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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-04

Study Completion Date

2013-10-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sitagliptin/Metformin FDC

Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.

Group Type EXPERIMENTAL

Sitagliptin/Metformin FDC

Intervention Type DRUG

Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks

Matching placebo to glimepiride

Intervention Type DRUG

Matching placebo to glimepiride tablet orally daily for 30 weeks

Glimepiride

Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.

Group Type ACTIVE_COMPARATOR

Comparator: Glimepiride

Intervention Type DRUG

Glimepiride tablet orally up to 6 mg daily for 30 Weeks

Matching placebo to Sitagliptin/Metformin FDC

Intervention Type DRUG

Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks

Interventions

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Sitagliptin/Metformin FDC

Sitagliptin phosphate plus metformin hydrochloride combination tablet (MK-0431A) orally up to 50/1000 mg BID for 30 weeks

Intervention Type DRUG

Comparator: Glimepiride

Glimepiride tablet orally up to 6 mg daily for 30 Weeks

Intervention Type DRUG

Matching placebo to Sitagliptin/Metformin FDC

Matching placebo to Sitagliptin/Metformin FDC 50/1000 mg orally BID for 30 weeks

Intervention Type DRUG

Matching placebo to glimepiride

Matching placebo to glimepiride tablet orally daily for 30 weeks

Intervention Type DRUG

Other Intervention Names

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Janumet® Amaryl®

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No