A Trial to Investigate the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
NCT ID: NCT03180710
Last Updated: 2018-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2017-06-06
2017-12-21
Brief Summary
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Detailed Description
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Each subject will be randomly allocated to a sequence of four treatments, three single doses of BioChaperone® Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) and one single dose of Humalog® Mix25 at 0.8 U/kg on four 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 30-hour clamp procedures have been terminated.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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BioChaperone® Combo 75/25 at 0.6 U/kg
Single subcutaneous injection of 0.6 U/kg
BioChaperone® Combo 75/25 at 0.6 U/kg
Injection of BioChaperone® Combo 75/25 at 0.6 U/kg
BioChaperone® Combo 75/25 at 0.8 U/kg
Single subcutaneous dose of 0.8 U/kg
BioChaperone® Combo 75/25 at 0.8 U/kg
Injection of BioChaperone® Combo 75/25 at 0.8 U/kg
BioChaperone® Combo 75/25 at 1.0 U/kg
Single subcutaneous dose of 1.0 U/kg
BioChaperone® Combo 75/25 at 1.0 U/kg
Injection of BioChaperone® Combo 75/25 at 1.0 U/kg
Humalog® Mix25 at 0.8 U/kg
Single subcutaneous dose of 0.8 U/kg
Humalog® Mix25 at 0.8 U/kg
Injection of Humalog® Mix25 at 0.8 U/kg
Interventions
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BioChaperone® Combo 75/25 at 0.6 U/kg
Injection of BioChaperone® Combo 75/25 at 0.6 U/kg
BioChaperone® Combo 75/25 at 0.8 U/kg
Injection of BioChaperone® Combo 75/25 at 0.8 U/kg
BioChaperone® Combo 75/25 at 1.0 U/kg
Injection of BioChaperone® Combo 75/25 at 1.0 U/kg
Humalog® Mix25 at 0.8 U/kg
Injection of Humalog® Mix25 at 0.8 U/kg
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
* HbA1c level between 6.5% and 9.0 % (both inclusive)
* Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
* Body weight \<= 125.0 kg at the screening visit
* Insulin-treated subjects. Total insulin dose of \<= 1.2 (I)U/kg/day
Exclusion Criteria
* Known or suspected hypersensitivity to IMP(s) or related products
* Previous participation in this trial. Participation is defined as randomised.
* Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
* Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
* Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the range of 90-160 mmHg systolically or 50-95 mmHg diastolically (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial); symptoms of arterial hypotension and/or a heart rate at rest outside the range of 50-90 beats per minute. This exclusion criterion also pertains to subjects being on anti-hypertensives.
* Women of child bearing potential not willing to use contraceptive methods.
18 Years
70 Years
ALL
No
Sponsors
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Adocia
INDUSTRY
Responsible Party
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Principal Investigators
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Oliver Klein, MD
Role: PRINCIPAL_INVESTIGATOR
Profil Institut für Stoffwechselforschung GmbH
Locations
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Profil Mainz GmbH & Co. KG
Mainz, , Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, , Germany
Countries
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Other Identifiers
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BC3-CT025
Identifier Type: -
Identifier Source: org_study_id
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