GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)

Effects of Intervention With the Glucagon-like Peptide 1 (GLP-1) Analog Liraglutide Plus Metformin Versus Metformin Monotherapy in Overweight/Obese Women With Metabolic Defects and Recent History of Gestational Diabetes Mellitus (GDM)

Lead sponsor

Woman's

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

153

actual

Study population

Gestational diabetes, Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criteria

•BMI ≥25•Female

Primary endpoint

•Insulin Secretion-Sensitivity Index (IS-SI)

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 IDNCT01234649

Org study IDRP10-012

Timeline

Milestones

Study first posted2010-11-04estimated

Study start2011-08-11actual

Primary completion2019-04-24actual

Study completion2019-06-14actual

Last update posted2019-07-26actual

Results first posted2019-07-26actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Gestational diabetesObesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•Adult female 18 years to 45 years of age who experienced GDM within 52 weeks of index pregnancy

•Actual BMI >25 kg/ m2

•Written consent for participation in the study

•Patient completed lactation

•Dysglycemia (impaired fasting glucose [IFG}, impaired glucose tolerance [IGT} or IFG/IGT) and/or ß-cell dysfunction postpartum requiring pharmacological intervention (except type 1 or 2 diabetes)

Exclusion criteria

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2

•History of pancreatitis

•Significant cardiovascular, cerebrovascular, renal, or hepatobiliary diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology)

•Serum liver enzymes (AST and/or ALT levels) exceeding more than twice normal laboratory values

•Uncontrolled hypertension (systolic blood pressure>150 mm Hg and/or diastolic blood pressure >90 mm Hg)

•Fasting serum triglycerides ≥800 mg/dl at screening. Lipid-lowering medications must have been maintained at the same dose for 3 months prior to enrollment

•Hematological profiles considered to be clinically significant

•Cholestasis during the past pregnancy

•Presence of contradictions for GLP-1 receptor agonist or metformin administration such as allergy or hypersensitivity

•Current use of metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors or GLP-1 receptor agonist medications.

•Use of drugs known to exacerbate glucose tolerance.

•Use of prescription or over-the-counter weight-loss drugs

•Diabetes postpartum or history of diabetes or prior use of medications to treat diabetes except gestational diabetes

•Creatinine clearance less than 60 ml/min

•History or currently undergoing chemotherapy or radiotherapy for cancer

•Pregnancy planned during the coming two years

•Currently breastfeeding

•Exclusion criteria include any condition, which in the opinion of the investigator would place the subject at increased risk or otherwise make the subject unsuitable for participation in the study

Endpoints (44)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

MASH / liver

Weight & body composition

12 endpoints

Secondary/registry result

Absolute Body Weight

Time frame:84 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilograms	95% CI
Metformin XR Plus Liraglutide	94.2	—
Metformin XR Plus Placebo	91.3	—

p<0.048ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)

Time frame:Change from baseline (time 0) to study end (84 weeks)

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change in weight from baseline	95% CI
Metformin XR Plus Liraglutide	-7.2	—
Metformin XR Plus Placebo	-3.1	—

p<0.04ANOVA

Secondary/registry result

Body Mass Index (BMI)

Time frame:84 weeks of treatment

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), weight (kg) /height (m) squared	95% CI
Metformin XR Plus Liraglutide	33.8	—
Metformin XR Plus Placebo	32.8	—

p<0.047ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Waist Circumference (WC)

Time frame:84 weeks of treatment

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeters	95% CI
Metformin XR Plus Liraglutide	94.3	—
Metformin XR Plus Placebo	95.3	—

p<0.023ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Waist-to-Hip Ratio (WHR)

Time frame:84 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio of waist/hip circumference	95% CI
Metformin XR Plus Liraglutide	.81	—
Metformin XR Plus Placebo	.81	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Waist to Height Ratio (WHtR)

Time frame:84 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio of waist /height	95% CI
Metformin XR Plus Liraglutide	.56	—
Metformin XR Plus Placebo	.57	—

p0.042ANOVA

Factorial repeated measures ANOVA

Secondary/protocol endpoint

Absolute Body Weight

Time frame:84 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)

Time frame:Change from baseline (time 0) to study end (84 weeks)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Body Mass Index (BMI)

Time frame:84 weeks of treatment

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Waist Circumference (WC)

Time frame:84 weeks of treatment

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Waist-to-Hip Ratio (WHR)

Time frame:84 weeks of treatment

ratio, improvement

Secondary/protocol endpoint

Waist to Height Ratio (WHtR)

Time frame:84 weeks of treatment

ratio, improvement

Glycemic / diabetes

12 endpoints

Primary/registry result

Insulin Secretion-Sensitivity Index (IS-SI)

Time frame:84 weeks of treatment

change from baseline, improvement

Posted result

Group	Value (mean), index	95% CI
Metformin XR Plus Liraglutide	418.4	—
Metformin XR Plus Placebo	333	—

p<0.04ANOVA

Factorial repeated measures design

Primary/protocol endpoint

Insulin Secretion-Sensitivity Index (IS-SI)

Time frame:84 weeks of treatment

change from baseline, improvement

Secondary/registry result

Fasting Blood Glucose (FBG)

Time frame:84 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Metformin XR Plus Liraglutide	90	—
Metformin XR Plus Placebo	91.7	—

p<.005ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Mean Glucose During OGTT (MBG)

Time frame:84 weeks of treatment

descriptive, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Metformin XR Plus Liraglutide	121.6	—
Metformin XR Plus Placebo	118.8	—

p<0.011ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Time frame:84 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), index	95% CI
Metformin XR Plus Liraglutide	2.2	—
Metformin XR Plus Placebo	2.45	—

p>0.05ANOVA

Nested repeated measures design

Secondary/registry result

Matsuda Insulin Sensitivity Index Derived From OGTT

Time frame:84 weeks of treatment

change from baseline, improvement

Posted result

Group	Value (mean), index	95% CI
Metformin XR Plus Liraglutide	5.9	—
Metformin XR Plus Placebo	5.4	—

p<0.03ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Insulinogenic Index (IGI) /HOMA-IR

Time frame:84 weeks of treatment

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

Group	Value (mean), index	95% CI
Metformin XR Plus Liraglutide	0.8	—
Metformin XR Plus Placebo	0.62	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/protocol endpoint

Fasting Blood Glucose (FBG)

Time frame:84 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Glucose During OGTT (MBG)

Time frame:84 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

Time frame:84 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Matsuda Insulin Sensitivity Index Derived From OGTT

Time frame:84 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Insulinogenic Index (IGI) /HOMA-IR

Time frame:84 weeks of treatment

HOMA-IR (insulin sensitivity)

ratio, improvement

MASH / liver

6 endpoints

Secondary/registry result

Alanine Aminotransferase (ALT) Levels

Time frame:84 weeks of treatment

ALT, change

change from baseline, improvement

LOINC 1742-6

Posted result

Group	Value (mean), U/L	95% CI
Metformin XR Plus Liraglutide	32.3	—
Metformin XR Plus Placebo	31	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Aspartate Aminotransferase (AST)

Time frame:84 weeks of treatment

AST, change

change from baseline, improvement

LOINC 1920-8

Posted result

Group	Value (mean), U/L	95% CI
Metformin XR Plus Liraglutide	27	—
Metformin XR Plus Placebo	28	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Alanine Aminotransferase /Aspartate Aminotransferase (ALT/AST) Ratio

Time frame:84 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio of ALT (U/L)/ AST (U/L)	95% CI
Metformin XR Plus Liraglutide	1.2	—
Metformin XR Plus Placebo	1.18	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/protocol endpoint

Alanine Aminotransferase (ALT) Levels

Time frame:84 weeks of treatment

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Aspartate Aminotransferase (AST)

Time frame:84 weeks of treatment

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Alanine Aminotransferase /Aspartate Aminotransferase (ALT/AST) Ratio

Time frame:84 weeks of treatment

ratio, improvement

Cardiometabolic biomarkers

14 endpoints

Secondary/registry result

Total Cholesterol (CHOL) Levels

Time frame:84 weeks of treatment

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mg/dL	95% CI
Metformin XR Plus Liraglutide	183.7	—
Metformin XR Plus Placebo	183.8	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

High Density Lipoprotein Cholesterol (HDL-C) Levels

Time frame:84 weeks of treatment

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mg/dL	95% CI
Metformin XR Plus Liraglutide	51	—
Metformin XR Plus Placebo	48.7	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Low Density Lipoprotein Cholesterol (LDL-C) Levels

Time frame:84 weeks of treatment

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mg/dL	95% CI
Metformin XR Plus Liraglutide	110	—
Metformin XR Plus Placebo	107	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Triglyceride (TRG) Levels

Time frame:84 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mg/dL	95% CI
Metformin XR Plus Liraglutide	120	—
Metformin XR Plus Placebo	125	—

p<0.046ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Triglyceride to High Density Lipoprotein Cholesterol Ratio TRG/HDL-C)

Time frame:84 weeks of treatment

ratio, improvement

Posted result

Group	Value (mean), ratio of TRG (mg/dL)/HDL-C (mg/dl)	95% CI
Metformin XR Plus Liraglutide	2.56	—
Metformin XR Plus Placebo	2.95	—

p<0.049ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Systolic Blood Pressure

Time frame:84 weeks of treatment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Metformin XR Plus Liraglutide	122	—
Metformin XR Plus Placebo	123	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/registry result

Diastolic Blood Pressure

Time frame:84 weeks of treatment

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Metformin XR Plus Liraglutide	77.6	—
Metformin XR Plus Placebo	77	—

p>0.05ANOVA

Factorial repeated measures ANOVA

Secondary/protocol endpoint

Total Cholesterol (CHOL) Levels

Time frame:84 weeks of treatment

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

High Density Lipoprotein Cholesterol (HDL-C) Levels

Time frame:84 weeks of treatment

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Low Density Lipoprotein Cholesterol (LDL-C) Levels

Time frame:84 weeks of treatment

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Triglyceride (TRG) Levels

Time frame:84 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Triglyceride to High Density Lipoprotein Cholesterol Ratio TRG/HDL-C)

Time frame:84 weeks of treatment

ratio, improvement

Secondary/protocol endpoint

Systolic Blood Pressure

Time frame:84 weeks of treatment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic Blood Pressure

Time frame:84 weeks of treatment

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

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

Postpartum treatment with liraglutide in combination with metformin versus metformin monotherapy to improve metabolic status and reduce body weight in overweight/obese women with recent gestational diabetes: A double-blind, randomized, placebo-controlled study.
Journal of diabetes and its complications2020 Apr (month)PMID32046931doi:10.1016/j.jdiacomp.2020.107548via clinicaltrials gov reference derived + 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.