Clinical trial NCT03180710: 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
Official title: A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-linearity of BioChaperone® Combo 75/25 and the Safety at Three Different Doses in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

Detailed description: This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

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.

Eligibility criteria: Inclusion Criteria:

* Male or female subject aged 18-70 years (both inclusive)
* 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:

* Type 1 diabetes mellitus
* 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.

Primary outcomes:
measure: AUC last_total
timeFrame: From 0 to 30 hours
measure: Cmax_total
timeFrame: From 0 to 30 hours
Secondary outcomes:
measure: AUCGIR 0-last (mg/kg)
timeFrame: From 0 to 30 hours
measure: GIRmax (mg/kg/min)
timeFrame: From 0 to 30 hours
measure: tGIRmax
timeFrame: From 0 to 30 hours
measure: Adverse Events
timeFrame: Up to 102 days (maximum duration of subject's participation)
measure: Local tolerability: number of injection site reaction
timeFrame: Up to 102 days (maximum duration of subject's participation)
measure: Number of hypoglycaemic events in each treatment arm
timeFrame: Up to 102 days (maximum duration of subject's participation)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH & Co. KG
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Oliver Klein, MD
role: PRINCIPAL_INVESTIGATOR
References: