EUCTR2004-002550-56-DE
Active, not recruiting
Not Applicable
A 24-week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined with Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Glycaemic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients with Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy with a Statin. - GALLANT 14
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Men or women diagnosed with type 2 diabetes and treated with diet alone or on treatment with a single oral anti diabetic agent or low doses of two agents, and with diabetic dyslipidaemia
- Sponsor
- AstraZeneca AB
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria at enrolment (visit 1\):
- •1\.Provision of a written informed consent at visit 1
- •2\.Men or women who are 18 years of age or older at time of consenting upon visit 1
- •3\.Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control.
- •4\.Diagnosed with type 2 diabetes
- •5\.Treated with diet alone or treatment with a single oral anti\-diabetic agent or low doses of two oral anti\-diabetic agents. All anti\-diabetic medications are to be discontinued at visit 1\. Treatment with lipid lowering medication, including statins, must be discontinued at visit 1\.
- •Inclusion criteria at placebo run\-in (visit 2, lab values from visit 1\):
- •6\.For patients \<30 years old C\-peptide concentrations have to be \>0\.8 ng/mL, 0\.26 nmol/L
- •7\.HbA1c equal to or over 7 % for patients not on any anti\-diabetic drug for 12 weeks prior to visit 1\. No lower HbA1c\-limit for patients treated with oral anti\-diabetic drug(s) within 12 weeks prior to visit 1\.
- •8\.HbA1c equal to or lower then 10%
Exclusion Criteria
- •1\.Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid\-induced type 2 diabetes
- •2\.Active arterial disease such as unstable angina, myocardial infarction, transient ischaemic attack, cerebrovascular accident, myocardial or peripheral vascular disease, revascularization or angioplasty within 24 weeks prior to visit 1
- •3\.Patients with heart failure or a history of heart failure (NYHA Class I – IV). For definitions see Appendix F.
- •4\.History of thyroid ophthalmopathy
- •5\.History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma
- •6\.History of blood lipid induced eruptive xanthomas or hypertriglyceridaemia induced pancreatitis
- •7\.Pregnant or breastfeeding patients
- •8\.Suspicion that the patient is infected according to world health organisation (WHO) risk categories 2 to 4 (See Appendix H)
- •9\.Treatment with chronic insulin, within 24 weeks prior to visit 1 (however, one temporary period of daily insulin injections no longer than 7 days is allowed)
- •10\.Treatment with combination therapy (i.e. two anti diabetic agents, except low doses of two agents, see Section 3\.7\) within 12 weeks prior to visit 1
Outcomes
Primary Outcomes
Not specified
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