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Regular insulin

Phase 2

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Becton, Dickinson and Company|Last Updated: Aug 22, 2008

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical trial landscape

Regular insulin · 1 trial · 1 indication

Phase 2 1
NCT00553488Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After EatingDiabetes Mellitus, Type 1
COMPLETED30 Analytics
PHASE2COMPLETED
Feasibility Study of the Effect of Intra-Dermal Insulin Injection on Blood Glucose Levels After Eating
Diabetes Mellitus, Type 1Unlock trial analytics
Study Endpoints
Primary Endpoints
Area Under Curve (AUC) of the blood glucose (BG) profile after the meal, with and without baseline correction.
90 mins
Secondary Endpoints
Maximal BG (BGmax)
Approximately 4 hours per injection
Total BG-AUC0-4 h
Approximately 4 hrs per injection
Minimal BG (BGmin, time to BGmin (tBGmin)
Approximately 4 hrs per injection
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORRegular insulin SC at -17 mins
2ACTIVE_COMPARATORRegular insulin ID at -17 mins
3ACTIVE_COMPARATORRegular insulin ID at -2 mins
4ACTIVE_COMPARATORInsulin lispro given SC at -2 mins
5EXPERIMENTALInsulin lispro given ID at -2 mins
Interventions
NameTypeDescription
Regular insulin (Humulin)DRUGInsulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
Insulin lispro (Humalog)DRUGInsulin will be given either subcutaneously or intra-dermally, and at two different times prior to the liquid meal (T zero). At -17 mins, regular insulin will be given either SC or ID. At -2 mins, regular insulin will be given ID; also insulin lispro will be given either SC or ID. Each patient will receive 1 injection on 5 different study days.
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Eligibility Criteria
Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 1 diabetes for 1-15 years, on multiple daily injections (MDI) or insulin pump (CSII) in stable control with HbA1c \<= 9.0%. * Able to attend clinic for 5 different days Exclusion Criteria: * BMI \> 32 kg/m2 * Evidence of gastroparesis or impaired renal function or lipod...

Countries:Germany
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