Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: sitagliptin phosphate; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541229

2007_533

0431-077

Details and patient eligibility

About

A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg in patients with type 2 diabetes.

Enrollment: 103 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has Type 2 Diabetes
• Patient is between the ages of 30-65 years
• Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C] 7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

Exclusion criteria

• Patient has Type 1 Diabetes
• Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has been treated with exenatide in the past 3 months
• Patient has taken insulin within the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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103 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

sitagliptin 100 mg

Treatment:

Drug: sitagliptin phosphate

Drug: sitagliptin phosphate

2

Experimental group

Description:

sitagliptin 200 mg

Treatment:

Drug: sitagliptin phosphate

Drug: sitagliptin phosphate

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo