Comparison of efficacy of low dose Pioglitazone with high dose in Patients with Diabetes Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2021/09/036149
- Lead Sponsor
- Multidisciplinary Research Unit of Seth GS medical College and kem hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢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. <br/ ><br>â?¢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. <br/ ><br>Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method â?¢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