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Phase 3 Completed N=93 Randomized Double-blind Treatment

Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

Type 2 Diabetes
Source: ClinicalTrials.gov NCT00683657 ↗
Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4 — 177.5; 181.2; 163.8; 184.2 mg/dL — p=0.0001

Summary

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4		 177.5; 181.2; 163.8; 184.2; -13.8; 3.0 0.0001 sig
SECONDARY
Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4		 212.1; 211.1; 181.4; 210.8; -30.7; -0.4 <0.0001 sig
SECONDARY
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4		 237.6; 233.1; 198.5; 231.1; -38.2; -2.8 0.0010 sig
SECONDARY
Change From Baseline in Mean Daily Glucose at Week 4		 179.0; 184.9; 167.5; 191.8; -11.7; 7.0 <0.0001 sig
SECONDARY
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4		 152.2; 158.9; 141.9; 162.9; -10.8; 4.5 0.0002 sig

Eligibility Criteria

Inclusion Criteria

  • ≥18- and ≤77-years-old
  • Type 2 diabetes
  • Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
  • Glycosylated hemoglobin (A1C) ≥7% and ≤10%
  • Body mass index (BMI) ≤40 kg/m2

Exclusion Criteria

  • Women of childbearing potential unable or unwilling to use acceptable birth control
  • Women who are pregnant or breastfeeding
  • Significant cardiovascular history
  • Active liver disease
  • Renal impairment
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00683657). 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.

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