A Comparative Study of Lobeglitazone Versus Pioglitazone on Urinary Albumin to Creatinine Ratio (UACR) In Normotensive and Hypertensive Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Comparative assessment of the change in UACR from baseline between lobeglitazone and pioglitazone in both normotensive and hypertensive T2DM patients.
研究概览
简要总结
High blood glucose levels are responsible for causing kidney damage. Studies have demonstrated that TZDs can lead to improvements in albuminuria levels in individuals with T2DM. Unlike some other medications, TZDs have shown to have a neutral impact on the progression of DKD and do not necessitate dosage adjustments based on kidney function. Pioglitazone has achieved remarkable improvements of diabetic albuminuria regardless of baseline kidney function; it was also advantageous in terms of preserving kidney function in uncontrolled T2D patients, as add-on therapy, compared to basal insulin. Lobeglitazone is a novel TZD developed in Korea that has been used in several countries to treat patients with T2DM. However, to date, the efficacy of lobeglitazone for reducing albuminuria in T2DM patients in Indian population has not been studied. Also the efficacy of TZDs for reducing albuminuria in hypertensive patients has not been studied.
RESEARCH QUESTION
Is there a significant difference in effectiveness of Lobeglitazone and Pioglitazone in reducing urinary albumin to creatinine ratio (UACR) in normotensive and hypertensive type 2 diabetic patients?
Aim:
To compare the effect of lobeglitazone versus pioglitazone on urine albumin to creatinine ratio (UACR) in normotensive and hypertensive T2DM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •T2DM patients of either gender between age group 18 to 60 years.
- •HBA1c between 6.5 to 8.
- •T2DM patients taking other oral antidiabetic drugs excluding the study drugs Lobeglitazone and Pioglitazone.
- •T2DM normotensive patients.
- •T2DM hypertensive patients taking either ACE inhibitors or ARBs with BP controlled to less than 140/90 mmHg. 6) T2DM patients with UACR between 30 to 300 mg per grams.
排除标准
- •Type 1 Diabetes mellitus.
- •Other secondary forms of diabetes 3) Patients with HBA1c more than 8.5 (uncontrolled diabetes).
- •T2DM patients with uncontrolled hypertension (greater than 140/90mmHg).
- •T2DM patients using insulin.
- •T2DM patients using TZDs within 60 days prior to consent.
- •Known hypersensitivity to TZDs. 8) T2DM patients with overt albuminuria 9) H/O macular edema 10) Congestive cardiac failure 11) Ischemic stroke or cerebral haemorrhage.
- •Hepatic dysfunction 13) H/O fractures 14) Active infection and trauma 15) Unable or unwilling to provide written informed consent.
结局指标
主要结局
Comparative assessment of the change in UACR from baseline between lobeglitazone and pioglitazone in both normotensive and hypertensive T2DM patients.
时间窗: 6 months
次要结局
- To study the effect of Lobeglitazone and Pioglitazone on UACR in normotensive T2DM patients.(6 months)
- To evaluate effect of Lobeglitazone and Pioglitazone on UACR in hypertensive T2DM patients.(6 months)
- To compare the effect of Lobeglitazone v/s Pioglitazone on UACR in normotensive and hypertensive T2DM patients(6 months)
- To study and compare the effect of Lobeglitazone v/s Pioglitazone on Glycaemic parameters in both groups of T2DM patients(6 months)
- To study and compare the safety of lobeglitazone v/s pioglitazone per se patient reported adverse drug reactions(6 months)
研究者
Dr Minakshi S ghuge
MGM medical college and hospital