Phase 3 Completed N=36 Randomized Double-blind Treatment

A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

Source: ClinicalTrials.gov NCT00374907 ↗

Enrolled (actual)

Serious AEs

8.3%

Results posted

Jan 2011

Primary outcomePrimary: Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12 — 15.9; -2.2 Percent Change (Percentage of Baseline) — p=0.0350

Summary

The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

Outcome Measures

Outcome	Result	p-value
PRIMARY Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12	15.9; -2.2	0.0350 sig
SECONDARY Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12	22.6; -4.1	0.0204 sig

Eligibility Criteria

Inclusion Criteria

Type 2 diabetes mellitus
Drug naive
Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
Fasting C-peptide ≥1.0 ng/mL
Body mass index ≤40 kg/m²

Exclusion Criteria

Recent cardiac or cerebrovascular event
Elevated serum creatinine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00374907). 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.