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Completed

NCT Number: NCT00993187

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

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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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sitagliptin/Metformin FDC

Drug

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

Other names: Janumet®

Comparator: glimepiride

Drug

Glimepiride tablet orally up to 6 mg daily for 30 Weeks

Other names: Amaryl®

Matching placebo to Sitagliptin/Metformin FDC

Drug

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

Matching placebo to glimepiride

Drug

Matching placebo to glimepiride tablet orally daily for 30 weeks

Primary outcomes

  1. Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30

    Time frame: Baseline and Week 30

    HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 30 weeks of therapy (i.e., A1C at Week 30 minus A1C at baseline).

  2. Number of Participants Who Experienced at Least One Adverse Event (AE)

    Time frame: Up to 32 weeks

    An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.

  3. Number of Participants Who Discontinued Study Drug Due to an Adverse Event

    Time frame: Up to 30 weeks

    An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30

    Time frame: Baseline and Week 30

    Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at baseline).

  2. Percentage of Participants With One or More Episodes of Hypoglycemia

    Time frame: Up to Week 30

    Symptomatic episodes assessed as likely to be due to hypoglycemia were reported by investigators as adverse experiences of hypoglycemia. Adverse experiences of hypoglycemia were based on all reports of hypoglycemia; a concurrent glucose measurement was not required.

  3. Change From Baseline in Body Weight at Week 30

    Time frame: Baseline and Week 30

    Change in body weight following 30 weeks of therapy (i.e., body weight at Week 30 minus body weight at baseline)

  4. Percentage of Participants With HbA1C < 7.0% at Week 30

    Time frame: Week 30

    HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%).

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Randomized, Double Blind Study to Compare the Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (Janumet®) Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 12, 2009
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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