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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: sitagliptin phosphate

• Registration Number: NCT00305604
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-08
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-22
• Primary Completion: 2008-03-12
• Study Completion: 2008-03-12
• Results First Submitted: 2009-02-24
• Results First Submitted QC: 2009-03-19
• Results First Posted: 2009-05-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	sitagliptin phosphate	sitagliptin

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24	Baseline and Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week	Week 1	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.