GALLANT 6 Tesaglitazar vs. Pioglitazone
This study has been terminated.
(The development program has been terminated)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00214565
First received: September 20, 2005
Last updated: November 17, 2010
Last verified: November 2010
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Purpose
This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg 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 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Galida |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A 24-Wk Randomised, Double-Blind, Multi-Centre, Active-Controlled (Pioglitazone) Study to Evaluate the Efficacy, Safety & Tolerability of Tesaglitazar Therapy When Administered to Patients With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Secondary Outcome Measures:
- The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
- Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
- Lipid parameters
- FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
- Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
- Pharmacokinetics of tesaglitazar
- Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
- Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
- Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).
| Estimated Enrollment: | 1450 |
| Study Start Date: | August 2004 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provision of a written informed consent
- Men or women who are ³18 years of age
- Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control
- Diagnosed with type 2 diabetes
- Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents
Exclusion Criteria:
- Type 1 diabetes
- New York Heart Association heart failure Class III or IV
- Treatment with chronic insulin
- History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
- History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
- Creatinine levels above twice the normal range
- Creatine kinase above 3 times the upper limit of normal
- Received any investigational product in other clinical studies within 12 weeks
- Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214565
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| United States, Pennsylvania | |
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| Altoona, Pennsylvania, United States | |
| Argentina | |
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| Ciudad de Buenos Aires, Argentina | |
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| Córdoba, Argentina | |
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| Moron- Buenos Aires, Argentina | |
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| Quilmes - Buenos Aires, Argentina | |
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| Rosario, Argentina | |
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| Salta, Argentina | |
| Brazil | |
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| Curitiba, Brazil | |
| Canada, Alberta | |
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| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
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| Abbotsford, British Columbia, Canada | |
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| Chilliwack, British Columbia, Canada | |
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| Vancouver, British Columbia, Canada | |
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| Victoria, British Columbia, Canada | |
| Canada, Nova Scotia | |
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| Dartmouth, Nova Scotia, Canada | |
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| Halifax, Nova Scotia, Canada | |
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| Truro, Nova Scotia, Canada | |
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| Windsor, Nova Scotia, Canada | |
| Canada, Ontario | |
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| Brampton, Ontario, Canada | |
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| Etobicoke, Ontario, Canada | |
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| Kingston, Ontario, Canada | |
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| Niagara Falls, Ontario, Canada | |
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| Oshawa, Ontario, Canada | |
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| Scarborough, Ontario, Canada | |
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| St. Catharines, Ontario, Canada | |
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| Toronto, Ontario, Canada | |
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| Windsor, Ontario, Canada | |
| Canada, Quebec | |
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| Trois-Rivières, Quebec, Canada | |
| Canada | |
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| Chicoutimi, Canada | |
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| Longueuil, Canada | |
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| Montreal, Canada | |
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| St. John's, Canada | |
| Finland | |
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| Espoo, Finland | |
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| Helsinki, Finland | |
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| Kuopio, Finland | |
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| Pietarsaar, Finland | |
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| Pori, Finland | |
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| Tampere, Finland | |
| Mexico | |
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| Guadalajara Jalisco, Mexico | |
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| Mexico, Mexico | |
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| Mexico City, Mexico | |
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| Nuevo Leon, Mexico | |
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| Puebla, Mexico | |
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| Torreon, Mexico | |
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| Zapopan, Mexico | |
| Norway | |
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| Bergen, Norway | |
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| Elvernum, Norway | |
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| Hamar, Norway | |
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| Horten, Norway | |
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| Kongsberg, Norway | |
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| Lena, Norway | |
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| Loeten, Norway | |
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| Lysaker, Norway | |
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| Oslo, Norway | |
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| Osteraas, Norway | |
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| Skedsmokorset, Norway | |
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| Straume, Norway | |
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| Toensberg, Norway | |
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| Tronheim, Norway | |
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| Ås, Norway | |
| United Kingdom | |
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| Dublin, Ireland, United Kingdom | |
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| Wexford, Ireland, United Kingdom | |
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| Antrim, NI, United Kingdom | |
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| Belfast, United Kingdom | |
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| Cardiff, United Kingdom | |
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| Edinburgh, United Kingdom | |
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| Glasgow, United Kingdom | |
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| Kent, United Kingdom | |
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| Leeds, United Kingdom | |
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| Mid Glamorgan, United Kingdom | |
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| Pembrokeshire, United Kingdom | |
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| Plymouth, United Kingdom | |
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| Reading, United Kingdom | |
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| Surrey, United Kingdom | |
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| Wiltshire, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Galida Medical Science Director, MD | AstraZeneca |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00214565 History of Changes |
| Other Study ID Numbers: | D6160C00030 |
| Study First Received: | September 20, 2005 |
| Last Updated: | November 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Type 2 diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013