GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin
NCT00242372 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 370
Last updated 2009-04-22
Summary
This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.
Conditions
Interventions
- DRUG
-
Tesaglitazar 0.5
- DRUG
-
Insulin at least 30 units/day
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AstraZeneca Galida Medical Sciences Director, MD · AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-08-31
- Completion
- 2006-03-31
Countries
- United States
Study Locations
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