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Phase 3 Completed N=93 Randomized Quadruple-blind Treatment

Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

Type 2 Diabetes
Source: ClinicalTrials.gov NCT00918138 ↗
Enrolled (actual)
93
Serious AEs
1.1%
Results posted
Oct 2011
Primary outcomePrimary: Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4 — 191.3; 192.0; 173.2; 184.2 mg/dL — p=0.1278

Summary

The purpose of this study was to compare effect of Saxagliptin as add-on to Metformin on 24-hour mean weighted glucose (MWG) to the effect of uptitrating Metformin in subjects with T2DM inadequately controlled on metformin alone.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4		 191.3; 192.0; 173.2; 184.2; -19.0; -8.2 0.1278
SECONDARY
Change From Baseline to Week 4 in 2-hour Postprandial Glucose (PPG) (2 Hours After the Evening Meal)		 229.7; 234.0; 195.3; 228.1; -31.4; -0.2 —
SECONDARY
Change From Baseline Fasting Plasma Glucose (FPG) at Week 4, Obtained Immediately Before the Morning Meal		 162.9; 164.2; 155.2; 161.8; -9.3; -3.6 —

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetes
  • 18-78 years of age
  • Taking stable dose of metformin immediate release (IR) or XR ≥850 mg and ≤1500 mg as monotherapy for at least 8 weeks prior to screening
  • Glycosylated hemoglobin A1C (A1C) 7.5-11.5% at screening
  • Fasting C-peptide: ≥1.0 ng/mL
  • FPG≥126 mg/dl obtained at the Day -7 visit
  • Body mass index (BMI): ≤ 40kg/m²
  • A1C ≥ 7.0% and ≤ 11.0% obtained at the Day -7 visit for randomization

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 (NCT00918138). 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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