NCT02529293 is a Phase 1 clinical trial of BioChaperone Lispro U-100 in Healthy, sponsored by Adocia.

Who is sponsoring NCT02529293?

NCT02529293 is sponsored by Adocia.

What drugs are being tested in NCT02529293?

Interventions in NCT02529293: BioChaperone Lispro U-100, BioChaperone Lispro U-200.

Is NCT02529293 still recruiting?

NCT02529293 is currently completed. Last updated 17 December 2015.

Last reviewed 2015-12-17 · How we verify

NCT02529293

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

A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female

Completed Phase 1 Last updated 17 December 2015

What this trial tests

Phase 1 trial testing BioChaperone Lispro U-100 in Healthy in 26 participants. Completed in 1 November 2015.

Timeline

1 August 2015

Primary endpoint
1 November 2015

1 November 2015

Quick facts

Lead sponsor	Adocia
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	26
Start date	1 August 2015
Primary completion	1 November 2015
Estimated completion	1 November 2015
Sites	1 location across Germany

Drugs / interventions tested

BioChaperone Lispro U-100 — full drug profile →
BioChaperone Lispro U-200 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Adocia — full company profile →

Who can join

Adults 18 to 64, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

AUCLisp (0-inf)
Time frame: 8 hours
Area under the insulin lispro serum concentration - time curve from t=0 to infinity
Cmax Lisp
Time frame: 8 hours
Maximum observed insulin lispro serum concentration

Sponsor's own description

This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects. Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.

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:

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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
NCT05373199 — A Trial Comparing the Pharmacodynamics and Pharmacokinetics of BC Combo THDB0207 and Lantus® and Humalog® in Subjects Wi · 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

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 NCT02529293 (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: 17 December 2015

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/NCT02529293.

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