Overview

Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)

Status:
Completed
Trial end date:
2013-10-29
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the effect of sitagliptin/metformin FDC 50/1000 mg (Janumet®), 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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Glimepiride
Metformin
Sitagliptin Phosphate
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)