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. - TIDM
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
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
- •History of hypersensitivity to active or inactive ingredients of the drug
- •Significant history of atopy or allergic drug reactions.
- •Abnormal lab parameters â?? urine, ECG, hepatic and renal function
- •History of drug or alcohol dependence or abuse within 6 months prior to screening.
- •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.
- •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.
研究者
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