Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients
Phase 1
Terminated
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01035801
- Lead Sponsor
- Biocon Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IN105 IN-105 Prandial Oral Insulin Insulin Lispro Injection Insulin Lispro Injection -
- Primary Outcome Measures
Name Time Method AUC (Insulin and Blood Glucose) 0-130 min
- Secondary Outcome Measures
Name Time Method AUC (Insulin and Blood Glucose) 0-70 min, 0-190 min and 0-250 min Frequency of Adverse Events 9 weeks
Trial Locations
- Locations (5)
Bharti Research Institute of Diabetes and Endocrinology
🇮🇳Karnal, Hariyana, India
Bangalore Diabetes Hospital
🇮🇳Bangalore, Karnataka, India
Care Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Belgaum Diabetic Centre
🇮🇳Belgaum, Karnataka, India
Diacon Hospital,(Diabetes Care and Research Centre)
🇮🇳Bangalore, Karnataka, India