Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: IN-105
* Drug: Insulin Lispro Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IN105<br>Prandial Oral Insulin | Drug: IN-105<br>* Prandial Oral Insulin<br>|
| Active Comparator: Insulin Lispro Injection<br> | Drug: Insulin Lispro Injection<br>* Insulin Lispro Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (Insulin and Blood Glucose) |  | 0-130 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (Insulin and Blood Glucose) |  | 0-70 min, 0-190 min and 0-250 min | 
| Frequency of Adverse Events |  | 9 weeks |