Effect of SCH 497079 on Metabolic Parameters and Influence of Race/Ethnic Origin on Therapeutic Response (Study P05338)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: SCH 497079; Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673465

MK-7079-007 (Other Identifier)

P05338

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.

Full description

This study includes two parts, each part includes three consecutive 28-day treatment periods. Part 1 (to be conducted in the United States): each participant will receive the following treatments for 28 days in each of three treatment periods in an order determined by a random code: SCH 497079, or matching placebo, or metformin.

Part 2 (to be conducted in India): this part of the study will be conducted after completion of Part 1 and an analysis indicates a clinically significant decrease in blood glucose in participants with type 2 diabetes mellitus (T2DM) compared to placebo. The same procedures conducted in Part 1 will be conducted in Part 2.

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA participants)
• Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia)
• Type 2 diabetes mellitus

Exclusion criteria

• Female participants who are premenopausal or are not surgically sterilized. Participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding.
• Participants who have received insulin therapy within 6 months, prior to Day 1/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 6 patient groups

Treatment sequence 1: SCH 497079 → Placebo → Metformin

Experimental group

Description:

Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: Metformin

Drug: SCH 497079

Treatment sequence 2: Placebo → Metformin → SCH 497079

Experimental group

Description:

Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: Metformin

Drug: SCH 497079

Treatment sequence 3: Metformin → SCH 497079 → Placebo

Experimental group

Description:

Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: Metformin

Drug: SCH 497079

Treatment sequence 4: SCH 497079 → Metformin → Placebo

Experimental group

Description:

Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: Metformin

Drug: SCH 497079

Treatment sequence 5: Placebo → SCH 49709 → Metformin

Experimental group

Description:

Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: Metformin

Drug: SCH 497079

Treatment sequence 6: Metformin → Placebo → SCH 497079

Experimental group

Description:

Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks.

Treatment:

Drug: Placebo

Drug: Metformin

Drug: SCH 497079