Phase 3
Completed N=565
A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone
Source: ClinicalTrials.gov NCT00295633 ↗Enrolled (actual)
565
Serious AEs
10.1%
Results posted
Sep 2009
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 — 8.25; 8.35; 8.19; 7.59 percent
Summary
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) at Week 24 |
8.25; 8.35; 8.19; 7.59; 7.39; 7.91 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
163.0; 159.5; 162.4; 148.2; 143.0; 159.3 | — |
| SECONDARY Percentage of Participants Achieving A1c <7% at Week 24 |
42.2; 41.8; 25.6 | — |
| SECONDARY Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 |
48301; 47866; 47256; 40255; 38587; 44819 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
- Hemoglobin A1c (HbA1c) > = 7.0% and = 1 ng/mL
Exclusion Criteria
- Symptomatic poorly controlled diabetes
- Recent cardiac or cerebrovascular event
- Serum creatinine > = 2.0 mg/dL
Data sourced from ClinicalTrials.gov (NCT00295633). 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.