CTRI/2009/091/001008CompletedPhase 1
An Open Label, Multicenter, Non-randomized, Active Controlled, Single Dose Escalation, Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of IN-105 under Fed Conditions in patients with Type 1 Diabetes Mellitus.
Biocon Research Limited5 sites in 1 country28 target enrollmentStarted: January 8, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Biocon Research Limited
- Enrollment
- 28
- Locations
- 5
- Primary Endpoint
- AUC ratio from 0-130 min for PK and PD with Lispro for different doses
Study Overview
Brief Summary
The study is planned to compare the pharmacokinetics and pharmacodynamics of Lispro with different doses of IN105 in T1DM patients. Data analysis is ongoing.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Day(s) to 45.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Ready for written informed consent.
- •2.Patients of either gender between 18 to 45 years inclusive.
- •3.Established diagnosis of TIDM.
- •4.Body mass Index of 18.5-29.9kg/m2 inclusive.
- •5.Stable weight.
- •6.Glycosylated Haemoglobin (HbAIC) 8.0%at screening.
- •7.On stable insulin or an insulin analogue regimen for atleast 3 months.
Exclusion Criteria
- •â€¢History of hypersensitivity to active or inactive ingredients of the drug •Significant history of atopy or allergic drug reactions.
- •â€¢Abnormal lab parameters – urine, ECG, hepatic and renal function •History of drug or alcohol dependence or abuse within 6 months prior to screening.
- •â€¢Insulin resistance •Patients on glucocorticoids, other blood-glucose lowering drugs •Uncontrolled hypertension and hyperlipidemia •Evidence of severe secondary complications of diabetes •History of hypoglycemia or hypoglycemia unawareness •Any hospitalization or emergency room visit due to poor diabetes control within 6 months prior to screening.
- •â€¢Diseases like coronary artery disease, history of stroke, hematological disorders, planned surgery •Pregnancy, lactation, or planned pregnancy •The patient has received another investigational drug •Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
Outcomes
Primary Outcomes
AUC ratio from 0-130 min for PK and PD with Lispro for different doses
Time Frame: 0-130 min
Secondary Outcomes
- Other PK primary and secondary parameters, PD and PK ratio of AUC at different other time intervals till 250 min(Safety and tolerability)
Investigators
Study Sites (5)
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