NCT01035801终止1 期
An OpenLabel, Multicenter, Non-randomized, ActiveControlled, SingleDose 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
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- AUC (Insulin and Blood Glucose)
研究概览
简要总结
The purpose of this study is to see whether IN-105 (oral insulin) is able to control increase in blood glucose after eating a meal. This study will also tell whether single tablet of IN-105 is safe for patients with Type 1 diabetes mellitus who are currently taking insulin injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients between the ages of 18-45 years inclusive
- •Established diagnosis of T1DM for at least 1-year
- •Body mass index of 18.5-29.9 kg/m2 inclusive
- •Stable weight with no more than 5 kg gain or loss within 3 months of screening
- •HbA1c ≤ 8.0%
- •On stable insulin or an insulin analogue regimen for at least 3 months
排除标准
- •Any hypersensitivity or allergy
- •Positive urine ketones test at screening visit.
- •ECG abnormality
- •total daily insulin >1 IU/kg and/or >0.7 IU/Kg of basal insulin and/or >0.6 IU/Kg of prandial insulin.
- •Patient with a clinically significant abnormality
- •Evidence of severe secondary complications of diabetes
- •History of drug or alcohol dependence or abuse
- •Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control.
- •Patients treated with blood-glucose lowering drugs other than insulin or insulin analogues in the last 4 weeks prior to screening or during the study
- •History of two or more severe episodes of hypoglycemia (defined by ADA criteria) within 6 months prior to screening and/or patients with history of low blood glucose level episodes suggestive of hypoglycemia unawareness (loss of warning symptoms of hypoglycemia). Investigator to assess this criterion based on the subject filled questionnaire.
- •Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
- •Impaired hepatic function (ALT or AST value greater than 2 X Upper limit of reference range and/or serum bilirubin ≥1.5 X Upper limit of reference range at the screening visit).
- •Impaired renal function (serum creatinine ≥1.5 X Upper limit of reference range at screening).
- •Hemoglobinopathies, haemolytic anaemia, anaemia of chronic disease, or any factor affecting the measurement of HbA1c.
- •Any electively planned surgery requiring hospitalization during the study period.
- •Pregnancy, lactation, or planned pregnancy during the study duration.
- •The patient has received another investigational drug within 6 weeks prior to screening
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
研究组 & 干预措施
IN105
Experimental
Prandial Oral Insulin
干预措施: IN-105 (Drug)
Insulin Lispro Injection
Active Comparator
干预措施: Insulin Lispro Injection (Drug)
结局指标
主要结局
AUC (Insulin and Blood Glucose)
时间窗: 0-130 min
次要结局
- AUC (Insulin and Blood Glucose)(0-70 min, 0-190 min and 0-250 min)
- Frequency of Adverse Events(9 weeks)
研究者
研究点 (5)
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