A Double-blind, Multi-centre, Active-Controlled (15, 30, and 45mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar (0.5 and 1 mg) in Patients with Type 2 Diabetes Mellitus - GALLEX 6

• Register: EUCTR
• Last refreshed on: 8 May 2012
• Main ID: EUCTR2004-003840-22-FI
• Date of registration: 03/02/2005
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A Double-blind, Multi-centre, Active-Controlled (15, 30, and 45mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar (0.5 and 1 mg) in Patients with Type 2 Diabetes Mellitus - GALLEX 6
• Scientific title: A Double-blind, Multi-centre, Active-Controlled (15, 30, and 45mg Pioglitazone) Long-Term Extension Study to Evaluate the Safety and Tolerability of Oral Tesaglitazar (0.5 and 1 mg) in Patients with Type 2 Diabetes Mellitus - GALLEX 6
• Date of first enrolment: 10/06/2005
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003840-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Finland, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria at enrolment (visit 1):
1. Provision of written informed consent
2. Men and women with type 2 diabetes who have completed the Visits 11 and 12 of the randomised treatment period in the GALLANT 6 study.
3. Female patients must be post menopausal, hysterectomised or if of childbearing potential using a highly effective method of birth control

Post menopausal patients are defined as patients with:
natural or induced menopause with last menstruation >1 year ago or
bilateral oophorectomy
Highly effective birth control is defined as:
double-barrier method (condoms with spermicide, diaphragm with spermicide),
oral contraceptive, implant, long term injectable contraceptive,
intrauterine device (IUD),or
tubal ligation.
However, female patients using oestrogen containing hormonal anti conception method (oral, transdermal, vaginal ring or combination injectables) must agree to use an additional barrier method for contraception (condom or diaphragm).

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:
1.1.1 Exclusion criteria
Any of the following is regarded as a criterion for exclusion from the study:
Exclusion criteria at enrolment (visit 1):
1. Any clinically significant abnormality identified on physical examination, laboratory tests or ECG from GALLANT 6 visit 12, which in the judgment of the investigator would compromise the patients’ safety or successful participation in the study
2. Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes
3. Active arterial disease such as unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular accident, myocardial or peripheral vascular disease revascularization or angioplasty within 24 weeks prior to visit 1
4. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator (Follow local package insert for piogliatzone contraindication, if applicable). For definition, see Appendix F.
5. History of thyroid ophthalmopathy
6. History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma
7. History of blood lipid induced eruptive xanthomas or hypertriglyceridemia induced pancreatitis
8. History of statin-induced myopathy or statin-induced creatine kinase (CK) elevation.
9. Suspicion that the patient is infected according to World Health Organisation (WHO) risk categories 2 to 4. See Appendix G
10. History of alcohol or drug abuse within the last 5 years
11. Patients in any of the handling plans at the end of treatment visit (visit 12) in GALLANT 6
12. Other serious or unstable medical or psychological condition identified in the patient’s medical history that, in the judgment of the investigator, would compromise the patients’ safety or successful participation in the study
13. Previous inclusion in this long term extension study
14. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type II Diabetes Mellitus
MedDRA version: 7 Level: LLT Classification code 10045242

Intervention(s)

Product Name: Tesaglitazar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tesaglitazar
CAS Number: 251565-85-2
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Tesaglitazar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tesaglitazar
CAS Number: 251565-85-2
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: Pioglitazon
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Other descriptive name: Actos
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: Pioglitazon
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Other descriptive name: Actos
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: Pioglitazon
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazone
Other descriptive name: Actos
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Safety of patients

Secondary Objective: To evaluate the effect of tesaglitazar (0.5 and 1 mg) versus pioglitazone (15, 30 and 45 mg), with or without other oral anti-diabetic drugs, when administered up to 104weeks in an extension study from the GALLANT 6 study in patients with type 2 diabetes in modifying glycaemic control by assessment of:
-Changes in glycaemic variables: fasting plasma glucose (FPG) glycosylated haemoglobin A1c (HbA1c), insulin and Homeostasis Assessment Model (HOMA)
-Changes in lipid variables (triglycerides (TG), total cholesterol (TC), LDL-C, high density lipoprotein-cholesterol (HDL-C), non-HDL-C, ApoB/ApoA-1, ApoCIII, FFA, and Lipoprotein particle size)
-Responder rates and proportion of patients on tesaglitazar who reach pre-specified target levels for TG, TC, LDL-C, HDL-C and non-HDL-C
-inflammatory markers by assessment of C-Reactive protein (CRP).

Main Objective: The primary objective is to monitor the long-term safety and tolerability of tesaglitazar (0.5 and 1 mg) versus pioglitazone (15, 30 and 45 mg), with or without other oral anti-diabetic drugs, when administered up to 104weeks in an extension study from the GALLANT 6 study in patients with type 2 diabetes by evaluation of adverse events (AEs), laboratory variables, physical examination, cardiac evaluation, hypoglycaemic events, electrocardiogram (ECG), vital signs (blood pressure (BP) and pulse) and body weight.

Secondary ID(s)

D6160C00048