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

B

Biocon

Status and phase

Terminated
Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Insulin Lispro Injection
Drug: IN-105

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

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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