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Completed

NCT Number: NCT00305604

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin phosphate

Drug

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 names: MK0431

Comparator: placebo

Drug

sitagliptin matching placebo for up to a 24-wk treatment period.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 22, 2006
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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