| Trial ID: | L5952 |
| Source ID: | NCT02739906
|
| Associated Drug: |
Biochaperone Human Insulin (Hinsbet®)
|
| Title: |
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: BioChaperone Human Insulin (HinsBet®)|DRUG: Insulin Lispro (Humalog®)|DRUG: Regular human insulin (Huminsulin® Normal)
|
| Outcome Measures: |
Primary: BG1h, Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal, 1 hour | Secondary: ΔBG1h, Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal, 1 hour|AUCBG,0-1h, Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal, 1 hour|ΔAUCBG,0-1h, Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal, 1 hour|AUCIns,0-1h, Area under the serum insulin concentration-time curve from 0-1 hour, 1 hour|Adverse Events, Number of Adverse Events, Up to 11 weeks|Local tolerability (Number of injection site reactions), Number of injection site reactions, Up to 11 weeks
|
| Sponsor/Collaborators: |
Sponsor: Adocia
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
36
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-04
|
| Completion Date: |
2016-08
|
| Results First Posted: |
|
| Last Update Posted: |
2016-08-18
|
| Locations: |
Profil Mainz GmbH & Co.KG, Mainz, 44116, Germany|Profil GmbH, Neuss, 41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02739906
|
