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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: sitagliptin phosphate
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>sitagliptin | Drug: sitagliptin phosphate<br>* 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.<br>* Other names: MK0431;|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo<br>* sitagliptin matching placebo for up to a 24-wk treatment period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24 | Change from baseline at Week 24 is defined as Week 24 minus Week 0. | Baseline and Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Week 1 |