Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2540
Source ID: NCT05373212
Associated Drug: Euglycemic Clamp With Bc Combo Thdb0207
Title: A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Euglycemic clamp with BC Combo THDB0207|DRUG: Euglycemic clamp with Humalog® Mix25
Outcome Measures: Primary: AUCTOTAL0-last, Area under the total insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ, From t=0 to t=30 hours after IMP administration|CmaxTOTAL, Maximum total insulin concentration, From t=0 to t=30 hours after IMP administration | Secondary: AUCGIR 0-last, Area under the glucose infusion rate curve from 0 hours until the end of clamp, From t=0 to t=30 hours after IMP administration|GIRmax, Maximum glucose infusion rate, From t=0 to t=30 hours after IMP administration|tGIRmax, Time to maximum glucose infusion rate, From t=0 to t=30 hours after IMP administration|Tonset of action, Time until Plasma Glucose (PG) has decreased by at least 5 mg/dL from the baseline PG value., From t=0 to t=30 hours after IMP administration|AUCGIR 0-6h, Area under the glucose infusion rate curve from t=0 hours to t=6 hours, From t=0 to t=6 hours|AUCTOTALlast, Area under the insulin concentration-time curve from t=0 to the last measured insulin concentration above LLOQ, From t=0 to t=30 hours after IMP administration|AUCTOTAL 0-1h, Area under the total insulin concentration-time curve from t=0 to t=1 hour, From t=0 to t=1 hour|AUCTOTAL 0-2h, Area under the total insulin concentration-time curve from t=0 to t=2 hours, From t=0 to t=2 hours|AUCTOTAL 0-6h, Area under the total insulin concentration-time curve from t=0 to t=6 hours, From t=0 to t=6 hours|AUCTOTAL 2-6h, Area under the total insulin concentration-time curve from t=2 to t=6 hours, From t=2 to t=6 hours|AUCTOTAL 6-12h, Area under the total insulin concentration-time curve from t=6 to t=12 hours, From t=6 to t=12 hours|AUCTOTAL 6-24h, Area under the total insulin concentration-time curve from t=6 to t=24 hours, From t=6 to t=24 hours|AUCTOTAL 12-24h, Area under the total insulin concentration-time curve from t=12 to t=24 hours, From t=12 to t=24 hours|AUCTOTAL 12-30h, Area under the total insulin concentration-time curve from t=12 to t=30 hours, From t=12 to t=30 hours|AUCTOTAL 0-30h, Area under the total insulin concentration-time curve from t=0 to t=30 hours, From t=0 to t=30 hours|CTOTALmax, Maximum insulin concentration, From t=0 to t=30 hours after IMP administration|tmaxTOTAL, Time to maximum total insulin concentration, From t=0 to t=30 hours after IMP administration|AUCGLA 0-last, Area under the insulin glargine concentration-time curve from t=0 to the last measured insulin concentration above LLOQ, From t=0 to t=30 hours after IMP administration|AUCGLA 0-1h, Area under the insulin glargine concentration-time curve from t=0 to t=1 hour, From t=0 to t=1 hour after IMP administration|AUCGLA 0-2h, Area under the insulin glargine concentration-time curve from t=0 to t=2 hours, From t=0 to t=2 hours after IMP administration|AUCGLA 0-6h, Area under the insulin glargine concentration-time curve from t=0 to t=6 hours, From t=0 to t=6 hours after IMP administration|AUCGLA 2-6h, Area under the insulin glargine concentration-time curve from t=2 to t=6 hours, From t=2 to t=6 hours after IMP administration|AUCGLA 6-12h, Area under the insulin glargine concentration-time curve from t=6 to t=12 hours, From t=6 to t=12 hours after IMP administration|AUCGLA 12-24h, Area under the insulin glargine concentration-time curve from t=12 to t=24 hours, From t=12 to t=24 hours after IMP administration|AUCGLA 12-30h, Area under the insulin glargine concentration-time curve from t=12 to t=30 hours, From t=12 to t=30 hours after IMP administration|AUCGLA 0-30h, Area under the insulin glargine concentration-time curve from t=0 to t=30 hours, From t=0 to t=30 hours after IMP administration|CmaxGLA, Maximum concentration of insulin glargine, From t=0 to t=30 hours after IMP administration|tmaxGLA, Time to maximum insulin glargine concentration, From t=0 to t=30 hours after IMP administration|AUCLIS0-last, Area under the insulin lispro concentration-time curve from t=0 to the last measured insulin concentration above LLOQ, From t=0 to t=30 hours after IMP administration|AUCLIS 0-1h, Area under the insulin lispro concentration-time curve from t=0 to t=1 hour, From t=0 to t=1 hour after IMP administration|AUCLIS 0-2h, Area under the insulin lispro concentration-time curve from t=0 to t=2 hours, From t=0 to t=2 hours after IMP administration|AUCLIS 0-6h, Area under the insulin lispro concentration-time curve from t=0 to t=6 hours, From t=0 to t=6 hours after IMP administration|AUCLIS 2-6h, Area under the insulin lispro concentration-time curve from t=2 to t=6 hours, From t=2 to t=6 hours after IMP administration|AUCLIS 6-12h, Area under the insulin lispro concentration-time curve from t=6 to t=12 hours, From t=6 to t=12 hours after IMP administration|AUCLIS 12-24h, Area under the insulin lispro concentration-time curve from t=12 to t=24 hours, From t=12 to t=24 hours after IMP administration|AUCLIS 12-30h, Area under the insulin lispro concentration-time curve from t=12 to t=30 hours, From t=12 to t=30 hours after IMP administration|AUCLIS 0-30h, Area under the insulin lispro concentration-time curve from t=0 to t=30 hours, From t=0 to t=30 hours after IMP administration|CmaxLIS, Maximum concentration of insulin lispro, From t=0 to t=30 hours after IMP administration|tmaxLIS, Time to maximum insulin lispro concentration, From t=0 to t=30 hours after IMP administration|Adverse Events, Incidence of Adverse Events, From the first IMP administration to the follow-up visit (i.e. up to 14 weeks)|Local tolerability, Incidence of Injection Site Reactions, From the first IMP administration to the follow-up visit (i.e. up to 14 weeks)
Sponsor/Collaborators: Sponsor: Adocia | Collaborators: Tonghua Dongbao Pharmaceutical Co.,Ltd
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-05-12
Completion Date: 2023-01-02
Results First Posted:
Last Update Posted: 2023-09-15
Locations: Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT05373212