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

December 18, 2009
August 19, 2010
August 2010
February 2011   (final data collection date for primary outcome measure)
AUC (Insulin and Blood Glucose) [ Time Frame: 0-130 min ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035801 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Drug: IN-105
    Prandial Oral Insulin
  • Drug: Insulin Lispro Injection
    Insulin Lispro Injection
  • Experimental: IN105
    Prandial Oral Insulin
    Intervention: Drug: IN-105
  • Active Comparator: Insulin Lispro Injection
    Intervention: Drug: Insulin Lispro Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
No
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
India
 
NCT01035801
IN105-CT1-005-09
No
Dr Manish Verma, Manager, Biocon Limited
Biocon Limited
Not Provided
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
Biocon Limited
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP