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GALLANT 5 Tesaglitazar Versus Metformin

Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT00214591
Collaborator
(none)
580
Enrollment
130
Locations
28
Duration (Months)
4.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) 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 a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

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 52-wk Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin) 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 :
Dec 1, 2006
Actual Study Completion Date :
Dec 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 (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 co []

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

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

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

  7. Fibrinogen []

  8. Urinary albumin excretion []

  9. Waist/hip ratio []

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

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

  12. Pharmacokinetics of tesaglitazar []

  13. 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 []

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 Birmingham Alabama United States
2 Research Site Columbiana Alabama United States
3 Research Site Mobile Alabama United States
4 Research Site Carlisle Arizona United States
5 Research Center Sherwood Arizona United States
6 Research Site Chula Vista California United States
7 Research Site Escondido California United States
8 Research Site Huntington Beach California United States
9 Research Site Los Angeles California United States
10 Research Site Mission Viejo California United States
11 Research Site Orange California United States
12 Research Site Pasadena California United States
13 Research Site Pomona California United States
14 Research Site Redondo Beach California United States
15 Research Site Sacramento California United States
16 Research Site Colorado Springs Colorado United States
17 Research Site Wheat Ridge Colorado United States
18 Research Site Clearwater Florida United States
19 Research Site Gainesville Florida United States
20 Research Site Hollywood Florida United States
21 Research Site Jacksonville Florida United States
22 Research Site Miami Florida United States
23 Research Site West Palm Beach Florida United States
24 Research Site Atlanta Georgia United States
25 Research Site Brunswick Georgia United States
26 Research Site Carollton Georgia United States
27 Research Site Honolulu Hawaii United States
28 Research Site Boise Idaho United States
29 Research Site Evansville Indiana United States
30 Research Site Kansas City Kansas United States
31 Research Site Overland Park Kansas United States
32 Research Site Witchita Kansas United States
33 Research Site Bossier City Louisiana United States
34 Research Site New Orleans Louisiana United States
35 Research Site Baltimore Maryland United States
36 Research Site Kalamazoo Missouri United States
37 Research Site Las Vegas Nevada United States
38 Research Site Hamilton New Jersey United States
39 Research Site Albuquerque New Mexico United States
40 Research Site Albany New York United States
41 Research Site Bronx New York United States
42 Research Site New York New York United States
43 Research Site Pahrump New York United States
44 Research Site Rochester New York United States
45 Research Site White Plains New York United States
46 Research Site Charlotte North Carolina United States
47 Research Site Cincinnati Ohio United States
48 Research Site Dayton Ohio United States
49 Research Site Kettering Ohio United States
50 Research Site Oklahoma City Oklahoma United States
51 Research Site Medford Oregon United States
52 Research Site Philadelphia Pennsylvania United States
53 Research Site Simpsonville South Carolina United States
54 Research Site Morristown Tennessee United States
55 Research Site Corpus Christi Texas United States
56 Research Site Dallas Texas United States
57 Research Site Lubbock Texas United States
58 Research Site San Antonio Texas United States
59 Research Site Burke Virginia United States
60 Research Site Norfolk Virginia United States
61 Research Site Richmond Virginia United States
62 Research Site Tacoma Washington United States
63 Research Site Menomonee Falls Wisconsin United States
64 Research Site Milwaukee Wisconsin United States
65 Research Site Helsinki Finland
66 Research Site Hämeenlinna Finland
67 Research Site Joensuu Finland
68 Research Site Kouvola Finland
69 Research Site Kuopio Finland
70 Research Site Mikkeli Finland
71 Research Site Oulu Finland
72 Research Site Salo Finland
73 Research Site Tampere Finland
74 Research Site Vantaa Finland
75 Research Site Aschaffenburg Germany
76 Research Site Bad Segeberg Germany
77 Research Site Beckum Germany
78 Research Site Berlin Germany
79 Research Site Dresden Germany
80 Research Site Ehrenberg Germany
81 Research Site Essen Germany
82 Research Site Feldafing Germany
83 Research Site Hamburg Germany
84 Research Site Hannover Germany
85 Research Site Hermaringen Germany
86 Research Site Künzing Germany
87 Research Site Langen Germany
88 Research Site Mannheim Germany
89 Research Site Marl Germany
90 Research Site Nürnberg Germany
91 Research Site Pirna Germany
92 Research Site Rotenburg/Fulda Germany
93 Research Site Ashkelon Israel
94 Research Site Haifa Israel
95 Research Site Holon Israel
96 Research Site Jerusalem Israel
97 Research Site Rishon-Lezion Israel
98 Research Site Tel Aviv Israel
99 Research Site Zefat Israel
100 Research Site Beek en Donk Netherlands
101 Research Site Bennebroe Netherlands
102 Research Site Den Haag Netherlands
103 Research Site Deurne Netherlands
104 Research Site Huizen Netherlands
105 Research Site Losser Netherlands
106 Research Site Nijverdal Netherlands
107 Research Site Rijswijk Netherlands
108 Research Site Roelofarendsveen Netherlands
109 Research Site Rotterdam Netherlands
110 Research Site Bergen Norway
111 Research Site Oslo Norway
112 Research Site Østerås Norway
113 Research Site San Vicente de Raspeig Alicante Spain
114 Research Site Villar del Arzobispo Valencia Spain
115 Research Site Alzira (Valencia) Spain
116 Research Site Barcelona Spain
117 Research Site Begonte (Lugo) Spain
118 Research Site Madrid Spain
119 Research Site Sevilla Spain
120 Research Site Aberdeen United Kingdom
121 Research Site Ayr United Kingdom
122 Research Site Bath United Kingdom
123 Research Site Berks United Kingdom
124 Research Site Bucks United Kingdom
125 Research Site Coventry United Kingdom
126 Research Site Dundee United Kingdom
127 Research Site Glasgow United Kingdom
128 Research Site Manchester United Kingdom
129 Research Sites Northampton United Kingdom
130 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:
NCT00214591
Other Study ID Numbers:
  • D6160C00029
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