NCT05373199 is a Phase 1 clinical trial of Euglycemic clamp with BC Combo THDB0207 in Type 1 Diabetes, sponsored by Adocia.

Who is sponsoring NCT05373199?

NCT05373199 is sponsored by Adocia.

What drugs are being tested in NCT05373199?

Interventions in NCT05373199: Euglycemic clamp with BC Combo THDB0207, Euglycemic clamp with Lantus®, Euglycemic clamp with Humalog®.

What condition does NCT05373199 study?

NCT05373199 studies Type 1 Diabetes.

Is NCT05373199 still recruiting?

NCT05373199 is currently completed. Last updated 15 September 2023.

Last reviewed 2023-09-15 · How we verify

NCT05373199

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects With Type 1 Diabetes

Completed Phase 1 Last updated 15 September 2023

What this trial tests

Phase 1 trial testing Euglycemic clamp with BC Combo THDB0207 in Type 1 Diabetes in 30 participants. Completed in 28 October 2022.

Timeline

12 May 2022

Primary endpoint
28 October 2022

28 October 2022

Quick facts

Lead sponsor	Adocia
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	12 May 2022
Primary completion	28 October 2022
Estimated completion	28 October 2022
Sites	1 location across Germany

Drugs / interventions tested

Euglycemic clamp with BC Combo THDB0207 — full drug profile →
Euglycemic clamp with Lantus® — full drug profile →
Euglycemic clamp with Humalog® — full drug profile →

Conditions studied

Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Adocia — full company profile →

Who can join

Adults 18 to 64, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomised, double-blind, three-period crossover euglycaemic clamp trial comparing pharmacokinetics and pharmacodynamics of BC Combo THDB0207 and Lantus® and Humalog® in subjects with type 1 diabetes. Each subject will be randomly allocated to one of the 6 treatment sequences and will be administered single subcutaneous doses of BC Combo THDB0207, Lantus®, and Humalog® at three separate dosing visits. Subjects will come in a fasted state to the clinical trial centre in the morning of each dosing day and stay at the clinical trial centre until the 24-hour clamp procedures have been terminated. Patients will return to the clinical trial centre for outpatient blood sampling visits for analysis of BC449 excipient until 144 hours after each dosing.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Euglycemic clamp with BC Combo THDB0207

Trials testing the same drug.

NCT05373186 — A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections · Phase 1 · completed
NCT05373212 — A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes · Phase 1 · completed

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting

Other Adocia trials

Trials by the same sponsor.

NCT05373186 — A Trial Investigating the Pharmacodynamics of BC Combo THDB0207 Compared With Humalog® Mix25 and Simultaneous Injections · Phase 1 · completed
NCT05373212 — A Trial Investigating the Dose Linearity and Safety of BC Combo THDB0207 in Subjects With Type 2 Diabetes · Phase 1 · completed
NCT04816890 — A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM) · Phase 2 · completed
NCT04501107 — A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in P · Phase 1 · completed
NCT03981627 — A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05373199 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Adocia
Last refreshed: 15 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05373199.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing