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Completed

NCT Number: NCT00792935

A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)

The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has type 2 diabetes mellitus
  • Between the ages of 18 and 70

Exclusion criteria

  • Patient has a history of type 1 diabetes mellitus or ketoacidosis.
  • Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
  • Patient has had surgery within 30 days of starting the study or has planned major surgery during the study

Treatment and study plan

MK-0941

Drug

MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks.

Glimepiride

Drug

Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks.

Other names: Amaryl®

metformin

Drug

The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], the participant should remain on the same metformin dose throughout the study.

Primary outcomes

  1. Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose

    Time frame: Baseline and Week 6

    Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.

  2. Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)

    Time frame: Baseline to Week 6

    Hypoglycemic episodes are defined as either a fingerstick glucose

    measurement of ≤70 mg/dL [3.9 mmol/L] with or without symptoms or symptomatic hypoglycemia.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2008
Registry last updated
Dec 17, 2015

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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