Status:
COMPLETED
Sitagliptin + Metformin Compared to Metformin Monotherapy and Placebo in Women With a Recent GDM
Lead Sponsor:
Woman's
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Disorder of Glucose Regulation
Eligibility:
FEMALE
18-42 years
Phase:
PHASE4
Brief Summary
Gestational diabetes mellitus (GDM) is defined as "any degree of glucose intolerance with onset or first recognition during pregnancy." GDM is one of the most frequent metabolic disorders occurring du...
Detailed Description
Gestational diabetes mellitus (GDM) is defined as "any degree of glucose intolerance with onset or first recognition during pregnancy." GDM is one of the most frequent metabolic disorders occurring du...
Eligibility Criteria
Inclusion
- Females 18 years to 42 years of age who experienced gestational diabetes mellitus (GDM) during recent (within 12 months) pregnancy with prediabetic hyperglycemia determined by an oral glucose tolerance test (OGTT) with 75 g glucose postpartum. Study subjects will be inclusive of prior GDM women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) postpartum.
- Written consent for participation in the study
Exclusion
- Cholestasis during the past pregnancy
- Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology)
- Serum aspartate transaminase (AST) and/or alanine aminotransferase (ALT) level exceeding more than twice normal lab values
- Presence of hypersensitivity to sitagliptin or other DPP-4 inhibitor
- Current use of metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, or weight loss medications (prescription or over the counter \[OTC\])
- Prior use of medication to treat diabetes except gestational diabetes
- Use of drugs known to exacerbate glucose tolerance
- History of diabetes or prior use of medications to treat diabetes except GDM
- Creatinine clearance less than 60 ml/min
- Pregnancy planned during the coming two years
- Currently lactating
- Patient not willing to use adequate contraception during study period (unless sterilized)
Key Trial Info
Start Date :
September 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2017
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01856907
Start Date
September 28 2013
End Date
September 28 2017
Last Update
January 23 2018
Active Locations (1)
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1
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817