Clinical Trial Details
| Trial ID: | L4011 |
| Source ID: | NCT02514850 |
| Associated Drug: | Biochaperone Combo |
| Title: | A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties 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: Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg), Area under the glucose infusion rate curve from 12 hours to 30 hours, from 12h to 30 hours | Secondary: AUCGIR 0-last (mg/kg), Area under the glucose infusion rate curve from 0 hours until the end of clamp, Up to 30 hours|GIRmax (mg/kg/min), Maximum glucose infusion rate, Up to 30 hours|tGIRmax, Time to maximum glucose infusion rate, Up to 30 hours|AUCLis 0-30h, Area under the insulin lispro plasma concentration time curve, Up to 30 hours|AUCGla 0-30h, Area under the insulin glargine plasma concentration time curve, Up to 30 hours|tmax Gla, Time to maximum insulin glargine plasma concentration, Up to 30 hours|tmax Lis, Time to maximum insulin lispro plasma concentration, Up to 30 hours|Adverse events, Number of adverse events, Up to 9 weeks|Hypoglycaemic episodes, Number of Hypoglycaemic episodes, Up to 9 weeks|Local tolerability, Number and intensity of injection site reactions, Up to 9 weeks |
| Sponsor/Collaborators: | Sponsor: Adocia |
| Gender: | ALL |
| Age: | ADULT |
| Phases: | PHASE1 |
| Enrollment: | 24 |
| 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: | 2015-12-02 |
| Locations: | Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany |
| URL: | https://clinicaltrials.gov/show/NCT02514850 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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