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Completed

NCT Number: NCT00824616

A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin 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

21 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

  • Participant has Type 2 Diabetes Mellitus

Exclusion criteria

  • Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis
  • Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
  • Participant has had surgery within 30 days of starting the study or has planned major surgery

Treatment and study plan

MK-0941

Drug

MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.

Placebo

Drug

Placebo tablets, taken 3 times daily.

Insulin

Drug

Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

Other names: LANTUS®

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c) Level

    Time frame: Baseline (Day 1) and End of Treatment (Week 20)

    HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.

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

    Time frame: From first dose of study drug (Week 0) to last dose of study drug (Week 20)

    Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 19, 2009
Registry last updated
Jul 28, 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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