - Week 26	7.25	—
Before dinner - Week 26:	6.43	—
Ninety (90) minutes after dinner - Week 26	7.85	—
At bedtime - Week 26	7.05	—
At 4.00 AM - Week 26	5.58	—
Before breakfast the following day - Week 26	5.23	—
IGlarBefore breakfast - Baseline	9.00	—
Ninety (90) minutes after breakfast - Baseline	11.77	—
Before lunch - Baseline	9.20	—
Ninety (90) minutes after lunch - Baseline	11.22	—
Before dinner - Baseline	9.36	—
Ninety (90) minutes after dinner - Baseline	11.40	—
At bedtime - Baseline	10.71	—
At 4.00 AM - Baseline	9.00	—
Before breakfast the following day - Baseline	8.81	—
Before breakfast - Week 26	5.39	—
Ninety (90) minutes after breakfast - Week 26	8.35	—
Before lunch - Week 26	6.35	—
Ninety (90) minutes after lunch - Week 26	8.49	—
Before dinner - Week 26:	6.77	—
Ninety (90) minutes after dinner - Week 26	8.70	—
At bedtime - Week 26	7.79	—
At 4.00 AM - Week 26	5.72	—
Before breakfast the following day - Week 26	5.36	—

Secondary/registry result

Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile

Time frame:After 26 weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
IDegLiraMean 9-point SMPG (mmol/L) at baseline	9.98	—
Mean 9-point SMPG change from baseline to week 26	-3.47	—
IGlarMean 9-point SMPG (mmol/L) at baseline	10.06	—
Mean 9-point SMPG change from baseline to week 26	-2.98	—

Secondary/registry result

Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments

Time frame:After 26 weeks

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
IDegLiraBaseline	2.38	—
Change from baseline to week 26	-0.86	—
IGlarBaseline	2.28	—
Change from baseline to week 26	-0.09	—

Secondary/protocol endpoint

Insulin Dose, Total Daily Dose (U)

Time frame:After 26 weeks

descriptive

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Week 0, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Responder (Yes/No) for HbA1c Below 7.0%

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain

Time frame:After 26 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time frame:After 26 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile

Time frame:After 26 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile

Time frame:After 26 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Time frame:After 26 weeks

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

18 endpoints

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Cholesterol

Time frame:After 26 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (median), mmol/L	95% CI
IDegLiraTotal cholesterol (mmol/L) at baseline	4.42	2.02 – 10.62
Total cholesterol (mmol/L) at week 26	4.27	2.12 – 9.87
IGlarTotal cholesterol (mmol/L) at baseline	4.45	2.12 – 11.37
Total cholesterol (mmol/L) at week 26	4.27	1.84 – 9.40

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)

Time frame:After 26 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (median), mmol/L	95% CI
IDegLiraLDL cholesterol (mmol/L) at baseline	2.28	0.26 – 7.10
LDL cholesterol (mmol/L) at week 26	2.20	0.57 – 6.42
IGlarLDL cholesterol (mmol/L) at baseline	2.28	0.10 – 6.73
LDL cholesterol (mmol/L) at week 26	2.31	0.62 – 5.34

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)

Time frame:After 26 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (median), mmol/L	95% CI
IDegLiraHDL cholesterol (mmol/L) at baseline	1.14	0.57 – 2.69
HDL cholesterol (mmol/L) at week 26	1.17	0.57 – 2.72
IGlarHDL cholesterol (mmol/L) at baseline	1.14	0.31 – 2.59
HDL cholesterol (mmol/L) at week 26	1.17	0.36 – 2.49

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)

Time frame:After 26 weeks

VLDL, change

change from baseline, improvement

Posted result

Group	Value (median), mmol/L	95% CI
IDegLiraVLDL cholesterol (mmol/L) at baseline	0.75	0.18 – 8.60
VLDL cholesterol (mmol/L) at week 26	0.70	0.21 – 5.75
IGlarVLDL cholesterol (mmol/L) at baseline	0.80	0.21 – 8.13
VLDL cholesterol (mmol/L) at week 26	0.67	0.21 – 3.32

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Triglycerides

Time frame:After 26 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (median), mmol/L	95% CI
IDegLiraTriglycerides (mmol/L) at baseline	1.67	0.38 – 23.60
Triglycerides (mmol/L) at week 26	1.55	0.46 – 17.03
IGlarTriglycerides (mmol/L) at baseline	1.73	0.43 – 27.80
Triglycerides (mmol/L) at week 26	1.47	0.47 – 8.81

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Free Fatty Acids

Time frame:After 26 weeks

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (median), mmol/L	95% CI
IDegLiraFree fatty acids (mmol/L) at baseline	0.58	0.08 – 1.44
Free fatty acids (mmol/L) at week 26	0.38	0.10 – 0.92
IGlarFree fatty acids (mmol/L) at baseline	0.61	0.06 – 1.73
Free fatty acids (mmol/L) at week 26	0.42	0.02 – 1.30

Secondary/registry result

Change From Baseline in Systolic Blood Pressure

Time frame:After 26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
IDegLiraSystolic BP (mmHg) at baseline	130.5	—
Systolic BP (mmHg) change from baseline to week 26	-3.0	—
IGlarSystolic BP (mmHg) at baseline	128.9	—
Systolic BP (mmHg) change from baseline to week 26	0.6	—

Secondary/registry result

Change From Baseline in Diastolic Blood Pressure

Time frame:After 26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
IDegLiraDiastolic (mmHg) at baseline	79.4	—
Diastolic (mmHg) change from baseline to week 26	-1.2	—
IGlarDiastolic (mmHg) at baseline	78.9	—
Diastolic (mmHg) change from baseline to week 26	-1.1	—

Secondary/registry result

Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate

Time frame:After 26 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats/minute	95% CI
IDegLiraPulse (beats/min) at baseline	76.1	—
Pulse (beats/min) change from baseline to week 26	2.0	—
IGlarPulse (beats/min) at baseline	75.0	—
Pulse (beats/min) change from baseline to week 26	-0.4	—

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Cholesterol

Time frame:After 26 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)

Time frame:After 26 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)

Time frame:After 26 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)

Time frame:After 26 weeks

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Triglycerides

Time frame:After 26 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Free Fatty Acids

Time frame:After 26 weeks

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure

Time frame:After 26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure

Time frame:After 26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate

Time frame:After 26 weeks

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)

Time frame:After 26 weeks

SF-36 total

change from baseline, improvement

Posted result

Group	Value (median), Scores on a scale	95% CI
IDegLiraOverall physical - Baseline	51.3	22.0 – 61.6
Overall physical - Week 26	53.2	22.9 – 64.0
Overall mental - Baseline	53.3	15.6 – 67.9
Overall mental - Week 26	54.4	14.8 – 68.3
IGlarOverall physical - Baseline	51.5	21.9 – 62.4
Overall physical - Week 26	54.6	25.0 – 65.6
Overall mental - Baseline	53.3	19.7 – 68.8
Overall mental - Week 26	54.4	31.0 – 67.3

Secondary/registry result

Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)

Time frame:After 26 weeks

change from baseline, improvement

Posted result

Group	Value (median), Scores on a scale	95% CI
IDegLiraTRIM-D scores at baseline	75.9	44.6 – 100.0
TRIM-D scores at week 26	84.4	37.5 – 100.0
IGlarTRIM-D scores at baseline	75.9	38.4 – 100.0
TRIM-D scores at week 26	83.9	44.6 – 100.0

Secondary/protocol endpoint

Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)

Time frame:After 26 weeks

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)

Time frame:After 26 weeks

change from baseline, improvement

Safety / tolerability / PK

12 endpoints

Secondary/registry result

Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
IDegLira	38	—
IGlar	95	—

Treatment Ratio0.4295% CI0.23 – 0.75Negative binomial regression model

Secondary/registry result

Number of Treatment-emergent Adverse Events

Time frame:Week 0-26

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Number of events	95% CI
IDegLira	450	—
IGlar	386	—

Secondary/registry result

Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks

Time frame:Week 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Number of episodes	95% CI
IDegLira	6	—
IGlar	13	—

Secondary/registry result

Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks

Time frame:Week 0-26

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Number of episodes	95% CI
IDegLiraSevere - ADA	1	—
Documented symptomatic - ADA	239	—
Asymptomatic - ADA	850	—
Probably symptomatic - ADA	23	—
Pseudo - ADA	10	—
Unclassifiable hypoglycaemia - ADA	2	—
IGlarSevere - ADA	0	—
Documented symptomatic - ADA	419	—
Asymptomatic - ADA	902	—
Probably symptomatic - ADA	5	—
Pseudo - ADA	14	—
Unclassifiable hypoglycaemia - ADA	0	—

Secondary/registry result

Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)

Time frame:After 26 weeks

categorical status, descriptive

Posted result

Group	Value (number), Number of subjects	95% CI
IDegLiraScreening, Normal	142	—
Screening, Abnormal NCS	66	—
Screening, Abnormal CS	1	—
Screening, Missing	0	—
Week 26, Normal	134	—
Week 26, Abnormal NCS	58	—
Week 26, Abnormal CS	2	—
Week 26, Missing	0	—
IGlarScreening, Normal	141	—
Screening, Abnormal NCS	69	—
Screening, Abnormal CS	0	—
Screening, Missing	0	—
Week 26, Normal	136	—
Week 26, Abnormal NCS	64	—
Week 26, Abnormal CS	0	—
Week 26, Missing	0	—

Secondary/registry result

Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography

Time frame:After 26 weeks

categorical status, descriptive

Posted result

Group	Value (number), Number of subjects	95% CI
IDegLiraScreening, Left eye (Normal)	134	—
Screening, Left eye (Abnormal -NCS)	68	—
Screening, Left eye (Abnormal-CS)	7	—
Screening, Left eye (Missing)	0	—
Week 26, Left eye (Normal)	123	—
Week 26, Left eye (Abnormal -NCS)	66	—
Week 26, Left eye (Abnormal-CS)	2	—
Week 26, Left eye (Missing)	0	—
Screening, Right eye (Normal)	133	—
Screening, Right eye (Abnormal-NCS)	69	—
Screening, Right eye (Abnormal- CS)	7	—
Screening, Right eye (Missing)	0	—
Week 26, Right eye (Normal)	120	—
Week 26, Right eye (Abnormal-NCS)	69	—
Week 26, Right eye (Abnormal- CS)	2	—
Week 26, Right eye (Missing)	0	—
IGlarScreening, Left eye (Normal)	131	—
Screening, Left eye (Abnormal -NCS)	74	—
Screening, Left eye (Abnormal-CS)	4	—
Screening, Left eye (Missing)	0	—
Week 26, Left eye (Normal)	125	—
Week 26, Left eye (Abnormal -NCS)	68	—
Week 26, Left eye (Abnormal-CS)	4	—
Week 26, Left eye (Missing)	0	—
Screening, Right eye (Normal)	133	—
Screening, Right eye (Abnormal-NCS)	72	—
Screening, Right eye (Abnormal- CS)	4	—
Screening, Right eye (Missing)	0	—
Week 26, Right eye (Normal)	127	—
Week 26, Right eye (Abnormal-NCS)	66	—
Week 26, Right eye (Abnormal- CS)	4	—
Week 26, Right eye (Missing)	0	—

Secondary/protocol endpoint

Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Week 0-26

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events

Time frame:Week 0-26

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks

Time frame:Week 0-26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks

Time frame:Week 0-26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)

Time frame:After 26 weeks

categorical status, descriptive

Secondary/protocol endpoint

Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography

Time frame:After 26 weeks

categorical status, descriptive

Publications (1)

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

Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes.
Diabetes, obesity & metabolism2019 Jun (month)PMID30761720doi:10.1111/dom.13666via CT.gov reference

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.