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 :
(This study was temporarily paused due to an unanticipated bioanalytical issue.)
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.
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
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Any hypersensitivity or allergy
Positive urine ketones test at screening visit.
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.