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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305604
• Other study ID #: 0431-047
• Secondary ID: MK0431-0472006_0
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2006
• Last updated: February 3, 2015
• Start date: March 2006
• Est. completion date: March 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• sitagliptin phosphate
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: Placebo
sitagliptin matching placebo for up to a 24-wk treatment period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Barzilai N, Guo H, Mahoney EM, Caporossi S, Golm GT, Langdon RB, Williams-Herman D, Kaufman KD, Amatruda JM, Goldstein BJ, Steinberg H. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-bli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site