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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Biocon Limited.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Biocon Limited
ClinicalTrials.gov Identifier:
NCT01035801
First received: December 18, 2009
Last updated: August 19, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: IN-105
Drug: Insulin Lispro Injection
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biocon Limited:

Primary Outcome Measures:
  • AUC (Insulin and Blood Glucose) [ Time Frame: 0-130 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC (Insulin and Blood Glucose) [ Time Frame: 0-70 min, 0-190 min and 0-250 min ] [ Designated as safety issue: No ]
  • Frequency of Adverse Events [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: August 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IN105
Prandial Oral Insulin
Drug: IN-105
Prandial Oral Insulin
Active Comparator: Insulin Lispro Injection Drug: Insulin Lispro Injection
Insulin Lispro Injection

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035801

Contacts
Contact: Dr Manish Verma, MD 91 80 28082808 ext 2342 manish.verma@biocon.com
Contact: Dr Sharmitha Krishnamurthy, BDS 91 80 28082808 ext 2304 sharmitha.krishnamurthy@biocon.com

Locations
India
Care Hospital Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Dr Bipin Kumar Sethi, MD, DM    +91 4066258792    bipinkumarsethi@yahoo.co.uk   
Principal Investigator: Dr Bipin Kumar Sethi, MD, DM         
Bharti Research Institute of Diabetes and Endocrinology Recruiting
Karnal, Hariyana, India, 132001
Contact: Dr Sanjay Kalra, MD, DM    + 91(184)2268484    brideknl@gmail.com   
Principal Investigator: Dr Sanjay Kalra, MD, DNB         
Bangalore Diabetes Hospital Recruiting
Bangalore, Karnataka, India, 560052
Contact: Dr. K.M. Prasanna Kumar, MD, DM    +91 80 22372980    dr.kmpk@gmail.com   
Principal Investigator: Dr.K.M Prasanna Kumar, MD, DM         
Diacon Hospital,(Diabetes Care and Research Centre) Recruiting
Bangalore, Karnataka, India, 560010
Contact: Dr. Aravind R Sosale, DNB    +91 80 23130553    aravindsosale@gmail.com   
Principal Investigator: Dr.Aravind R Sosale, DNB         
Belgaum Diabetic Centre Not yet recruiting
Belgaum, Karnataka, India, 590001
Contact: Dr Neeta Deshpande, MD    +91 831 2446335    neetarohit@gmail.com   
Principal Investigator: Dr Neeta Deshpande, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr Manish Verma, Manager, Biocon Limited
ClinicalTrials.gov Identifier: NCT01035801     History of Changes
Other Study ID Numbers: IN105-CT1-005-09
Study First Received: December 18, 2009
Last Updated: August 19, 2010
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin Lispro
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014