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

Biocon

Status and phase: Terminated; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: IN-105; Drug: Insulin Lispro Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01035801

IN105-CT1-005-09

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female patients between the ages of 18-45 years inclusive
2. Established diagnosis of T1DM for at least 1-year
3. Body mass index of 18.5-29.9 kg/m2 inclusive
4. Stable weight with no more than 5 kg gain or loss within 3 months of screening
5. HbA1c ≤ 8.0%
6. On stable insulin or an insulin analogue regimen for at least 3 months

Exclusion criteria

1. Any hypersensitivity or allergy
2. Positive urine ketones test at screening visit.
3. ECG abnormality
4. total daily insulin >1 IU/kg and/or >0.7 IU/Kg of basal insulin and/or >0.6 IU/Kg of prandial insulin.
5. Patient with a clinically significant abnormality
6. Evidence of severe secondary complications of diabetes
7. History of drug or alcohol dependence or abuse
8. Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control.
9. 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
10. 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.
11. Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
12. 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).
13. Impaired renal function (serum creatinine ≥1.5 X Upper limit of reference range at screening).
14. Hemoglobinopathies, haemolytic anaemia, anaemia of chronic disease, or any factor affecting the measurement of HbA1c.
15. Any electively planned surgery requiring hospitalization during the study period.
16. Pregnancy, lactation, or planned pregnancy during the study duration.
17. The patient has received another investigational drug within 6 weeks prior to screening
18. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

IN105

Experimental group

Description:

Prandial Oral Insulin

Treatment:

Drug: IN-105

Insulin Lispro Injection

Active Comparator group

Treatment:

Drug: Insulin Lispro Injection