Phase 3
Completed N=170
Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
Source: ClinicalTrials.gov NCT00614939 ↗Enrolled (actual)
170
Serious AEs
27.7%
Results posted
Jul 2010
Primary outcomePrimary: Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) — 8.09; 8.45; 7.80; 7.63 Percent — p=0.007
Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) |
8.09; 8.45; 7.80; 7.63; -0.44; -0.86 | 0.007 sig |
| SECONDARY Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup |
162.33; 202.82; 174.50; 173.91; -2.88; -15.22 | 0.339 |
| SECONDARY Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup |
9.63; 9.17; 7.86; 7.43; -1.66; -1.89 | — |
| SECONDARY Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup |
9.46; 9.83; 8.94; 11.52; -0.62; 1.81 | — |
| SECONDARY Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup |
9.01; 11.25; 9.68; 9.65; -0.16; -0.84 | — |
| SECONDARY Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52 |
8.10; 8.44; 7.93; 7.41; -0.53; -1.35 | — |
| SECONDARY Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup |
9.01; 11.25; 9.70; 9.85; 0.15; -0.82 | — |
| SECONDARY Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup |
9.63; 9.17; 8.42; 7.71; -1.37; -2.25 | — |
| SECONDARY Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup |
9.46; 9.83; 8.99; 11.89; -0.11; -2.25 | — |
| SECONDARY Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup |
9.01; 11.25; 9.70; 9.85; 0.15; -0.82 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes
- Documented history of CrCl <50 ml/min within the 3 months prior to enrollment
- HbA1c ≥7.0% and ≤11.0%
Exclusion Criteria
- Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
- Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.
Data sourced from ClinicalTrials.gov (NCT00614939). 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.