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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: March 20, 2006
Last updated: April 5, 2017
Last verified: April 2017
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.

Condition Intervention Phase
Type 2 Diabetes
Drug: sitagliptin phosphate
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline at Week 24 is defined as Week 24 minus Week 0.

Secondary Outcome Measures:
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Enrollment: 206
Actual Study Start Date: March 8, 2006
Study Completion Date: March 12, 2008
Primary Completion Date: March 12, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Placebo Comparator: 2
Drug: Comparator: Placebo
sitagliptin matching placebo for up to a 24-wk treatment period.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00305604

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00305604     History of Changes
Other Study ID Numbers: 0431-047
Study First Received: March 20, 2006
Results First Received: February 24, 2009
Last Updated: April 5, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017