A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy when Administered as Monotherapy to Drug-Naïve Patients with Type 2 Diabetes - GALLANT 22

• Conditions: Men or women who are 18 years of age or more at enrolment (visit 1). The patients should be drug-naïve with Type 2 diabetes and not on anti-diabetic treatment during the recent 24 weeks.; MedDRA version: 7Level: LLTClassification code 10045242

• Registration Number: EUCTR2004-004374-90-LV
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

Provision of a written informed consent at visit 1.
Men or women who are 18 years of age or more at time of consenting upon visit 1.
Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control...

Diagnosed with type 2 diabetes.

Drug-naïve (ie, no use of antidiabetic drug(s), for at least 24 weeks prior to visit 1). However, one temporary period of daily insulin injections no longer than 7 days during this period is allowed.

For patients <30 years old C-peptide level has to be >0.8 ng/mL, 0.26 nmol/L.
HbA1c 7% up to or equal of 10%. NB Enrolment will be stopped when the cohort of patients having HbA1c more or equal to 7% and less or equal to 7.4% is approximately 25% or the cohort of patients having HbA1c more or equal to 7.5% and less or equal to 10% is approximately 75%.

FPG less than or equal to 13.3 mmol/L, 240 mg/dL.

Inclusion criteria at randomization (visit 5, laboratory values from visit 3 and 4):
HbA1c 7 % up to or equal of 10% (laboratory value from visit 4).

Mean FPG of two measurements (laboratory values from visit 3 and 4) less or equal of 11.7 mmol/L, 210 mg/dL.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes.
Active arterial disease such as unstable angina...
NYHA heart failure Class III or IV, or unstable Class I or II...
History of thyroid ophthalmopathy.
History of malignancy within the last 5 years...
History of blood lipid induced eruptive xanthomas or hypertriglyceridemia induced pancreatitis.
Pregnant or breastfeeding patients.
Suspicion that the patient is infected according to WHO risk categories 2 to 4...
Treatment with fibrates, within 4 weeks prior to visit 1.
Treatment with glucocorticoids (equivalent to oral prednisolon >10 mg per day), within 4 weeks prior to visit 1.
Treatment with probenecid that cannot be stopped at visit 1.
History of hypersensitivity or intolerance to any PPAR-agonist.
History of drug-induced myopathy or drug-induced CK elevation.
History of drug-induced liver enzyme elevations.
History of drug-induced neutropenia.
History of alcohol or drug abuse within the last 5 years.
Other serious or unstable medical or psychological condition...
Receiving any investigational product within 12 weeks prior to visit 1.
Previous enrolment in this study.
Involvement in the planning and conduct of the Clinical Study (applies to both AstraZeneca staff and staff at the investigational site).
Exclusion criteria at placebo run-in (visit 2, laboratory values from visit 1)
Fasting TG >7.0 mmol/L, 620 mg/dL.
Hb <90 g/L, 9 g/dL.
ANC <1.0 x 1 000 000 000/L.
Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert’s syndrome.
Creatinine >2 times the upper limit of normal.
CK >3 times the upper limit of normal.
High BP (mean diastolic BP >120 mm Hg) or malignant hypertension.
Hb <90 g/L, 9 g/dL.
ANC <1.0 x 1 000 000 000/L.
Any of ALT, AST or ALP >2.5 times the upper limit of normal.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified