Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)

NCT ID: NCT00767000

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 813 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.

Detailed Description

This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-0941 10 mg

Group Type: EXPERIMENTAL

MK-0941

Intervention Type: DRUG

MK-0941 tablets three times daily

Lantus

Intervention Type: BIOLOGICAL

Lantus injection once daily

Metformin

Intervention Type: DRUG

Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.

MK-0941 20 mg

Group Type: EXPERIMENTAL

MK-0941

Intervention Type: DRUG

MK-0941 tablets three times daily

Lantus

Intervention Type: BIOLOGICAL

Lantus injection once daily

Metformin

Intervention Type: DRUG

Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.

MK-0941 30 mg

Group Type: EXPERIMENTAL

MK-0941

Intervention Type: DRUG

MK-0941 tablets three times daily

Lantus

Intervention Type: BIOLOGICAL

Lantus injection once daily

Metformin

Intervention Type: DRUG

Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.

MK-0941 40 mg

Group Type: EXPERIMENTAL

MK-0941

Intervention Type: DRUG

MK-0941 tablets three times daily

Lantus

Intervention Type: BIOLOGICAL

Lantus injection once daily

Metformin

Intervention Type: DRUG

Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

Matching placebo to MK-0941 three times daily

Lantus

Intervention Type: BIOLOGICAL

Lantus injection once daily

Metformin

Intervention Type: DRUG

Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.

Interventions

MK-0941

MK-0941 tablets three times daily

Intervention Type: DRUG

Comparator: Placebo

Matching placebo to MK-0941 three times daily

Intervention Type: DRUG

Lantus

Lantus injection once daily

Intervention Type: BIOLOGICAL

Metformin

Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.

Intervention Type: DRUG

Other Intervention Names

Insulin glargine injection

Eligibility Criteria

Inclusion Criteria

• has type 2 diabetes mellitus
• has body mass index >20 and <43 kg/m^2
• is a male, or a female who is unlikely to conceive
• currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus

• completed the base study either on double-blind study medication or as part of the post-treatment follow up population
• had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period

Exclusion Criteria

• has any history of Type 1 diabetes mellitus or ketoacidosis
• has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
• has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
• is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
• has undergone surgery within 30 days prior to Visit 1 or has planned major surgery

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Meininger GE, Scott R, Alba M, Shentu Y, Luo E, Amin H, Davies MJ, Kaufman KD, Goldstein BJ. Effects of MK-0941, a novel glucokinase activator, on glycemic control in insulin-treated patients with type 2 diabetes. Diabetes Care. 2011 Dec;34(12):2560-6. doi: 10.2337/dc11-1200. Epub 2011 Oct 12.

Reference Type: RESULT

PMID: 21994424 (View on PubMed)

Other Identifiers

2008_557

Identifier Type: -

Identifier Source: secondary_id

0941-007

Identifier Type: -

Identifier Source: org_study_id