Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Insulin (IN-105) in Type 1 Diabetes Patients
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes Mellitus | Drug: IN-105 Drug: Insulin Lispro Injection | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Actual Study Start Date : | August 21, 2010 |
Actual Primary Completion Date : | March 12, 2011 |
Actual Study Completion Date : | March 12, 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: IN105
Prandial Oral Insulin
|
Drug: IN-105
Prandial Oral Insulin |
Active Comparator: Insulin Lispro Injection |
Drug: Insulin Lispro Injection
Insulin Lispro Injection |
- AUC (Insulin and Blood Glucose) [ Time Frame: 0-130 min ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female patients between the ages of 18-45 years inclusive
- Established diagnosis of T1DM for at least 1-year
- Body mass index of 18.5-29.9 kg/m2 inclusive
- Stable weight with no more than 5 kg gain or loss within 3 months of screening
- HbA1c ≤ 8.0%
- On stable insulin or an insulin analogue regimen for at least 3 months
Exclusion Criteria:
- Any hypersensitivity or allergy
- Positive urine ketones test at screening visit.
- ECG abnormality
- total daily insulin >1 IU/kg and/or >0.7 IU/Kg of basal insulin and/or >0.6 IU/Kg of prandial insulin.
- Patient with a clinically significant abnormality
- Evidence of severe secondary complications of diabetes
- History of drug or alcohol dependence or abuse
- Patients currently on systemic or inhaled glucocorticoids or other drugs, which may affect glycemic control.
- 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
- 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.
- Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
- 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).
- Impaired renal function (serum creatinine ≥1.5 X Upper limit of reference range at screening).
- Hemoglobinopathies, haemolytic anaemia, anaemia of chronic disease, or any factor affecting the measurement of HbA1c.
- Any electively planned surgery requiring hospitalization during the study period.
- Pregnancy, lactation, or planned pregnancy during the study duration.
- The patient has received another investigational drug within 6 weeks prior to screening
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035801
India | |
Care Hospital | |
Hyderabad, Andhra Pradesh, India, 500034 | |
Bharti Research Institute of Diabetes and Endocrinology | |
Karnal, Hariyana, India, 132001 | |
Diacon Hospital,(Diabetes Care and Research Centre) | |
Bangalore, Karnataka, India, 560010 | |
Bangalore Diabetes Hospital | |
Bangalore, Karnataka, India, 560052 | |
Belgaum Diabetic Centre | |
Belgaum, Karnataka, India, 590001 |
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 |
Responsible Party: | Biocon Limited |
ClinicalTrials.gov Identifier: | NCT01035801 |
Other Study ID Numbers: |
IN105-CT1-005-09 |
First Posted: | December 21, 2009 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs |