GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes
NCT00229710 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270
Last updated 2010-11-19
Summary
This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Tesaglitazar
0.5 in combination with insulin (with or without other oral antidiabetic drugs)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AstraZeneca Galida Medical Science Director, MD · AstraZeneca
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-02-28
- Primary Completion
- 2006-12-31
- Completion
- 2006-12-31
Countries
- United States
Study Locations
More Related Trials
-
GALLANT 8 Tesaglitazar Add-on to Metformin
NCT00251953 ·Status: TERMINATED ·Phase: PHASE3
-
GALLANT 4 Tesaglitazar vs. Glibenclamide
NCT00255541 ·Status: TERMINATED ·Phase: PHASE3
-
GALLANT 2 Tesaglitazar vs. Placebo
NCT00252772 ·Status: TERMINATED ·Phase: PHASE3
-
GALLANT 7 Tesaglitazar Add-on to Sulphonylurea
NCT00251940 ·Status: TERMINATED ·Phase: PHASE3
-
GALLANT 6 Tesaglitazar vs. Pioglitazone
NCT00214565 ·Status: TERMINATED ·Phase: PHASE3
-
GALLANT 5 Tesaglitazar Versus Metformin
NCT00214591 ·Status: TERMINATED ·Phase: PHASE3
-
GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
NCT00280865 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of Exenatide Once Weekly Suspension in Subjects With Type 2 Diabetes
NCT01652716 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
NCT00308139 ·Status: COMPLETED ·Phase: PHASE3
-
Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
NCT00962065 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
NCT00111540 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
NCT00603239 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes
NCT00241423 ·Status: COMPLETED ·Phase: PHASE2
-
24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine
NCT00975286 ·Status: COMPLETED ·Phase: PHASE3
-
Addition Of Exenatide To Insulin Glargine In Type 2 Diabetes Mellitus
NCT00765817 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
NCT00658021 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
NCT00641056 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects
NCT00917267 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)
NCT00877890 ·Status: COMPLETED ·Phase: PHASE3
-
Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
NCT01632163 ·Status: COMPLETED ·Phase: PHASE3
-
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Basal Insulin
NCT00715624 ·Status: COMPLETED ·Phase: PHASE3
-
An Exploratory Study of the Effect of Treatment Interruption on Safety of Exenatide in Patients With Type 2 Diabetes
NCT00516048 ·Status: COMPLETED ·Phase: PHASE3
-
A Multiple-Ascending Dose Study in Type 2 Diabetes Mellitus Patients
NCT01253278 ·Status: COMPLETED ·Phase: PHASE1
-
Comparing Exenatide and Insulin Glargine in Type 2 Diabetes Patients for Whom Insulin is the Next Appropriate Therapy
NCT00099619 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes
NCT02020616 ·Status: TERMINATED ·Phase: PHASE1/PHASE2