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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: metformin
Drug: Placebo
Drug: rosiglitazone
Drug: pioglitazone
Drug: Saxagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00295633
CV181-013

Details and patient eligibility

About

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

Full 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

Enrollment

565 patients

Sex

All

Ages

18 to 77 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

565 participants in 3 patient groups, including a placebo group

Saxagliptin plus open-label TZD (A)
Experimental group
Description:
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Treatment:
Drug: Saxagliptin
Drug: rosiglitazone
Drug: Saxagliptin
Drug: metformin
Drug: pioglitazone
Saxagliptin plus open-label TZD (B)
Experimental group
Description:
Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Treatment:
Drug: Saxagliptin
Drug: rosiglitazone
Drug: Saxagliptin
Drug: metformin
Drug: pioglitazone
Placebo plus open-label TZD (C)
Placebo Comparator group
Description:
Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)
Treatment:
Drug: rosiglitazone
Drug: metformin
Drug: Placebo
Drug: pioglitazone

Trial contacts and locations

133

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Data sourced from clinicaltrials.gov

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