Study S000625

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)

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan (PDF)Informed Consent Form (PDF)

Registration

Registration: NCT01234649
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: TRIPLE
Status: COMPLETED
Enrollment: 153
Start: 2011-08-11
Primary completion: 2019-04-24
Lead sponsor: Woman's
Conditions: Gestational Diabetes Mellitus; Type 2 Diabetes Mellitus; Metabolic Syndrome; Impaired Glucose Tolerance; Disorder of Glucose Regulation
Interventions: DRUG:Metformin XR plus placebo; DRUG:Metformin XR plus liraglutide
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Insulin Secretion-Sensitivity Index (IS-SI) [84 weeks of treatment]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0020854	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. Elkind-Hirsch KE, Journal of diabetes and its complications	2020	Randomized trial	PMID 32046931 DOI	cites ClinicalTrials.gov:NCT01234649; registry reference DERIVED:32046931