Diabetes MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Trade Name: Actos tablets
Product Name: Actos
Pharmaceutical Form: Tablet
INN or Proposed INN: pioglitazone
CAS Number: 112529-15-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female type 2 diabetics of any age will be included. There is a wide inclusion criteria to reflect that the 24 participants are a random sample representative of the diabetic clinic attendees. 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: Subjects will be excluded if they have any of the following: Known coronary heart disease Patients receiving Insulin Uncontrolled hypertension (i.e. >160mmHg systolic or >95mmHg diastolic) Systolic dysfunction (ejection fraction <50%) Heart Valve Disease Proliferative or pre-proliferative retinopathy Severe hepatic or renal impairment Possible pregnancy Malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the effects of insulin-sensitizing agent pioglitazone, on heart and artery function.;Secondary Objective: Not applicable.;Primary end point(s): The primary endpoint will be the TDI E' ratio which is the relatively preload independent measure of ventricular diastolic function. | — |
Countries
United Kingdom
Outcome results
None listed