Trial · NCT01234649

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

NCT01234649, Phase 3, Completed, Woman's; results first posted 2019-07-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM). Trials, record NCT01234649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01234649

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)
NCT number: NCT01234649
Status: Completed
Phases: Phase 3
Enrollment: 153 participants, actual
Lead sponsor: Woman's
Conditions: Gestational Diabetes Mellitus, Type 2 Diabetes Mellitus, Metabolic Syndrome, Impaired Glucose Tolerance, Disorder of Glucose Regulation
Interventions: Metformin XR plus placebo, Metformin XR plus liraglutide
First posted: 2010-11-04
Last updated: 2019-07-26
Results first posted: 2019-07-26
Limitations and caveats: A large percentage of patients did not complete the trial with the greatest loss from first study visit to second visit. A greater loss was seen initially in the metformin only group.

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Insulin Secretion-Sensitivity Index (IS-SI)	84 weeks of treatment	IS-SI in liraglutide-metformin (LIRA-MET) therapy compared to metformin alone (PLacebo-MET)
Secondary	Fasting Blood Glucose (FBG)	84 weeks of treatment	Fasting glucose levels in LIRA-MET group compared with PL-MET group
Secondary	Mean Glucose During OGTT (MBG)	84 weeks of treatment	MBG derived from average glucose measured during OGTT in LIRA-MET group compared with PL-MET group
Secondary	Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	84 weeks of treatment	HOMA-IR, a measure of insulin resistance derived from fasting values, in LIRA-MET group compared with PL-MET group
Secondary	Matsuda Insulin Sensitivity Index Derived From OGTT	84 weeks of treatment	OGTT- derived insulin sensitivity index in LIRA-MET group compared with PL-MET group
Secondary	Insulinogenic Index (IGI) /HOMA-IR	84 weeks of treatment	IGI/HOMA-IR, a measure of early insulin response corrected by fasting insulin resistance, in LIRA-MET group compared with PL-MET group
Secondary	Absolute Body Weight	84 weeks of treatment	Body weight in LIRA-MET group compared with PL-MET group
Secondary	Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)	Change from baseline (time 0) to study end (84 weeks)	Change in body weight from baseline to end o f study in LIRA-MET group compared with PL-MET group. The number was derived from final weight minus baseline and normalized to a percent.
Secondary	Body Mass Index (BMI)	84 weeks of treatment	BMI, a measure of total body adiposity, in LIRA-MET group compared with PL-MET group
Secondary	Waist Circumference (WC)	84 weeks of treatment	Waist size (measure of truncal adiposity) with LIRA-MET compared to PL-MET

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Insulin Secretion-Sensitivity Index (IS-SI)	84 weeks of treatment	index	MEAN
SECONDARY	Fasting Blood Glucose (FBG)	84 weeks of treatment	mg/dL	MEAN
SECONDARY	Mean Glucose During OGTT (MBG)	84 weeks of treatment	mg/dL	MEAN
SECONDARY	Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	84 weeks of treatment	index	MEAN
SECONDARY	Matsuda Insulin Sensitivity Index Derived From OGTT	84 weeks of treatment	index	MEAN
SECONDARY	Insulinogenic Index (IGI) /HOMA-IR	84 weeks of treatment	index	MEAN
SECONDARY	Absolute Body Weight	84 weeks of treatment	kilograms	MEAN
SECONDARY	Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline)	Change from baseline (time 0) to study end (84 weeks)	percent change in weight from baseline	MEAN
SECONDARY	Body Mass Index (BMI)	84 weeks of treatment	weight (kg) /height (m) squared	MEAN
SECONDARY	Waist Circumference (WC)	84 weeks of treatment	centimeters	MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Insulin Secretion-Sensitivity Index (IS-SI)	Metformin XR Plus Liraglutide	418.4	Standard Deviation 387	index
Insulin Secretion-Sensitivity Index (IS-SI)	Metformin XR Plus Placebo	333	Standard Deviation 206	index
Fasting Blood Glucose (FBG)	Metformin XR Plus Liraglutide	90	Standard Deviation 6.4	mg/dL
Fasting Blood Glucose (FBG)	Metformin XR Plus Placebo	91.7	Standard Deviation 8.4	mg/dL
Mean Glucose During OGTT (MBG)	Metformin XR Plus Liraglutide	121.6	Standard Deviation 20.8	mg/dL
Mean Glucose During OGTT (MBG)	Metformin XR Plus Placebo	118.8	Standard Deviation 18.9	mg/dL
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	Metformin XR Plus Liraglutide	2.2	Standard Deviation 1.4	index
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	Metformin XR Plus Placebo	2.45	Standard Deviation 1.5	index
Matsuda Insulin Sensitivity Index Derived From OGTT	Metformin XR Plus Liraglutide	5.9	Standard Deviation 2.9	index
Matsuda Insulin Sensitivity Index Derived From OGTT	Metformin XR Plus Placebo	5.4	Standard Deviation 3.2	index

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin XR Plus Liraglutide	78
Overall Study	STARTED	Metformin XR Plus Placebo	75
Overall Study	COMPLETED	Metformin XR Plus Liraglutide	35
Overall Study	COMPLETED	Metformin XR Plus Placebo	37
Overall Study	NOT COMPLETED	Metformin XR Plus Liraglutide	43
Overall Study	NOT COMPLETED	Metformin XR Plus Placebo	38

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Allergic reaction to liraglutide	Immune system disorders	Metformin XR Plus Liraglutide	1	78	1
other	Allergic reaction to liraglutide	Immune system disorders	Metformin XR Plus Placebo	0	75	0
other	Nausea	Gastrointestinal disorders	Metformin XR Plus Liraglutide	29	78	29
other	Nausea	Gastrointestinal disorders	Metformin XR Plus Placebo	2	75	2
other	Diarrhea	Gastrointestinal disorders	Metformin XR Plus Liraglutide	14	78	14
other	Diarrhea	Gastrointestinal disorders	Metformin XR Plus Placebo	13	75	13

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin XR Plus Liraglutide	0	78
Total, all-cause mortality	Metformin XR Plus Placebo	0	75
Total, other adverse events	Metformin XR Plus Liraglutide	30	78
Total, other adverse events	Metformin XR Plus Placebo	14	75
Total, serious adverse events	Metformin XR Plus Liraglutide	0	78
Total, serious adverse events	Metformin XR Plus Placebo	0	75

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32046931	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Metformin XR Plus Liraglutide vs Metformin XR Plus Placebo: deaths from any cause	Trial comparisons
Metformin XR Plus Liraglutide vs Metformin XR Plus Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01234649

GET https://conductscience.org/api/trials/v1/NCT01234649/registered?page=2

API reference For AI assistants