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

Primary Purpose

Type 1 Diabetes Mellitus

Status

Terminated

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

IN-105

Insulin Lispro Injection

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Care Hospital
Bharti Research Institute of Diabetes and Endocrinology
Diacon Hospital,(Diabetes Care and Research Centre)
Bangalore Diabetes Hospital
Belgaum Diabetic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IN105

Insulin Lispro Injection

Arm Description

Prandial Oral Insulin

Outcomes

Primary Outcome Measures

AUC (Insulin and Blood Glucose)

Secondary Outcome Measures

AUC (Insulin and Blood Glucose)

Frequency of Adverse Events

Full Information

NCT ID

NCT01035801

First Posted

December 18, 2009

Last Updated

January 19, 2018

Sponsor

Biocon Limited

1. Study Identification

Unique Protocol Identification Number

NCT01035801

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Terminated

Why Stopped

This study was temporarily paused due to an unanticipated bioanalytical issue.

Study Start Date

August 21, 2010 (Actual)

Primary Completion Date

March 12, 2011 (Actual)

Study Completion Date

March 12, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biocon Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IN105

Arm Type

Experimental

Arm Description

Prandial Oral Insulin

Arm Title

Insulin Lispro Injection

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

IN-105

Intervention Description

Prandial Oral Insulin

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro Injection

Intervention Description

Insulin Lispro Injection

Primary Outcome Measure Information:

Title

AUC (Insulin and Blood Glucose)

Time Frame

0-130 min

Secondary Outcome Measure Information:

Title

AUC (Insulin and Blood Glucose)

Time Frame

0-70 min, 0-190 min and 0-250 min

Title

Frequency of Adverse Events

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: