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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01035801
• Other study ID #: IN105-CT1-005-09
• Status: Terminated
• Phase: Phase 1
• First received: December 18, 2009
• Last updated: January 19, 2018
• Start date: August 21, 2010
• Est. completion date: March 12, 2011

Study information

• Verified date: January 2018
• Source: Biocon Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 12, 2011
• Est. primary completion date: March 12, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• IN-105
Prandial Oral Insulin
• Insulin Lispro Injection
Insulin Lispro Injection

Locations

Country	Name	City	State
India	Bangalore Diabetes Hospital	Bangalore	Karnataka
India	Diacon Hospital,(Diabetes Care and Research Centre)	Bangalore	Karnataka
India	Belgaum Diabetic Centre	Belgaum	Karnataka
India	Care Hospital	Hyderabad	Andhra Pradesh
India	Bharti Research Institute of Diabetes and Endocrinology	Karnal	Hariyana

Sponsors (1)

Lead Sponsor	Collaborator
Biocon Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (Insulin and Blood Glucose)		0-130 min
Secondary	AUC (Insulin and Blood Glucose)		0-70 min, 0-190 min and 0-250 min
Secondary	Frequency of Adverse Events		9 weeks