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Study of Sitagliptin in Older Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00305604
First received: March 20, 2006
Last updated: April 20, 2010
Last verified: April 2010
History of Changes

March 20, 2006
April 20, 2010
March 2006
March 2008   (final data collection date for primary outcome measure)
Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
HbA1c, Fasting Plasma glucose at 24 weeks
Complete list of historical versions of study NCT00305604 on ClinicalTrials.gov Archive Site
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    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.
Overall safety and tolerability, fasting plasma glucose, and 2-hr post prandial glucose at 24 weeks; rapidity of onset of action as determined by home glucose monitoring after 1 week of therapy.
Not Provided
Not Provided
 
Study of Sitagliptin in Older Type 2 Diabetics
A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • 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.
    Other Name: MK0431
  • Drug: Comparator: Placebo
    sitagliptin matching placebo for up to a 24-wk treatment period.
  • Active Comparator: 1
    sitagliptin
    Intervention: Drug: sitagliptin phosphate
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Comparator: Placebo
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-blind, placebo-controlled trial. Curr Med Res Opin. 2011 May;27(5):1049-58. Epub 2011 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00305604
2006_003, MK0431-047
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP