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

NCT01035801 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-01-23

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

IN-105

Prandial Oral Insulin

DRUG

Insulin Lispro Injection

Insulin Lispro Injection

Sponsors & Collaborators

  • Biocon Limited

    lead INDUSTRY

Principal Investigators

  • 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

  • Dr. Aravind R Sosale, DNB · Director, Diacon Hospital,Diabetes Care and Research Centre, 359-360, 19th Main, Ist Block,Rajajinagar,Bangalore-560010.

  • Dr. Sanjay Kalra, MD, DM · Bharti Research Institute of Diabetes & Endocrinology (BRIDE), Bharti Hospital, Wazir Chand Colony, Kunjpura, karnal, Hariyana- 132001

  • Dr Bipin Kumar Sethi, MD, DM · Care Hospital, Road 1, Banjara Hills, Hyderabad - 500034

  • Dr. Neeta Deshpande, MD · Belgaum Diabetic Centre, Ground floor,Beside mahila Vastu Bhander, Maruti Gali, Belgaum- 590001

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-21
Primary Completion
2011-03-12
Completion
2011-03-12

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01035801 on ClinicalTrials.gov