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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Saxagliptin; Drug: Placebo; Drug: pioglitazone; Drug: rosiglitazone; Drug: metformin

• Registration Number: NCT00295633
• Lead Sponsor: AstraZeneca

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2006-02-22
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-24
• Study Start: 2006-03
• Primary Completion: 2007-10
• Study Completion: 2008-10
• Results First Submitted: 2009-08-17
• Results First Submitted QC: 2009-08-17
• Results First Posted: 2009-09-25
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saxagliptin plus open-label TZD (B)	Saxagliptin	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Placebo plus open-label TZD (C)	Placebo	Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Placebo plus open-label TZD (C)	rosiglitazone	Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Placebo plus open-label TZD (C)	metformin	Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin plus open-label TZD (A)	Saxagliptin	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin plus open-label TZD (A)	pioglitazone	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin plus open-label TZD (A)	metformin	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin plus open-label TZD (A)	rosiglitazone	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin plus open-label TZD (B)	pioglitazone	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin plus open-label TZD (B)	metformin	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Saxagliptin plus open-label TZD (B)	rosiglitazone	Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Placebo plus open-label TZD (C)	pioglitazone	Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Baseline, Week 24	Mean change from baseline in FPG at Week 24, adjusted for baseline value.
Percentage of Participants Achieving A1c <7% at Week 24	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.
Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24	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.

Trial Locations

Locations (80)

Winston Technology, Inc.; 🇺🇸 Haleyville, Alabama, United States

Sunbelt Research Group, Llc; 🇺🇸 Mobile, Alabama, United States

Iicr, Inc.; 🇺🇸 Ozark, Alabama, United States

Clinical Research Advantage, Inc; 🇺🇸 Mesa, Arizona, United States

Nea Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Little Rock Family Practice Clinic; 🇺🇸 Little Rock, Arkansas, United States

Impact Clinical Trials; 🇺🇸 Beverly Hills, California, United States

Lovelace Scientific Resources, Inc.; 🇺🇸 Beverly Hills, California, United States

Medical Group Of Encino; 🇺🇸 Encino, California, United States

Marin Endocrine Care And Research, Inc.; 🇺🇸 Greenbrae, California, United States

Scroll for more (70 remaining)