Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Pioglitazone: 7.5 mg orally OD for 12 months
Control Intervention1: Pioglitazone: 15 mg orally OD for 12 months
Sponsors
Multidisciplinary Research Unit of Seth GS medical College and kem hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female, aged 18 to 50 years and have been diagnosed as T2DM. 2. Patient satisfying the definition of metformin failure i.e. those not achieving target HbA1c despite continuous 3 months of treatment with maximum allowed dose of Metformin (2550 mg per day) and half maximum allowed dose of sulfonylureas. 3. BMI 20.0 to 45.0 kg/m2. 4. Agrees for long term follow up and has consented to study procedures.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to pioglitazone or any of its components. 2. Evidence of pregnancy (Any one of: Positive UPT, USG evidence or bearing a prescription with clinical diagnosis of pregnancy) 3. Participation in another trial or receipt of any investigational medicinal product within 90 days prior to screening visit. 4. History of episode of level 3 hypoglycaemia or elicitable history of recurrent any level of hypoglycaemia as judged by the Investigator. 5. Treatment with hypoglycaemic agent other than that stated in the inclusion criteria in a period of 12 weeks prior to screening. 6. T1DM or Secondary diabetes. 7. History of acute metabolic complications of diabetes within 3 months prior to screening visit. 8. Any of the following in past 3 months: Episode of unstable angina, ACS, or other significant cardiovascular event (including Arrhythmias or conduction delays on ECG or cerebral stroke). 9. Diagnosis of NYHA Class IV. 10. Uncontrolled treated or untreated hypertension. 11. Renal impairment 12. Hepatic impairment 13. Ischaemic heart disease as evidenced on ECG 14. Known intake of opioids or abuse of alcohol or suspected abuse of alcohol. 15. History of chronic pancreatitis or idiopathic acute pancreatitis. 16. Any history of or diagnosis / treatment of any form of cancer within last 5 years. 17. Any history of severe neuropathy which prevents patient from complying with study procedures 18. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator. 19. Patient on medication that may promote hyperglycaemia or hypoglycaemia. 20. Mental incapacity, unwillingness or language barrier precluding adequate understanding and/or cooperation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •To compare the efficacy of two doses of Pioglitazone (7.5 mg and 15 mg) in reducing HbA1C in patients with Type II Diabetes Mellitus who are not controlled on metformin and sulphonylurea or metformin alone. •To compare the efficacy of two doses of Pioglitazone (7.5 mg and 15 mg) in reducing fasting plasma glucose in patients with Type II Diabetes Mellitus who are not controlled on metformin and sulphonylurea or metformin alone. Timepoint: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare the effect of adding Pioglitazone 7.5 mg versus Pioglitazone 15 mg to pre-existing maximum allowed dose of metformin and half maximal dose of sulphonylurea therapy on lipid profile parameters.Timepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Tushar Bandgar
Seth GS Medical College and KEM Hospital, Parel, Mumbai
Outcome results
None listed