Type 2 diabetes mellitus
Conditions
Interventions
Trade Name: Actos (Pioglitazone)
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Sponsors
The Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Known type 2 diabetic Aged 18-75 years old Caucasian Patients eligible for Pioglitazone In according to NICE guidelines(March 2001) and manufacturer’s guidelines Type 2 diabetes with inadequate glycaemic control HBa1C>7.8% In Combination with metformin only Absence of exclusion criteria 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
Exclusion criteria: Hypertension On insulin therapy Absence of sinus rhythm Left ventricular hypertrophy On ECG and or echocardiography (LIFE study Criteria) Taking drugs known to interfere with the parameters measured Malignancy Poly neuropathy Alcoholism Previous myocardial infarction or CVA 6 months ago Chronic renal failure Chronic liver disease Familial adenomatosis polyposis coli Overt psychiatric illness Contraindications to Pioglitazone (severe Heart Failure, breast feeding, pregnancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To see if Pioglitazone improves the sympathetic nerve hyperactivity observed in type 2 diabetes ;Secondary Objective: ;Primary end point(s): Statistically significant reduction in sympathetic activity in those treated with Pioglitazone | — |
Countries
United Kingdom
Outcome results
None listed