Phase 3
Completed N=213
Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control
Source: ClinicalTrials.gov NCT00918879 ↗Enrolled (actual)
213
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcomePrimary: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) — 8.33; 8.33; 7.82; 8.28 percent — p=0.0011
Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients with inadequate glycaemic control with diet and exercise.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) |
8.33; 8.33; 7.82; 8.28; -0.51; -0.05 | 0.0011 sig |
| SECONDARY Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) |
8.37; 8.40; 7.80; 8.38; -0.58; -0.00 | 0.0623 |
| SECONDARY Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24 |
22.1; 13.3 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with Type 2 diabetes
- Patients should be drug naïve ie, not received medical treatment for diabetes
- HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)
Exclusion Criteria
- Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
- Type 1 diabetes, history of ketoacidosis or hyperosmolar non-ketonic koma
Data sourced from ClinicalTrials.gov (NCT00918879). 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.