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Clinical Trial Details

Trial ID: L5420
Source ID: NCT01234649
Associated Drug: Metformin Xr Plus Placebo
Title: Combined Liraglutide and Metformin Therapy in Women With Previous Gestational Diabetes Mellitus (GDM)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01234649/results
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
Outcome Measures: Primary: Insulin Secretion-Sensitivity Index (IS-SI), IS-SI in liraglutide-metformin (LIRA-MET) therapy compared to metformin alone (PLacebo-MET), 84 weeks of treatment | Secondary: Fasting Blood Glucose (FBG), Fasting glucose levels in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Mean Glucose During OGTT (MBG), MBG derived from average glucose measured during OGTT in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), HOMA-IR, a measure of insulin resistance derived from fasting values, in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Matsuda Insulin Sensitivity Index Derived From OGTT, OGTT- derived insulin sensitivity index in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Insulinogenic Index (IGI) /HOMA-IR, IGI/HOMA-IR, a measure of early insulin response corrected by fasting insulin resistance, in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Absolute Body Weight, Body weight in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Change in Body Weight From Baseline to End of Study (Expressed as % Compared to Baseline), 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., Change from baseline (time 0) to study end (84 weeks)|Body Mass Index (BMI), BMI, a measure of total body adiposity, in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Waist Circumference (WC), Waist size (measure of truncal adiposity) with LIRA-MET compared to PL-MET, 84 weeks of treatment|Waist-to-Hip Ratio (WHR), Waist circumference divided by hip circumference (a measure of central adiposity) in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Waist to Height Ratio (WHtR), Waist circumference divided by height (measure of body fat distribution) in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Total Cholesterol (CHOL) Levels, CHOL levels in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|High Density Lipoprotein Cholesterol (HDL-C) Levels, HDL-C levels in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Low Density Lipoprotein Cholesterol (LDL-C) Levels, LDL-Cholesterol levels in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Triglyceride (TRG) Levels, TRG concentrations in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Triglyceride to High Density Lipoprotein Cholesterol Ratio TRG/HDL-C), TRG/HDL-Cholesterol levels in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Systolic Blood Pressure, SBP in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Diastolic Blood Pressure, DBP in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Alanine Aminotransferase (ALT) Levels, Hepatic enzyme, ALT, associated with insulin resistance, in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Aspartate Aminotransferase (AST), The hepatic marker, AST, associated with insulin resistance in LIRA-MET group compared with PL-MET group, 84 weeks of treatment|Alanine Aminotransferase /Aspartate Aminotransferase (ALT/AST) Ratio, ALT/AST ratio, used to assess liver function in LIRA-MET group compared with PL-MET group, 84 weeks of treatment
Sponsor/Collaborators: Sponsor: Woman's | Collaborators: Novo Nordisk A/S
Gender: FEMALE
Age: ADULT
Phases: PHASE3
Enrollment: 153
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2011-08-11
Completion Date: 2019-06-14
Results First Posted: 2019-07-26
Last Update Posted: 2019-07-26
Locations: Woman's Hospital, Baton Rouge, Louisiana, 70815, United States
URL: https://clinicaltrials.gov/show/NCT01234649