Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Glycaemic control
研究概览
简要总结
It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen & Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic Human Insulin can be used in a thrice daily regimen in place of BIAsp.
As the regimen is less expensive and one prick less than the basal-bolus regimen, it can be a good alternative for a diabetics in India.
This is a 12 week Open labelled parallel-Randomised controlled pilot study - 50 patients with type 2 Diabetes mellitus was selected after satisfying the inclusion and exclusion criteria's .Metformin and pioglitazone were continued and they are randomised into 2 groups at base line and was allotted into any of the two regimens.
- Basal detemir + bolus aspart or
- Thrice Daily Biphasic Human Insulin Regimen.
The two regimens were compared by the following variables:
Primary endpoint:
Glycaemic control
Secondary endpoint:
Weight gain, Hypoglycaemic episodes, Adverse effects and Cost effectiveness
详细描述
It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen & Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic Human Insulin can be used in a thrice daily regimen in place of BIAsp.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetics >/= 18 yrs of age Diabetic for >/= 6months
- •Inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pio30mg/d
- •Single dose of insulin exceeding 25 units or total insulin dose is more than 0.7u/kg/day with
- •If post lunch blood glucose is not controlled
- •If HbA1c ≥7%
- •No major cardiac events in the preceding 6 months.
- •NYHA <= Class II.
排除标准
- •Deranged LFT's- AST,ALT or ALP values >= 2 times.
- •Deranged RFT Sr. Creatinine >=1.5
- •Allergy to Insulin or its products.
- •Recent intake of any new medications for sugar control.
- •Illiterate to the level that she/he cannot understand the study.
- •Any other acute co morbid illness.
- •Pregnancy.
- •Decompensated heart failure/UsA/MI all within last 12month
- •Untreated proliferative retinopathy/ maculopathy
- •Drug or alcohol dependence
结局指标
主要结局
Glycaemic control
时间窗: 3months
次要结局
- Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness(3 months)
研究者
Anil Bhansali
prof and head
Post Graduate Institute of Medical Education and Research, Chandigarh