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

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00824616
• Other study ID #: 0941-018
• Secondary ID: 2009_516MK-0941-
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2009
• Last updated: July 21, 2015
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MK-0941
MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.
• Placebo
Placebo tablets, taken 3 times daily.
• Insulin
Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c) Level	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.	Baseline (Day 1) and End of Treatment (Week 20)	No
Primary	Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)	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.	From first dose of study drug (Week 0) to last dose of study drug (Week 20)	Yes