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

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

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.

Study Overview

• Status: Terminated
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: IN-105; Drug: Insulin Lispro Injection

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500034
      • Care Hospital
  • Hariyana
    • Karnal, Hariyana, India, 132001
      • Bharti Research Institute of Diabetes and Endocrinology
  • Karnataka
    • Bangalore, Karnataka, India, 560010
      • Diacon Hospital,(Diabetes Care and Research Centre)
    • Bangalore, Karnataka, India, 560052
      • Bangalore Diabetes Hospital
    • Belgaum, Karnataka, India, 590001
      • Belgaum Diabetic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IN105; Prandial Oral Insulin	Drug: IN-105; Prandial Oral Insulin
Active Comparator: Insulin Lispro Injection	Drug: Insulin Lispro Injection; Insulin Lispro Injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biocon Limited
• Investigators: Principal Investigator: Dr. K.M. Prasanna Kumar, MD, DM, CEO and Consultant Endocrinologist, Bangalore Diabetes Hospital, #16/M, Miller tank Bed Area, Thimmaiah Road, Vasanthnagar, Bangalore-560052; Principal Investigator: Dr. Aravind R Sosale, DNB, Director, Diacon Hospital,Diabetes Care and Research Centre, 359-360, 19th Main, Ist Block,Rajajinagar,Bangalore-560010.; Principal Investigator: Dr. Sanjay Kalra, MD, DM, Bharti Research Institute of Diabetes & Endocrinology (BRIDE), Bharti Hospital, Wazir Chand Colony, Kunjpura, karnal, Hariyana- 132001; Principal Investigator: Dr Bipin Kumar Sethi, MD, DM, Care Hospital, Road 1, Banjara Hills, Hyderabad - 500034; Principal Investigator: Dr. Neeta Deshpande, MD, Belgaum Diabetic Centre, Ground floor,Beside mahila Vastu Bhander, Maruti Gali, Belgaum- 590001

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2010
• Primary Completion (Actual): March 12, 2011
• Study Completion (Actual): March 12, 2011

Study Registration Dates

• First Submitted: December 18, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (Estimate): December 21, 2009

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: IN105-CT1-005-09