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GALLANT 6 Tesaglitazar vs. Pioglitazone

Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT00214565
Collaborator
(none)
1,450
Enrollment
74
Locations
26
Duration (Months)
19.6
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Oct 1, 2006
Actual Study Completion Date :
Oct 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) []

Secondary Outcome Measures

  1. The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide []

  2. Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model []

  3. Lipid parameters []

  4. FPG, homeostasis assessment model, insulin, proinsulin, C-peptide []

  5. Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values []

  6. Pharmacokinetics of tesaglitazar []

  7. 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 []

  8. Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36) []

  9. Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only). []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Research Site Altoona Pennsylvania United States
2 Research Site Ciudad de Buenos Aires Argentina
3 Research Site Córdoba Argentina
4 Research Site Moron- Buenos Aires Argentina
5 Research Sites Quilmes - Buenos Aires Argentina
6 Research Site Rosario Argentina
7 Research Site Salta Argentina
8 Research Site Curitiba Brazil
9 Research Site Edmonton Alberta Canada
10 Research Site Abbotsford British Columbia Canada
11 Research Site Chilliwack British Columbia Canada
12 Research Site Vancouver British Columbia Canada
13 Research Site Victoria British Columbia Canada
14 Research Site Dartmouth Nova Scotia Canada
15 Research Site Halifax Nova Scotia Canada
16 Research Site Truro Nova Scotia Canada
17 Research Site Windsor Nova Scotia Canada
18 Research Site Brampton Ontario Canada
19 Research Site Etobicoke Ontario Canada
20 Research Site Kingston Ontario Canada
21 Research Site Niagara Falls Ontario Canada
22 Research Site Oshawa Ontario Canada
23 Research Site Scarborough Ontario Canada
24 Research Site St. Catharines Ontario Canada
25 Research Site Toronto Ontario Canada
26 Research Site Windsor Ontario Canada
27 Research Site Trois-Rivières Quebec Canada
28 Research Site Chicoutimi Canada
29 Research Site Longueuil Canada
30 Research Site Montreal Canada
31 Research Site St. John's Canada
32 Research Site Espoo Finland
33 Research Site Helsinki Finland
34 Research Site Kuopio Finland
35 Research Site Pietarsaar Finland
36 Research Site Pori Finland
37 Research Site Tampere Finland
38 Research Site Guadalajara Jalisco Mexico
39 Research Site Mexico City Mexico
40 Research Site Mexico Mexico
41 Research Site Nuevo Leon Mexico
42 Research Site Puebla Mexico
43 Research Site Torreon Mexico
44 Research Site Zapopan Mexico
45 Research Site Bergen Norway
46 Research Site Elvernum Norway
47 Research Site Hamar Norway
48 Research Site Horten Norway
49 Research Site Kongsberg Norway
50 Research Site Lena Norway
51 Research Site Loeten Norway
52 Research Site Lysaker Norway
53 Research Site Oslo Norway
54 Research Site Osteraas Norway
55 Research Site Skedsmokorset Norway
56 Research Site Straume Norway
57 Research Site Toensberg Norway
58 Research Site Tronheim Norway
59 Research Site Ås Norway
60 Research Site Dublin Ireland United Kingdom
61 Research Site Wexford Ireland United Kingdom
62 Research Site Antrim NI United Kingdom
63 Research Site Belfast United Kingdom
64 Research Site Cardiff United Kingdom
65 Research Site Edinburgh United Kingdom
66 Research Site Glasgow United Kingdom
67 Research Site Kent United Kingdom
68 Research Site Leeds United Kingdom
69 Research Site Mid Glamorgan United Kingdom
70 Research Site Pembrokeshire United Kingdom
71 Research Site Plymouth United Kingdom
72 Research SIte Reading United Kingdom
73 Research Site Surrey United Kingdom
74 Research Site Wiltshire United Kingdom

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Study Director: AstraZeneca Galida Medical Science Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00214565
Other Study ID Numbers:
  • D6160C00030
First Posted:
Sep 22, 2005
Last Update Posted:
Nov 19, 2010
Last Verified:
Nov 1, 2010
Keywords provided by , ,
Type 2 diabetes
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Nov 19, 2010