CTRI/2009/091/001008已完成1 期
An Open Label, Multicenter, Non-randomized, Active Controlled, Single Dose Escalation, Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of IN-105 under Fed Conditions in patients with Type 1 Diabetes Mellitus.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- AUC ratio from 0-130 min for PK and PD with Lispro for different doses
研究概览
简要总结
The study is planned to compare the pharmacokinetics and pharmacodynamics of Lispro with different doses of IN105 in T1DM patients. Data analysis is ongoing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Day(s) 至 45.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Ready for written informed consent.
- •2.Patients of either gender between 18 to 45 years inclusive.
- •3.Established diagnosis of TIDM.
- •4.Body mass Index of 18.5-29.9kg/m2 inclusive.
- •5.Stable weight.
- •6.Glycosylated Haemoglobin (HbAIC) 8.0%at screening.
- •7.On stable insulin or an insulin analogue regimen for atleast 3 months.
排除标准
- •â€¢History of hypersensitivity to active or inactive ingredients of the drug •Significant history of atopy or allergic drug reactions.
- •â€¢Abnormal lab parameters – urine, ECG, hepatic and renal function •History of drug or alcohol dependence or abuse within 6 months prior to screening.
- •â€¢Insulin resistance •Patients on glucocorticoids, other blood-glucose lowering drugs •Uncontrolled hypertension and hyperlipidemia •Evidence of severe secondary complications of diabetes •History of hypoglycemia or hypoglycemia unawareness •Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
- •â€¢Diseases like coronary artery disease, history of stroke, hematological disorders, planned surgery •Pregnancy, lactation, or planned pregnancy •The patient has received another investigational drug •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
结局指标
主要结局
AUC ratio from 0-130 min for PK and PD with Lispro for different doses
时间窗: 0-130 min
次要结局
- Other PK primary and secondary parameters, PD and PK ratio of AUC at different other time intervals till 250 min(Safety and tolerability)
研究者
研究点 (5)
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