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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Saxagliptin; Drug: Placebo matching Saxagliptin; Drug: Placebo matching Metformin; Drug: Metformin

• Registration Number: NCT00121641
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise

Detailed Description

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) \> 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-15
• Study First Submitted QC: 2005-07-15
• Study First Posted: 2005-07-21
• Primary Completion: 2006-08
• Disposition First Submitted: 2009-07-30
• Disposition First Submitted QC: 2009-11-12
• Study Completion: 2010-02
• Disposition First Posted: 2010-03-04
• Results First Submitted: 2011-04-12
• Results First Submitted QC: 2011-04-12
• Results First Posted: 2011-05-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1035

Inclusion Criteria

• Type 2 diabetes mellitus
• Drug naive
• Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm)
• Fasting C-peptide >= 1 ng/mL
• Body mass index <= 40 kg/m2

Exclusion Criteria

• Symptomatic poorly controlled diabetes
• Recent cardiac or cerebrovascular event
• Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing Potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saxagliptin 2.5 mg (A)	Saxagliptin	Metformin 500-2000 mg (as needed for rescue)
Saxagliptin 2.5 mg (A)	Placebo matching Metformin	Metformin 500-2000 mg (as needed for rescue)
Saxagliptin 2.5 mg (A)	Metformin	Metformin 500-2000 mg (as needed for rescue)
Saxagliptin 5 mg (B)	Saxagliptin	Metformin 500-2000 mg (as needed for rescue)
Saxagliptin 5 mg (B)	Placebo matching Metformin	Metformin 500-2000 mg (as needed for rescue)
Saxagliptin 5 mg (B)	Metformin	Metformin 500-2000 mg (as needed for rescue)
Saxagliptin 10 mg (C)	Saxagliptin	Metformin 500-2000 mg (as needed for rescue)
Saxagliptin 10 mg (C)	Placebo matching Metformin	Metformin 500-2000 mg (as needed for rescue)
Saxagliptin 10 mg (C)	Metformin	Metformin 500-2000 mg (as needed for rescue)
Placebo (D)	Placebo matching Saxagliptin	Metformin 500-2000 mg (as needed for rescue)
Open-Label Treatment Cohort (Direct Enrollees) (E)	Metformin	Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)
Placebo (D)	Metformin	Metformin 500-2000 mg (as needed for rescue)
Open-Label Treatment Cohort (Direct Enrollees) (E)	Saxagliptin	Saxagliptin 10 mg Metformin 500-2000 mg (as needed for rescue)

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c (A1C) Changes From Baseline at Week 24	Baseline, Week 24	To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.
A1C Changes From Baseline at Week 24 - Open Label Cohort	Baseline, Week 24	To compare the change from baseline in HbA1c achieved with each dose of saxagliptin versus placebo in treatment naive subjects with type 2 diabetes who have inadequate glycemic control defined as A1C ≥7.0% and ≤10.0%.

Secondary Outcome Measures

Name	Time	Method
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG)	Baseline, Week 24
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24	Week 24
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC)	Baseline, Week 24
Baseline and Change From Baseline at Week 24 in Fasting Plasma Glucose (FPG) - Open Label Cohort	Baseline, Week 24
Percentage of Participants Achieving Therapeutic Glycemic Response (A1C < 7.0%) at Week 24 - Open Label Cohort	Week 24
Baseline and Change From Baseline at Week 24 in Postprandial Glucose (PPG) Area Under the Curve (AUC) - Open Label Cohort	Baseline, Week 24

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Taipei, Taiwan