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Completed

NCT Number: NCT00295633

A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Belgrano, Buenos Aires, Argentina

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About this study

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 (defined as rescue medication) added onto their blinded study medication

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetics currently receiving a stable dose of TZD monotherapy (pioglitazone 30mg or 45mg, or rosiglitazone 4mg or 8mg) for at least 12 weeks prior to screening.
  • Hemoglobin A1c (HbA1c) > = 7.0% and < = 10.5%
  • Body mass index < = 45kg/m2
  • Fasting C-peptide > = 1 ng/mL

Exclusion criteria

  • Symptomatic poorly controlled diabetes
  • Recent cardiac or cerebrovascular event
  • Serum creatinine > = 2.0 mg/dL

Treatment and study plan

Saxagliptin

Drug

Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT)

Other names: BMS-477118

Placebo

Drug

Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT)

pioglitazone

Drug

Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT)

rosiglitazone

Drug

Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT)

metformin

Drug

Tablets, Oral, 500-2500 mg, as needed (12 months LT)

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (A1C) at Week 24

    Time frame: Baseline, Week 24

    Mean change from baseline in A1C at Week 24, adjusted for baseline value.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Time frame: Baseline, Week 24

    Mean change from baseline in FPG at Week 24, adjusted for baseline value.

  2. Percentage of Participants Achieving A1c <7% at Week 24

    Time frame: Week 24

    Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24.

  3. Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24

    Time frame: Baseline, Week 24

    Mean change from baseline for 0 to 180 minutes PPG AUC achieved at each dose of saxagliptin plus TZD versus placebo plus TZD at Week 24, adjusted for baseline value.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Feb 24, 2006
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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