Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00305604

0431-047

2006_003

MK0431-047

Details and patient eligibility

About

To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.

Enrollment: 206 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
• Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit

Exclusion criteria

• Patients with type 1 diabetes
• History of ketoacidosis or requires insulin use
• Alanine aminotransferase / aspartate aminotransferase > 2.5 X ULN, triglycerides > 600 mg/dL, creatinine clearance < 35 mL/min
• Fasting plasma glucose consistently > 260 mg/dL
• Poorly controlled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

sitagliptin

Treatment:

Drug: sitagliptin phosphate

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo