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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035801
Recruitment Status : Terminated (This study was temporarily paused due to an unanticipated bioanalytical issue.)
First Posted : December 21, 2009
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Biocon Limited

December 18, 2009
December 21, 2009
January 23, 2018
August 21, 2010
March 12, 2011   (Final data collection date for primary outcome measure)
AUC (Insulin and Blood Glucose) [ Time Frame: 0-130 min ]
Same as current
Complete list of historical versions of study NCT01035801 on Archive Site
  • AUC (Insulin and Blood Glucose) [ Time Frame: 0-70 min, 0-190 min and 0-250 min ]
  • Frequency of Adverse Events [ Time Frame: 9 weeks ]
Same as current
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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
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
March 12, 2011
March 12, 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.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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
January 2018

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