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COMPLETEDPhase 1NCT02344992

Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insul...

Lead sponsor: Adocia•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Adocia

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Type 1 Diabetes Mellitus ≥ 12 months
•Treated with multiple daily insulin injections or CSII ≥ 12 months
•BMI 18.5-28.0 kg/m² (both inclusive)
•HbA1C%≤9%

Exclusion Criteria

•Type 2 Diabetes Mellitus
•Receipt of any trial product within 60 days prior to this trial
•Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
•Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
•Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
•Any systemic treatment with drugs known to interfere with glucose metabolism
•Use of any tobacco or nicotine-contained product within one year prior to screening

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 1, 2017Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment38

Start dateJan 2015

Last updatedJun 1, 2017

Condition

Diabetes Mellitus Type 1

Locations shown

Profil GmbH

Neuss

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2017Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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