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GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin

Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT00242372
Collaborator
(none)
370
Enrollment
71
Locations
19
Duration (Months)
5.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tesaglitazar 0.5
  • Drug: Insulin at least 30 units/day
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A 24-Week Randomised, Double-Blind, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy When Added to the Therapy of Patients With Type 2 Diabetes Poorly Controlled on Insulin
Study Start Date :
Aug 1, 2004
Actual Study Completion Date :
Mar 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. Changes in the following variables from baseline to the end of the randomized treatment period: []

  2. The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide from baseline to the end of the randomized treatment period []

  3. Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model from baseline to the end of the randomized treatment period []

  4. Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and c []

  5. C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio []

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

  7. Tumor necrosis factor-alpha, intracellular adhesion molecule-1 []

  8. Fibrinogen []

  9. Urinary albumin excretion []

  10. Waist/hip ratio []

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

  12. Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C []

  13. Pharmacokinetics of tesaglitazar []

  14. 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 []

  15. To validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI-Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) in patients with type 2 diabetes and to explore the effects of tesaglitazar (0.5 mg) on pati []

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 >=18 years of age

  • Female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control

  • Diagnosed with type 2 diabetes for less than 20 years and receiving at least 30 U insulin per day

Exclusion Criteria:

  • Type 1 diabetes

  • New York Heart Association heart failure Class III or IV

  • Treatment with any thiazolidinedione class of antidiabetic agents

  • 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 Birmingham Alabama United States
2 Research Site Phoenix Arizona United States
3 Research Site Tuscson Arizona United States
4 Research Site Fresno California United States
5 Research Site Greenbrae California United States
6 Research Site La Jolla California United States
7 Research Site Northridge California United States
8 Research Site Riverside California United States
9 Research Site San Diego California United States
10 Research Site Santa Monica California United States
11 Research Site Spring Valley California United States
12 Research Site Walnut Creek California United States
13 Research Site West Hills California United States
14 Research Site Waterbury Connecticut United States
15 Research Site Washington District of Columbia United States
16 Research Site Gainesville Florida United States
17 Research Site Hollywood Florida United States
18 Research Site Jacksonville Florida United States
19 Research Site Miami Florida United States
20 Research Site Orlando Florida United States
21 Research Site Palm Harbor Florida United States
22 Research Site West Palm Beach Florida United States
23 Research Site Augusta Georgia United States
24 Research Site Dunwoody Georgia United States
25 Research Site Boise Idaho United States
26 Research Site Chicago Heights Illinois United States
27 Research Site Chicago Illinois United States
28 Research Site Gurnee Illinois United States
29 Research Site Maywood Illinois United States
30 Research Site Springfield Illinois United States
31 Research Site Indianapolis Indiana United States
32 Research Site Wichita Kansas United States
33 Research Site New Orleans Louisiana United States
34 Research Site Baltimore Maryland United States
35 Research Site Bethesda Maryland United States
36 Research Site Cadillac Michigan United States
37 Research Site Richmond Heights Missouri United States
38 Research Site St Louis Missouri United States
39 Research Site Omaha Nebraska United States
40 Research Site North Las Vegas Nevada United States
41 Research Site Pahrump Nevada United States
42 Research Site Dover New Hampshire United States
43 Research Site Roseland New Jersey United States
44 Research Site Albuquerque New Mexico United States
45 Research Site Brooklyn New York United States
46 Research Site New Hyde Park New York United States
47 Research Site Charlotte North Carolina United States
48 Research Site Wilmington North Carolina United States
49 Research Site Cincinnati Ohio United States
50 Research Site Kettering Ohio United States
51 Research Site Toledo Ohio United States
52 Research Site Oklahoma City Oklahoma United States
53 Research Site Medford Oregon United States
54 Research Site Portland Oregon United States
55 Research Site Altoona Pennsylvania United States
56 Research Site Cheswick Pennsylvania United States
57 Research Site Erie Pennsylvania United States
58 Research Site Philadelphia Pennsylvania United States
59 Research Site Columbia South Carolina United States
60 Research Site Greer South Carolina United States
61 Research Site Corpus Christie Texas United States
62 Research Site Dallas Texas United States
63 Research Site Fort Worth Texas United States
64 Research Site Houston Texas United States
65 Research Site San Antonio Texas United States
66 Research Site Richmond Virginia United States
67 Research Site Bellevue Washington United States
68 Research Site Renton Washington United States
69 Research Site Spokane Washington United States
70 Research Site Tacoma Washington United States
71 Research Site Madison Wisconsin United States

Sponsors and Collaborators

  • AstraZeneca

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00242372
Other Study ID Numbers:
  • D6160C00033
First Posted:
Oct 20, 2005
Last Update Posted:
Apr 22, 2009
Last Verified:
Apr 1, 2009
Keywords provided by , ,
Insulin dependent Type 2 diabetes
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin

Study Results

No Results Posted as of Apr 22, 2009