Phase 3
Completed N=206
Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)
Source: ClinicalTrials.gov NCT00305604 ↗Enrolled (actual)
206
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24 — -0.47; 0.23 Percent — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24 |
-0.47; 0.23 | <0.001 sig |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 |
-16.2; 10.6 | <0.001 sig |
| SECONDARY Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 |
-52.1; 8.9 | <0.001 sig |
| SECONDARY Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week |
-25.7; -2.1 | <0.001 sig |
Eligibility Criteria
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 260 mg/dL
- Poorly controlled hypertension
Data sourced from ClinicalTrials.gov (NCT00305604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.