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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: MK-0893; Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02004886

0893-005

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 4 patient groups, including a placebo group

MK-0893 (40 mg)

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: MK-0893

MK-0893 (120 mg)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo

Drug: MK-0893

Metformin (2000 mg)

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Metformin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo