Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone

Phase 3

Completed

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

• Registration Number: NCT00121667
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone

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 pioglitizone added onto their blinded study medication

Study Timeline

• Study First Submitted: 2005-07-18
• Study First Submitted QC: 2005-07-20
• Study First Posted: 2005-07-21
• Study Start: 2005-08
• Primary Completion: 2006-10
• Disposition First Submitted: 2009-07-30
• Study Completion: 2010-02
• Disposition First Submitted QC: 2010-08-13
• Disposition First Posted: 2010-08-18
• Results First Submitted: 2011-03-15
• Results First Submitted QC: 2011-03-15
• Results First Posted: 2011-04-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1462

Inclusion Criteria

• Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening.
• HbA1c >= 7.0% and <= 10.0 %
• Body mass index <= 40 kg/m2
• Fasting C-peptide >= 1 ng/dL

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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 females

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saxagliptin + Metformin (B)	Saxagliptin + Metformin	Pioglitazone 15-45 mg (as needed for rescue)
Saxagliptin + Metformin (A)	Saxagliptin + Metformin	Pioglitazone 15-45 mg (as needed for rescue)
Saxagliptin + Metformin (A)	Pioglitazone	Pioglitazone 15-45 mg (as needed for rescue)
Placebo+ Metformin (D)	Placebo + Metformin	Pioglitazone 15-45 mg (as needed for rescue)
Placebo+ Metformin (D)	Pioglitazone	Pioglitazone 15-45 mg (as needed for rescue)
Saxagliptin + Metformin (C)	Saxagliptin + Metformin	Pioglitazone 15-45 mg (as needed for rescue)
Saxagliptin + Metformin (C)	Pioglitazone	Pioglitazone 15-45 mg (as needed for rescue)
Saxagliptin + Metformin (B)	Pioglitazone	Pioglitazone 15-45 mg (as needed for rescue)

Primary Outcome Measures

Name	Time	Method
Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24	Baseline, Week 24	Mean change from baseline is adjusted for baseline value.

Secondary Outcome Measures

Name	Time	Method
Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline, Week 24	Mean change from baseline is adjusted for baseline value.
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	Mean change from baseline is adjusted for baseline value.

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Taipei, Taiwan