GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT02964247

CompletedPhase 3Results posted

LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors.

LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

303

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-9.5%

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 IDNCT02964247

Org study IDNN2211-4315

Secondary IDU1111-1184-8086WHO

Timeline

Milestones

Study first posted2016-11-16estimated

Study start2017-03-03actual

Primary completion2018-05-04actual

Study completion2018-05-08actual

Results first posted2019-07-10actual

Last update posted2020-11-17actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

•Male or female, age 18 years or older at the time of signing informed consent.

•Diagnosed with type 2 diabetes mellitus.

•HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).

•Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (1500 mg or more, or maximum tolerated dose) for at least 90 days prior to the day of screening. All medications in compliance with current local label.

•Body mass index of 20 kg/m^2 or above.

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).

•History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.

•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 60 mL/min/1.73m^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening.

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days during the 90 days prior to screening is allowed.

•Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative.

•History or presence of pancreatitis (acute or chronic).

•Impaired liver function, defined as ALT 2.5 or more times upper normal limit at screening.

•Subjects presently classified as being in New York Heart Association (NYHA) Class IV.

Endpoints (52)

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

Weight & body composition

Safety / tolerability / PK

Weight & body composition

8 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
Liraglutidein-trial obs. period	-2.84	—
on-treatment without rescue medication obs. period	-2.89	—
Placeboin-trial obs. period	-2.02	—
on-treatment without rescue medication obs. period	-2.09	—

Treatment difference-0.8295% CI-1.73 – 0.09p0.077pattern mixture model

Treatment difference-0.8695% CI-1.77 – 0.04p0.062Mixed Models Analysis

Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Week 0, Week 26

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m^2	95% CI
Liraglutide	-1.02	—
Placebo	-0.72	—

Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, Week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Liraglutide	-4.28	—
Placebo	-1.77	—

Secondary/registry result

Subjects Who Achieve Weight Loss by 3% or More

Time frame:Week 26

pct weight loss 3pct

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
LiraglutideYes	46.43	—
No	53.57	—
PlaceboYes	41.24	—
No	58.76	—

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 in Body Mass Index (BMI)

Time frame:Week 0, Week 26

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, Week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Subjects Who Achieve Weight Loss by 3% or More

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Glycemic / diabetes

24 endpoints

Primary/registry result

Change in HbA1c

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Liraglutidein-trial obs. period	-1.00	—
on-treatment without rescue medication obs. period	-1.05	—
Placeboin-trial obs. period	-0.32	—
on-treatment without rescue medication obs. period	-0.35	—

Treatment difference-0.6895% CI-0.89 – -0.48p<.001pattern mixture model

Treatment difference-0.7495% CI-0.94 – -0.53p<.001Mixed Models Analysis

Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in Fasting Plasma Glucose

Time frame:Week 0, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), milligram/dL	95% CI
Liraglutide	-27.00	—
Placebo	-11.97	—

Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
LiraglutideYes	51.79	—
No	48.21	—
PlaceboYes	23.16	—
No	76.84	—

Secondary/registry result

Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
LiraglutideYes	34.36	—
No	65.64	—
PlaceboYes	9.47	—
No	90.53	—

Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain.

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
LiraglutideYes	47.69	—
No	52.31	—
PlaceboYes	19.15	—
No	80.85	—

Secondary/registry result

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%.

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

Group	Value (number), Percentage of Participants	95% CI
LiraglutideYes	29.74	—
No	70.26	—
PlaceboYes	7.45	—
No	92.55	—

Secondary/registry result

Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile

Time frame:Week 0, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), milligram/dL	95% CI
Liraglutide	-33.93	—
Placebo	-18.85	—

Secondary/registry result

Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals)

Time frame:Week 0, Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), milligram/dL	95% CI
Liraglutide	-11.06	—
Placebo	-4.44	—

Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
LiraglutideYes	47.69	—
No	52.31	—
PlaceboYes	19.15	—
No	80.85	—

Secondary/registry result

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg.

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Systolic BP, change

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
LiraglutideYes	42.05	—
No	57.95	—
PlaceboYes	18.09	—
No	81.91	—

Secondary/registry result

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol)

Time frame:Week 26

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
LiraglutideYes	52.31	—
No	47.69	—
PlaceboYes	16.84	—
No	83.16	—

Secondary/registry result

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain

Time frame:Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
LiraglutideYes	45.13	—
No	54.87	—
PlaceboYes	14.89	—
No	85.11	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:Week 0, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain.

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%.

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c, change, ≥5% weight-loss responders

Secondary/protocol endpoint

Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile

Time frame:Week 0, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals)

Time frame:Week 0, Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, % change

LOINC 4548-4

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg.

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Systolic BP, change, Body weight, absolute change (kg)

Secondary/protocol endpoint

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol)

Time frame:Week 26

HbA1c, change

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c, change, Body weight, absolute change (kg)

Cardiometabolic biomarkers

16 endpoints

Secondary/registry result

Change in Fasting Blood Lipids - 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	0.95	—
Placebo	0.99	—

Secondary/registry result

Change in Fasting Blood Lipids - 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	0.97	—
Placebo	1.01	—

Secondary/registry result

Change in Fasting Blood Lipids - 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	1.05	—
Placebo	1.01	—

Secondary/registry result

Change in Fasting Blood Lipids - 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	0.83	—
Placebo	0.94	—

Secondary/registry result

Change in Fasting Blood Lipids-triglycerides

Time frame:Week 0, Week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Liraglutide	0.81	—
Placebo	0.93	—

Secondary/registry result

Change in Fasting Blood Lipids- Free Fatty Acids (FFA)

Time frame:Week 0, Week 26

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio	95% CI
Liraglutide	0.80	—
Placebo	0.86	—

Secondary/registry result

Change in Systolic Blood Pressure

Time frame:Week 0, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide	-1.95	—
Placebo	-3.35	—

Secondary/registry result

Change in Diastolic Blood Pressure

Time frame:Week 0, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide	-0.72	—
Placebo	-1.12	—

Secondary/protocol endpoint

Change in Fasting Blood Lipids - Total Cholesterol

Time frame:Week 0, Week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in Fasting Blood Lipids - Low Density Lipoprotein (LDL) Cholesterol

Time frame:Week 0, Week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Fasting Blood Lipids - High Density Lipoprotein (HDL) Cholesterol

Time frame:Week 0, Week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Fasting Blood Lipids - Very Low Density Lipoprotein (VLDL) Cholesterol

Time frame:Week 0, Week 26

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Blood Lipids-triglycerides

Time frame:Week 0, Week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Fasting Blood Lipids- Free Fatty Acids (FFA)

Time frame:Week 0, Week 26

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Week 0, Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:Week 0, Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events

Time frame:Week 0 - 26 + 7 days

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Liraglutide	426	—
Placebo	106	—

Secondary/registry result

Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes

Time frame:Week 0 - 26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Liraglutide	0	—
Placebo	3	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events

Time frame:Week 0 - 26 + 7 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes

Time frame:Week 0 - 26

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

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

Efficacy of liraglutide added to sodium-glucose cotransporter-2 inhibitors in type 2 diabetes, stratified by baseline characteristics: Post-hoc analysis of LIRA-ADD2SGLT2i.
Diabetes, obesity & metabolism2021 Oct (month)PMID34132018doi:10.1111/dom.14464via clinicaltrials gov reference derived + pubmed nct search
Liraglutide as add-on to sodium-glucose co-transporter-2 inhibitors in patients with inadequately controlled type 2 diabetes: LIRA-ADD2SGLT2i, a 26-week, randomized, double-blind, placebo-controlled trial.
Diabetes, obesity & metabolism2020 Jun (month)PMID31984646doi:10.1111/dom.13978via 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.