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

Merck Sharp & Dohme LLC206 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

206

Conditions

Type 2 Diabetes

Interventions

sitagliptin phosphateDRUG

Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.

Comparator: PlaceboDRUG

sitagliptin matching placebo for up to a 24-wk treatment period.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24

Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Time frame: Baseline and Week 24

Secondary Outcomes

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24

Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Time frame: Baseline and Week 24

Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24

Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Time frame: Baseline and Week 24

Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week

Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.

Time frame: Week 1

Data from ClinicalTrials.gov

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