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

Adocia

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Humalog® Mix25 at 0.8 U/kg; Drug: BioChaperone® Combo 75/25 at 1.0 U/kg; Drug: BioChaperone® Combo 75/25 at 0.6 U/kg; Drug: BioChaperone® Combo 75/25 at 0.8 U/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03180710

BC3-CT025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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32 participants in 4 patient groups

BioChaperone® Combo 75/25 at 0.6 U/kg

Experimental group

Description:

Single subcutaneous injection of 0.6 U/kg

Treatment:

Drug: BioChaperone® Combo 75/25 at 0.6 U/kg

BioChaperone® Combo 75/25 at 0.8 U/kg

Experimental group

Description:

Single subcutaneous dose of 0.8 U/kg

Treatment:

Drug: BioChaperone® Combo 75/25 at 0.8 U/kg

BioChaperone® Combo 75/25 at 1.0 U/kg

Experimental group

Description:

Single subcutaneous dose of 1.0 U/kg

Treatment:

Drug: BioChaperone® Combo 75/25 at 1.0 U/kg

Humalog® Mix25 at 0.8 U/kg

Active Comparator group

Description:

Single subcutaneous dose of 0.8 U/kg

Treatment:

Drug: Humalog® Mix25 at 0.8 U/kg