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

• Status: Completed
• Trial end date: 2019-06-14
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Woman's
• Collaborator: Novo Nordisk A/S
• Treatments: Glucagon-Like Peptide 1; Liraglutide; Metformin

Criteria

Inclusion Criteria:

• Adult female 18 years to 45 years of age who experienced GDM within 52 weeks of index pregnancy

• Actual BMI >25 kg/ m2

• Written consent for participation in the study

• Patient completed lactation

• Dysglycemia (impaired fasting glucose [IFG}, impaired glucose tolerance [IGT} or IFG/IGT) and/or ß-cell dysfunction postpartum requiring pharmacological intervention (except type 1 or 2 diabetes)

Exclusion Criteria:

Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2

• History of pancreatitis

• Significant cardiovascular, cerebrovascular, renal, or hepatobiliary diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology)

• Serum liver enzymes (AST and/or ALT levels) exceeding more than twice normal laboratory values

• Uncontrolled hypertension (systolic blood pressure>150 mm Hg and/or diastolic blood pressure >90 mm Hg)

• Fasting serum triglycerides ≥800 mg/dl at screening. Lipid-lowering medications must have been maintained at the same dose for 3 months prior to enrollment

• Hematological profiles considered to be clinically significant

• Cholestasis during the past pregnancy

• Presence of contradictions for GLP-1 receptor agonist or metformin administration such as allergy or hypersensitivity

• Current use of metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors or GLP-1 receptor agonist medications.

• Use of drugs known to exacerbate glucose tolerance.

• Use of prescription or over-the-counter weight-loss drugs

• Diabetes postpartum or history of diabetes or prior use of medications to treat diabetes except gestational diabetes

• Creatinine clearance less than 60 ml/min

• History or currently undergoing chemotherapy or radiotherapy for cancer

• Pregnancy planned during the coming two years

• Currently breastfeeding

• Exclusion criteria include any condition, which in the opinion of the investigator would place the subject at increased risk or otherwise make the subject unsuitable for participation in the study