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

PHASE3CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

August 11, 2011

Primary Completion Date

April 24, 2019

Study Completion Date

June 14, 2019

Conditions
Gestational Diabetes MellitusType 2 Diabetes MellitusMetabolic SyndromeImpaired Glucose ToleranceDisorder of Glucose Regulation
Interventions
DRUG

Metformin XR plus placebo

Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -98 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated

DRUG

Metformin XR plus liraglutide

Metformin XR-500 qd for 2 weeks, 500 mg bid 2 weeks; 500 mg am, 1000 mg pm- 2 weeks - 1000 bid final dose Liraglutide- start 0.6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated during the 4-wk non-forced dose-escalation period ( maximum allowed dose of 1.8 mg SC QD)

Trial Locations (1)

70815

Woman's Hospital, Baton Rouge

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

lead

Woman's

OTHER