Clinical trial NCT01035801: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Biocon Limited
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: AUC (Insulin and Blood Glucose)
timeFrame: 0-130 min
Secondary outcomes:
measure: AUC (Insulin and Blood Glucose)
timeFrame: 0-70 min, 0-190 min and 0-250 min
measure: Frequency of Adverse Events
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Care Hospital
state: Andhra Pradesh
city: Karnal
country: India
facility: Bharti Research Institute of Diabetes and Endocrinology
state: Hariyana
city: Bangalore
country: India
facility: Diacon Hospital,(Diabetes Care and Research Centre)
state: Karnataka
city: Bangalore
country: India
facility: Bangalore Diabetes Hospital
state: Karnataka
city: Belgaum
country: India
facility: Belgaum Diabetic Centre
state: Karnataka
Study officials:
affiliation: CEO and Consultant Endocrinologist, Bangalore Diabetes Hospital, #16/M, Miller tank Bed Area, Thimmaiah Road, Vasanthnagar, Bangalore-560052
name: Dr. K.M. Prasanna Kumar, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Director, Diacon Hospital,Diabetes Care and Research Centre, 359-360, 19th Main, Ist Block,Rajajinagar,Bangalore-560010.
name: Dr. Aravind R Sosale, DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Bharti Research Institute of Diabetes & Endocrinology (BRIDE), Bharti Hospital, Wazir Chand Colony, Kunjpura, karnal, Hariyana- 132001
name: Dr. Sanjay Kalra, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Care Hospital, Road 1, Banjara Hills, Hyderabad - 500034
name: Dr Bipin Kumar Sethi, MD, DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Belgaum Diabetic Centre, Ground floor,Beside mahila Vastu Bhander, Maruti Gali, Belgaum- 590001
name: Dr. Neeta Deshpande, MD
role: PRINCIPAL_INVESTIGATOR
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