A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)

NCT ID: NCT02004886

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-11
• Study Completion Date: 2007-02-07

Brief Summary

This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.

Conditions

Type 2 Diabetes Mellitus

Study Design

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

Study Groups

MK-0893 (40 mg)

MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893.

Group Type: EXPERIMENTAL

MK-0893

Intervention Type: DRUG

10 mg and 100 mg tablets

Placebo

Intervention Type: DRUG

Placebo tablets matching MK-0893

Placebo

Intervention Type: DRUG

Placebo tablets matching metformin

MK-0893 (120 mg)

MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893

Group Type: EXPERIMENTAL

MK-0893

Intervention Type: DRUG

10 mg and 100 mg tablets

Placebo

Intervention Type: DRUG

Placebo tablets matching MK-0893

Placebo

Intervention Type: DRUG

Placebo tablets matching metformin

Metformin (2000 mg)

Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

500 mg metformin tablets

Placebo

Intervention Type: DRUG

Placebo tablets matching MK-0893

Placebo

Placebo tablets matching the MK-0893 and placebo tablets matching metformin.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets matching MK-0893

Placebo

Intervention Type: DRUG

Placebo tablets matching metformin

Interventions

MK-0893

10 mg and 100 mg tablets

Intervention Type: DRUG

Metformin

500 mg metformin tablets

Intervention Type: DRUG

Placebo

Placebo tablets matching MK-0893

Intervention Type: DRUG

Placebo

Placebo tablets matching metformin

Intervention Type: DRUG

Other Intervention Names

Glucophage; Glucophage XR; Glumetza; Fortamet; Riomet

Eligibility Criteria

Inclusion Criteria

• Type 2 diabetes
• Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones [i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents])
• male or a female of non-childbearing potential. Women must be postmenopausal or premenopausal and documented surgically sterilized
• A body mass index (BMI) that is > 20 and ≤ 40 kg/m2

Exclusion Criteria

• History of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
• History of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
• Treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
• oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
• History of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
• History of gastrointestinal problems or disorders or extensive bowel or gastric surgery
• History of significant or unstable cardiovascular disease
• History of neoplastic disease
• History of hepatic disease
• History of seizures, epilepsy or other neurologic disease
• History of myelodysplastic or pre-leukemic disorders or other severe hematological disorder

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0893-005

Identifier Type: -

Identifier Source: org_study_id