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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Comparator: Placebo; Biological: Lantus; Drug: MK-0941; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00767000

2008_557

0941-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 813 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Extension Study Inclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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813 participants in 5 patient groups, including a placebo group

MK-0941 10 mg

Experimental group

Treatment:

Drug: MK-0941

Drug: Metformin

Biological: Lantus

MK-0941 20 mg

Experimental group

Treatment:

Drug: MK-0941

Drug: Metformin

Biological: Lantus

MK-0941 30 mg

Experimental group

Treatment:

Drug: MK-0941

Drug: Metformin

Biological: Lantus

MK-0941 40 mg

Experimental group

Treatment:

Drug: MK-0941

Drug: Metformin

Biological: Lantus

Placebo

Placebo Comparator group

Treatment:

Drug: Metformin

Biological: Lantus

Drug: Comparator: Placebo