Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients
NCT ID: NCT01035801
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
20 participants
INTERVENTIONAL
2010-08-21
2011-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IN105
Prandial Oral Insulin
IN-105
Prandial Oral Insulin
Insulin Lispro Injection
Insulin Lispro Injection
Insulin Lispro Injection
Interventions
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IN-105
Prandial Oral Insulin
Insulin Lispro Injection
Insulin Lispro Injection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
No
Sponsors
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Biocon Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. K.M. Prasanna Kumar, MD, DM
Role: PRINCIPAL_INVESTIGATOR
CEO and Consultant Endocrinologist, Bangalore Diabetes Hospital, #16/M, Miller tank Bed Area, Thimmaiah Road, Vasanthnagar, Bangalore-560052
Dr. Aravind R Sosale, DNB
Role: PRINCIPAL_INVESTIGATOR
Director, Diacon Hospital,Diabetes Care and Research Centre, 359-360, 19th Main, Ist Block,Rajajinagar,Bangalore-560010.
Dr. Sanjay Kalra, MD, DM
Role: PRINCIPAL_INVESTIGATOR
Bharti Research Institute of Diabetes & Endocrinology (BRIDE), Bharti Hospital, Wazir Chand Colony, Kunjpura, karnal, Hariyana- 132001
Dr Bipin Kumar Sethi, MD, DM
Role: PRINCIPAL_INVESTIGATOR
Care Hospital, Road 1, Banjara Hills, Hyderabad - 500034
Dr. Neeta Deshpande, MD
Role: PRINCIPAL_INVESTIGATOR
Belgaum Diabetic Centre, Ground floor,Beside mahila Vastu Bhander, Maruti Gali, Belgaum- 590001
Locations
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Care Hospital
Hyderabad, Andhra Pradesh, India
Bharti Research Institute of Diabetes and Endocrinology
Karnāl, Haryana, India
Diacon Hospital,(Diabetes Care and Research Centre)
Bangalore, Karnataka, India
Bangalore Diabetes Hospital
Bangalore, Karnataka, India
Belgaum Diabetic Centre
Belagavi, Karnataka, India
Countries
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Other Identifiers
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IN105-CT1-005-09
Identifier Type: -
Identifier Source: org_study_id
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