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Type 2 Diabetes clinical trials

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NCT ID: NCT00362765 Terminated - Type 2 Diabetes Clinical Trials

Fenofibrate and Metformin Insulin Sensitivity in Type 2 Diabetics Study

Start date: October 2006
Phase: Phase 2/Phase 3
Study type: Interventional

Double-blind, randomized placebo-controlled study in type 2 diabetes and dyslipidemic patients.Patients will be randomized to one of four treatment arms for 16 weeks: placebo, fenofibrate, metformin, or metformin and fenofibrate combination.

NCT ID: NCT00332085 Terminated - Type 2 Diabetes Clinical Trials

Pilot Trial of Chromium-Metformin Combination in Type 2 Diabetes

Start date: January 2006
Phase: Phase 1
Study type: Interventional

This pilot trial seeks to gather preliminary data on the combination of chromium picolinate, the most commonly used form of chromium, and metformin. The trial will recruit type 2 diabetes subjects already on metformin and treat them with chromium for 8 weeks. The results of this trial will provide vital preliminary data including safety and size of effect to direct future studies.

NCT ID: NCT00300105 Terminated - Type 2 Diabetes Clinical Trials

GALLEX 4 - Long-Term Extension Study to Evaluate Tesaglitazar Therapy in Patients With Type 2 Diabetes

Start date: October 2005
Phase: Phase 3
Study type: Interventional

This is a parallel-group, multi-center, long-term extension study from the GALLANT 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. The total duration, including treatment and follow-up, is 103 weeks.

NCT ID: NCT00263965 Terminated - Type 2 Diabetes Clinical Trials

ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity

Start date: August 2005
Phase: Phase 2
Study type: Interventional

This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.

NCT ID: NCT00261417 Terminated - Type 2 Diabetes Clinical Trials

Dose Response Study in Japanese Patients

Start date: May 2004
Phase: Phase 2
Study type: Interventional

This is a 12-week study to determine the effect on glucose and lipids, safety, and tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week follow-up.

NCT ID: NCT00261352 Terminated - Type 2 Diabetes Clinical Trials

GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Start date: March 2005
Phase: Phase 3
Study type: Interventional

This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)

NCT ID: NCT00255645 Terminated - Type 2 Diabetes Clinical Trials

G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)

Start date: September 2005
Phase: Phase 3
Study type: Observational

This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.

NCT ID: NCT00255541 Terminated - Type 2 Diabetes Clinical Trials

GALLANT 4 Tesaglitazar vs. Glibenclamide

Start date: September 2004
Phase: Phase 3
Study type: Interventional

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (glibenclamide) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week double blind treatment period and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

NCT ID: NCT00252876 Terminated - Type 2 Diabetes Clinical Trials

GALLEX 1 - Long Term Extension Study in Patients With Type 2 Diabetes

Start date: March 2005
Phase: Phase 3
Study type: Interventional

This is a 107-week open-label, multi-center long-term extension study from GALLANT studies 2/22, 5, 7, 8 and 14 to monitor the safety and tolerability of oral tesaglitazar 1 mg in patients with type 2 diabetes during up to 104 weeks of treatment. The total duration, including treatment and follow-up, is 107 weeks.

NCT ID: NCT00252837 Terminated - Type 2 Diabetes Clinical Trials

GALLANT 22 Tesaglitazar vs. Placebo

Start date: April 2005
Phase: Phase 3
Study type: Interventional

This is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6-week single-blind placebo run-in period, followed by 24-week treatment period and a 3-week follow-up period. The study design of GALLANT 2 is identical to GALLANT 22; the blinded study data from GALLANT 2 will be transferred to the GALLANT 22 database and will be analyzed together with the data from GALLANT 22 clinical study.