CTRI/2021/09/036149尚未招募3 期
A Randomized, Open label, pilot Study to Compare the Efficacy of Pioglitazone (7.5 mg) and Pioglitazone (15 mg) on Glycemic Control in Patients with Type II Diabetes Mellitus who are not controlled on either metformin or both metformin and sulfonylurea.
Multidisciplinary Research Unit of Seth GS medical College and kem hospital0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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