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Clinical Trial Details

Trial ID: L4864
Source ID: NCT02915250
Associated Drug: Biochaperone® Combo
Title: A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: BioChaperone® Combo|DRUG: Humalog® Mix25|DRUG: Humalog®|DRUG: Lantus®|DRUG: Placebo
Outcome Measures: Primary: Delta AUC BG 0-2h (area under the blood glucose concentration-time curve), Mean of incremental areas under the blood glucose concentration-time curve from 0-2 hours after a standardised meal on Day 2 and Day 3, From 0 to 2 hours | Secondary: Partial delta AUCs BG and total AUCs BG, Partial incremental AUCs BG and total AUCs BG in the 0-6 time range, From 0 to 6 hours|Mean and mean change from baseline of blood glucose at different time points, From 0 to 6 hours|Delta BGmax and delta BGmin, Maximum and minimum blood glucose excursions after a standardised meal, From 0 to 6 hours|BGmax and BGmin, Maximum and minimum blood glucose concentrations after a standardised meal, From 0 to 6 hours|AUC Insulin, Partial areas under the insulins plasma concentration time curve, From 0 to 24 hours|Cmax Insulin, Maximum observed plasma insulins concentration, From 0 to 6 hours|tmax Insulin, Time to maximum observed plasma insulins concentration, From 0 to 6 hours|Adverse Events, Up to 12 weeks (maximum duration of subject's participation)|Local tolerability, Up to 12 weeks (maximum duration of subject's participation)|Hypoglycaemic events, Up to 12 weeks (maximum duration of subject's participation)
Sponsor/Collaborators: Sponsor: Adocia
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 36
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-10
Completion Date: 2017-06
Results First Posted:
Last Update Posted: 2017-06-29
Locations: Profil Mainz GmbH & Co.KG, Mainz, 55116, Germany|Profil GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT02915250