Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Glucose Intolerance

Treatments: Drug: Placebo for Sitagliptin 25 mg; Drug: Sitagliptin 25 mg; Drug: Placebo for Sitagliptin 50 mg; Drug: Sitagliptin 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405911

MK-0431-105 (Other Identifier)

0431-105

Details and patient eligibility

About

This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

Enrollment: 242 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Impaired glucose tolerance
• On diet/exercise therapy
• Unlikely to conceive
• Meets all of the following glycemic parameters: Hemoglobin A1c (Japan Diabetes Society value) <6.1%, Fasting Plasma Glucose <126 mg/dL, and 2-hr plasma glucose level in 75g oral glucose tolerance test ≥140 mg/dL and <200 mg/dL

Exclusion criteria

• History of diabetes mellitus
• Disease or condition of clear or likely glucose tolerance disorder
• Previously treated with a drug to prevent diabetes and/or any antihyperglycemic drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.

Treatment:

Drug: Placebo for Sitagliptin 25 mg

Drug: Placebo for Sitagliptin 50 mg

Sitagliptin 25 mg

Experimental group

Description:

Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks.

Treatment:

Drug: Sitagliptin 25 mg

Drug: Placebo for Sitagliptin 50 mg

Sitagliptin 50 mg

Experimental group

Description:

Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.

Treatment:

Drug: Sitagliptin 50 mg

Drug: Placebo for Sitagliptin 25 mg