Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Sitagliptin/Metformin FDC (Drug); Comparator: Glimepiride (Drug); Matching placebo to Sitagliptin/Metformin FDC (Drug); Matching placebo to glimepiride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (JanumetŪ),
MK-0431A) compared with the effect of glimepiride on hemoglobin A1c (HbA1c). The primary
hypothesis is that after 30 weeks, sitagliptin/metformin FDC 50/1000 mg provides superior
reduction in HbA1c (mean change from baseline) compared to glimepiride.
Clinical Details
Official title: A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (JanumetŪ) Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30Number of Participants Who Experienced at Least One Adverse Event (AE) Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Secondary outcome: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30Percentage of Participants With One or More Episodes of Hypoglycemia Change From Baseline in Body Weight at Week 30 Percentage of Participants With HbA1C < 7.0% at Week 30
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Has type 2 diabetes mellitus
- Is currently not on an anti-hypoglycemic agent (AHA) (off for at least 12 weeks) and
has a Visit 1/Screening Visit HbA1c greater than or equal to 7. 0% and less than or
equal to 9. 5%; or is currently on AHA monotherapy or low-dose oral combination
therapy (i. e., less than or equal to 50% maximum labeled dose of each agent) and has
a Visit 1/Screening Visit HbA1c greater than or equal to 6. 5% and less than or equal
to 9. 0%
Exclusion Criteria:
- Has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Has been on any investigational or approved glucagon-like peptide-1 (GLP-1) analogue
(such as exenatide, liraglutide, etc.), any investigational or approved dipeptidyl
peptidase IV (DPP-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, etc.)
or a peroxisome proliferator-activated receptor (PPAR) gamma agonist agent (such as
rosiglitazone, pioglitazone, etc.) within 12 weeks of Visit 1
- Required insulin within the prior 12 weeks
- Has a hypersensitivity or contraindication to any sulfonylurea medication (such as
glimepiride, glipizide, etc.), DPP-4 inhibitor (such as sitagliptin, vildagliptin,
alogliptin, etc.), or biguanide medication (such as metformin, etc.)
- Has inadequately controlled hypertension
- Has cirrhosis or active liver disease
- Has severe cardiac conditions
- Is obese
- Has human immunodeficiency virus (HIV)
Locations and Contacts
Additional Information
Starting date: May 2010
Last updated: August 20, 2015
|