A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar Therapy in Patients with Type 2 Diabetes Mellitus (GALLEX 4) - GALLEX 4

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-005243-97-HU
• Date of registration: 25/11/2005
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar Therapy in Patients with Type 2 Diabetes Mellitus (GALLEX 4) - GALLEX 4
• Scientific title: A Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Long Term Extension Study to Evaluate the Safety and Tolerability of oral Tesaglitazar Therapy in Patients with Type 2 Diabetes Mellitus (GALLEX 4) - GALLEX 4
• Date of first enrolment: 15/12/2005
• Target sample size: 400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005243-97
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
For inclusion in the study, patients must fulfil all of the following criteria listed below
1.Provision of a written informed consent at Visit 1
2.Men and women with type 2 diabetes who have completed the Visits 20 and 21 of the randomized treatment period in the GALLANT 4 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, 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:
Any of the following is regarded as a criterion for exclusion from the study:
1.Any clinically significant abnormality identified on physical examination or ECG, which in the judgment of the investigator would compromise the patient’s 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 (TIA), cerebrovascular accident (CVA), myocardial or peripheral vascular disease (PVD) 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
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.Suspicion that the patient is infected according to world health organisation (WHO) risk categories 2 to 4
9.History of drug-induced myopathy or drug-induced CK elevation
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 in GALLANT 4
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 study 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 milligram(s)
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 milligram(s)
Concentration type: equal
Concentration number: 1,0-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Glibenclamide Tablets
Product Name: Glibenclamide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Glibenclamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Glibenclamide Tablets
Product Name: Glibenclamide
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Glibenclamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5,0-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Glibenclamide Tablets
Product Name: Glibenclamide
Pharmaceutical Form: Tablet
INN or Proposed INN: Glibenclamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-

Primary Outcome(s)

Primary end point(s): The GALLEX 4 study is not an end-point study. Please see primary and secondary objectives.

Main Objective: The primary objective of this study is to monitor the long-term safety and tolerability of tesaglitazar (0.5-1 mg) versus glibenclamide (2.5-15 mg), with or without other oral anti-diabetic drugs, when administered for up to 100 weeks in an extension study from the GALLANT 4 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), body weight and height

Secondary Objective: To evaluate the effect of tesaglitazar (0.5-1 mg) versus glibenclamide (2.5-15 mg), with or without other oral anti-diabetic drugs, when administered for up to 100 weeks in an extension study from the GALLANT 4 study in patients with type 2 diabetes
1.in modifying and maintaining durable glycaemic control by assessment of
-time to treatment failure
-changes in glycaemic variables: glycosylated haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG)
-responder rates and proportion of patients who reach pre-specified target levels for HbA1c and FPG
2.on markers of insulin resistance by assessment of insulin and Homeostasis Assessment Model (HOMA).
3.in preserving beta-cell function
4.in modifying lipid control
5.on inflammatory and coagulability markers
6.on urinary albumin excretion.
7.on central obesity

Secondary ID(s)

D6160C00047