| Trial ID: | L3990 |
| Source ID: | NCT03180710
|
| Associated Drug: |
Biochaperone® Combo 75/25 At 0.6 U/Kg
|
| Title: |
A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: BioChaperone® Combo 75/25 at 0.6 U/kg|DRUG: BioChaperone® Combo 75/25 at 0.8 U/kg|DRUG: BioChaperone® Combo 75/25 at 1.0 U/kg|DRUG: Humalog® Mix25 at 0.8 U/kg
|
| Outcome Measures: |
Primary: AUC last_total, Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations., From 0 to 30 hours|Cmax_total, Maximum observed plasma insulin total concentration, From 0 to 30 hours | Secondary: AUCGIR 0-last (mg/kg), Area under the glucose infusion rate curve from 0 hours until the end of clamp, From 0 to 30 hours|GIRmax (mg/kg/min), Maximum glucose infusion rate, From 0 to 30 hours|tGIRmax, Time to maximum glucose infusion rate, From 0 to 30 hours|Adverse Events, Up to 102 days (maximum duration of subject's participation)|Local tolerability: number of injection site reaction, Frequency of injection site reaction in each arm., Up to 102 days (maximum duration of subject's participation)|Number of hypoglycaemic events in each treatment arm, Up to 102 days (maximum duration of subject's participation)
|
| Sponsor/Collaborators: |
Sponsor: Adocia
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-06-06
|
| Completion Date: |
2017-12-21
|
| Results First Posted: |
|
| Last Update Posted: |
2018-01-10
|
| Locations: |
Profil Mainz GmbH & Co. KG, Mainz, Germany|Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03180710
|
