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

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Woman's
Study ID
NCT01234649
Phase
PHASE3
Status
Completed

Conditions

  • Disorder of Glucose Regulation
  • Gestational Diabetes Mellitus
  • Impaired Glucose Tolerance
  • Metabolic Syndrome
  • Type 2 Diabetes Mellitus

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Metformin XR plus placebo — DRUG
    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
  • Metformin XR plus liraglutide — DRUG
    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)

Study Details

A diagnosis of gestational diabetes mellitus (GDM)has significant implications for the future health of the mother. GDM is often the culmination of years of unrecognized and unmodified diabetes risk factors that lead to overt and occult clinical manifestations during pregnancy. Systematic reviews of older studies conclude that 35-60% women with gestational diabetes will develop type 2 diabetes (DM2) at rates much greater than control groups who did not have glucose intolerance during pregnancy. Liraglutide may potentially delay disease progression in GDM considering the beta -(ß-)cell function improvement in DM2 and ß-cell mass shown to increase in animal models. This study will examine if the addition of liraglutide to metformin therapy is more effective than metformin alone in improving insulin sensitivity and normalizing insulin secretion in at-risk overweight/obese women with prior GDM.

Key Dates

Start date
Aug 11, 2011
Status verified
Jul 2019
Primary completion
Apr 24, 2019
Completion
Jun 14, 2019

Study Design

Enrollment
153 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Metformin XR plus liraglutide
    Metformin XR plus Liraglutide Metformin extended release (XR) 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid- 84 weeks (end study) Liraglutide - start .6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated
  • Active Comparator: 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 -84 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Woman's HospitalBaton RougeLouisiana70815-

Find similar trials in Baton Rouge, LA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Woman's Hospital· Baton Rouge, LA

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