GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00280865

Collaborator

(none)

500

Enrollment

110

Locations

Duration (Months)

4.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 12-week randomized, double-blind, multi-center, active-controlled (open-label pioglitazone) and placebo-controlled study of tesaglitazar (0.1, 0.5, 1, 2, and 3 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 2-week enrollment period, 4 week placebo single blind run in period followed by a 12-week double blind treatment period and a 3-week follow-up period

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Tesaglitazar Drug: Pioglitazone Behavioral: Dietary and Lifestyle Modification Counseling	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes

Study Start Date :

Apr 1, 2002

Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG) []

Secondary Outcome Measures

Changes in the following variables from baseline to the end of the randomized treatment period: []
The change in plasma glucose and insulin during an oral glucose tolerance test []
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model []
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 []
Change in insulin levels and hemoglobin A1c (HbA1c) levels []
Responder analyses for FPG, TG, and HDL C according to pre-specified values []
Pharmacokinetics of tesaglitazar []
To assess the burden of type 2 diabetes mellitus in patients through the administration of the SF-36 health survey and the Well-Being Questionnaire (W BQ12) and comparing the study population data to published national and international normative data []
To evaluate diabetes-specific instruments, Audit of Diabetes Dependent Quality of Life (ADDQoL) and The Diabetes Treatment Satisfaction Questionnaire (DTSQ) (s and c) in the study population and estimate the effect size of the instruments in patients r []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provision of a written informed consent
Men or women who are 30 to 80 years of age
Female patients: postmenopausal or surgically sterile
Diagnosed with type 2 diabetes with C-peptide levels > 0.8 ng/mL
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), or to other PPAR g or PPAR a and g agonists.
History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
Creatinine levels above 1.2 mg/dL
Received any investigational product in other clinical studies within 30 days
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
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Huntsville	Alabama	United States
3	Research Site	Montgomery	Alabama	United States
4	Research Site	Mesa	Arizona	United States
5	Research Site	Phoenix	Arizona	United States
6	Research Site	Tucson	Arizona	United States
7	Research Site	Alhambra	California	United States
8	Research Site	Anaheim	California	United States
9	Research Site	Dinuba	California	United States
10	Research Site	Escondido	California	United States
11	Research Site	Fresno	California	United States
12	Research Site	Greenbrae	California	United States
13	Research Site	Long Beach	California	United States
14	Research Site	Mission Viejo	California	United States
15	Research Site	Orange	California	United States
16	Research Site	Sacramento	California	United States
17	Research Site	San Diego	California	United States
18	Research Site	Walnut Creek	California	United States
19	Research Site	Stamford	Connecticut	United States
20	Research Site	Waterbury	Connecticut	United States
21	Research Site	Washington	District of Columbia	United States
22	Research Site	Brandon	Florida	United States
23	Research Site	Coral Gables	Florida	United States
24	Research Site	DeLand	Florida	United States
25	Research Site	Gainesville	Florida	United States
26	Research Site	Hollywood	Florida	United States
27	Research Site	Miami	Florida	United States
28	Research Site	Atlanta	Georgia	United States
29	Research Site	Augusta	Georgia	United States
30	Research Site	Blue Ridge	Georgia	United States
31	Research Site	Dunwoody	Georgia	United States
32	Research Site	Gurnee	Illinois	United States
33	Research Site	Springfield	Illinois	United States
34	Research Site	Evansville	Indiana	United States
35	Research Site	Indianapolis	Indiana	United States
36	Research Site	Wichita	Kansas	United States
37	Research Site	Louisville	Kentucky	United States
38	Research Site	New Orleans	Louisiana	United States
39	Research Site	Bangor	Maine	United States
40	Research Site	Baltimore	Maryland	United States
41	Research Site	Salisbury	Massachusetts	United States
42	Research Site	Worcester	Massachusetts	United States
43	Research Site	Ann Arbor	Michigan	United States
44	Research Site	Cadillac	Michigan	United States
45	Research Site	Jackson	Mississippi	United States
46	Research Site	St. Louis	Missouri	United States
47	Research Site	Omaha	Nebraska	United States
48	Research Site	Henderson	Nevada	United States
49	Research Site	Las Vegas	Nevada	United States
50	Research Site	Pahrump	Nevada	United States
51	Research Site	Lawrenceville	New Jersey	United States
52	Research Site	Newark	New Jersey	United States
53	Research Site	Albany	New York	United States
54	Research Site	Brooklyn	New York	United States
55	Research Site	Buffalo	New York	United States
56	Research Site	New Hyde Park	New York	United States
57	Research Site	New York	New York	United States
58	Research Site	Charlotte	North Carolina	United States
59	Research Site	Hickory	North Carolina	United States
60	Research Site	Winston-Salem	North Carolina	United States
61	Research Site	Canfield	Ohio	United States
62	Research Site	Cincinnati	Ohio	United States
63	Research Site	Columbus	Ohio	United States
64	Research Site	Kettering	Ohio	United States
65	Research Site	Lakewood	Ohio	United States
66	Research Site	Oklahoma City	Oklahoma	United States
67	Research Site	Eugene	Oregon	United States
68	Research Site	Altoona	Pennsylvania	United States
69	Research Site	Cheswick	Pennsylvania	United States
70	Research Site	Penndel	Pennsylvania	United States
71	Research Site	Philadelphia	Pennsylvania	United States
72	Research Site	Warminster	Pennsylvania	United States
73	Research Site	Warwick	Rhode Island	United States
74	Research Site	Columbia	South Carolina	United States
75	Research Site	Ninety Six	South Carolina	United States
76	Research Site	Summerville	South Carolina	United States
77	Research Site	Sioux Falls	South Dakota	United States
78	Research Site	Arlington	Texas	United States
79	Research Site	Corpus Christi	Texas	United States
80	Research Site	Dallas	Texas	United States
81	Research Site	Lubbock	Texas	United States
82	Research Site	North Richland Hills	Texas	United States
83	Research Site	San Antonio	Texas	United States
84	Research Site	Salt Lake City	Utah	United States
85	Research Site	Falls Church	Virginia	United States
86	Research Site	Norfolk	Virginia	United States
87	Research Site	Richmond	Virginia	United States
88	Research Site	Edmonds	Washington	United States
89	Research Site	Renton	Washington	United States
90	Research Site	Huntington	West Virginia	United States
91	Research Site	Edmonton	Alberta	Canada
92	Research Site	Burlington	Ontario	Canada
93	Research Site	Courtice	Ontario	Canada
94	Research Site	Granby	Quebec	Canada
95	Research Site	Laval	Quebec	Canada
96	Research Site	Longueuil		Canada
97	Research Site	Montreal		Canada
98	Research Site	Sherbrooke		Canada
99	Research Site	Windsor		Canada
100	Research Site	Winnipeg		Canada
101	Research Site	Andard		France
102	Research Site	Angers		France
103	Research Site	Avrille		France
104	Research Site	Chalonnes-sur-Loire		France
105	Research Site	Montrevault		France
106	Research Site	Segre		France
107	Research Site	Tierce		France
108	Research Site	Colonia Seccion XVI		Mexico
109	Research Site	Colonia Valle		Mexico
110	Research Site	Delegacion Cuauhtemoc		Mexico