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Clinical Trial Details

Trial ID: L6340
Source ID: NCT02514954
Associated Drug: Biochaperone® Combo
Title: Postprandial Blood Glucose Control With BioChaperone® Combo and Insulin Lispro (Humalog®) Mix 25 in People With Type 1 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Biochaperone® Combo|DRUG: Humalog® Mix25
Outcome Measures: Primary: Delta AUCBG,0-2h, Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal, 2 hours | Secondary: Delta AUCBG,0-6h, Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal, 6 hours|BGmax, Maximum blood glucose concentration after a standardised meal (0-6 hours), 6 hours|tBGmax, Time to maximum blood glucose concentration after a standardised meal (0-6 hours), 6 hours|AUCLisp,0-6h,, Area under the plasma insulin lispro concentration-time curve from 0-6 hours, 6 hours|AUCGlarg,0-6h, Area under the plasma insulin glargine concentration-time curve from 0-6 hours, 6 hours|Cmax,Lisp, Maximum observed plasma insulin lispro concentration, 6 hours|Cmax,Glarg, Maximum observed plasma insulin glargine concentration, 6 hours|Adverse events, Number of adverse events, Up to 7 weeks|Local tolerability, Number and intensity of injection site reactions, Up to 7 weeks
Sponsor/Collaborators: Sponsor: Adocia
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-07
Completion Date: 2015-11
Results First Posted:
Last Update Posted: 2015-11-06
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT02514954