Phase 3
Completed N=743
Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
Source: ClinicalTrials.gov NCT00121667 ↗Enrolled (actual)
743
Serious AEs
11.7%
Results posted
Apr 2011
Primary outcomePrimary: Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 — 8.08; 8.07; 7.98; 8.06 percentage of glycosylated hemoglobins — p=<.0001
Summary
The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 |
8.08; 8.07; 7.98; 8.06; -0.59; -0.69 | <.0001 sig |
| SECONDARY Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
173.57; 179.03; 175.86; 174.94; -14.31; -22.03 | <.0001 sig |
| SECONDARY Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 |
37.1; 43.5; 44.4; 16.6 | <.0001 sig |
| SECONDARY Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) |
48224; 49021; 44931; 47407; -8891; -9586 | <.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
- HbA1c >= 7.0% and = 1 ng/dL
Exclusion Criteria
- Symptomatic poorly controlled diabetes
- Recent cardiac or cerebrovascular event
- Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for females
Data sourced from ClinicalTrials.gov (NCT00121667). 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.