Patients with Type 2 diabetes mellitus (T2DM) whoa re not receiving insulin treatment MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent
Conditions
Interventions
Trade Name: Actos (Pioglitazone)
Product Name: Pioglitazone
Pharmaceutical Form: Tablet
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Once selected from the DARTS database, patients must fulfill all of the following criteria: 1. Between 30 and 70 inclusive 2. Type 2 diabetes mellitus 3. Non-insulin dependent 4. BMI 20-35 kg/m2 5. HbA1c =15% within last 12 months 6. BP =160/100 mmHg 7. Ability to understand and willingness to sign the informed consent form 8. Willing to discontinue oral agents for 2 weeks prior to the study 9. Willing to initiate TZD therapy for the duration of the study Patients in cohort 1 must fulfill the following criterion: 1. Genotype Pro12Ala variant of the PPAR-gamma gene Patients in cohort 2 must fulfill the following criterion: 1. Genotype Pro12Pro of the PPAR-gamma gene 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients in both cohorts are to be excluded from the study if they meet any of the following criteria: 1. Patients with existing peripheral oedema 2. Pregnant or lactating women 3. Known to be HIV-positive 4. Known active hepatitis B and/or hepatitis C infection 5. Patients currently receiving diuretics and/or calcium channel blockers 6. History of symptomatic heart failure (NYHA Classes II, III, IV) or LV systolic ejection fraction 2.5 xULN ALT; creatinine >130 µmol/L) 10. Known drug/alcohol abuse 11. Known psychiatric condition 12. Patients requiring insulin therapy or more than 2 oral anti-diabetic drugs 13. Microalbuminuria (as detected by standard clinical screening methods) 14. Patients with severe varicose veins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the influence of the Pro12Ala genotype on body water and oedema formation, detected by ankle-foot volume assessed by water displacement, in patients with T2DM treated with thiazolidinediones (TZD);Secondary Objective: To evaluate the mechanism and biomarkers of this increased risk by careful investigation of the metabolic, cardiovascualr, and renal responses to TZD in theses individuals. To examine the efficacy response of pioglitazone (TZD) between the Pro12Ala and Pro12Pro genotypes;Primary end point(s): The primary aim of the study is: To investigate the influence of the Pro12Ala genotype on body water and oedema formation, detected by ankle-foot volume assessed by water displacement, in patients with T2DM treated with TZD. | — |
Countries
United Kingdom
Outcome results
None listed