Phase 3 Completed N=160 Randomized Quadruple-blind Treatment

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT00885378 ↗

Enrolled (actual)

160

Serious AEs

1.3%

Results posted

Dec 2011

Primary outcomePrimary: Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 — 7.92; 7.97; -0.56; -0.22 Percentage of glycosylated hemoglobins — p=0.0063

Summary

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12	7.92; 7.97; -0.56; -0.22	0.0063 sig
SECONDARY Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG)	164.22; 161.25; -13.73; -4.22	0.1248
SECONDARY Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12	37.5; 24.2	—
SECONDARY Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12	24.6; 10.7	—

Eligibility Criteria

Inclusion Criteria

Type 2 diabetes
18-78 years of age
Taking stable twice daily (BID) dosing of metformin IR (at least 1500 mg) for at least 8 weeks
A1C: 7-10%
C-peptide: ≥ 0.8 ng/mL
Body mass index (BMI): ≤45 kg/m^2

Exclusion Criteria

Women of childbearing potential unable or unwilling to use acceptable birth control
Women who are pregnant or breastfeeding
Fasting plasma glucose (FPG) >270 mg/dL
Significant cardiovascular history
Symptoms of poorly controlled diabetes
History of diabetic ketoacidosis or hyperosmolar nonketotic coma
Insulin therapy within one year of screening
Cardiovascular even within the prior 6 months
New York Heart Association Stage III/IV congestive heart failure and/or known left ventricular ejection fraction <=40%
Significant history of renal or hepatic disease
History of a psychiatric disorder, alcohol or drug abuse within the previous year
Treatment with potent CYP3A4 inhibitors or inducers
Immunocompromised participants
Active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests

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Data sourced from ClinicalTrials.gov (NCT00885378). 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.