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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: BioChaperone® Combo 75/25 at 0.6 U/kg; Drug: BioChaperone® Combo 75/25 at 0.8 U/kg; Drug: BioChaperone® Combo 75/25 at 1.0 U/kg; Drug: Humalog® Mix25 at 0.8 U/kg

• Registration Number: NCT03180710
• Lead Sponsor: Adocia

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.

Study Timeline

• Study Start: 2017-06-06
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-08
• Primary Completion: 2017-08-28
• Study Completion: 2017-12-21
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BioChaperone® Combo 75/25 at 0.6 U/kg	BioChaperone® Combo 75/25 at 0.6 U/kg	Single subcutaneous injection of 0.6 U/kg
BioChaperone® Combo 75/25 at 0.8 U/kg	BioChaperone® Combo 75/25 at 0.8 U/kg	Single subcutaneous dose of 0.8 U/kg
BioChaperone® Combo 75/25 at 1.0 U/kg	BioChaperone® Combo 75/25 at 1.0 U/kg	Single subcutaneous dose of 1.0 U/kg
Humalog® Mix25 at 0.8 U/kg	Humalog® Mix25 at 0.8 U/kg	Single subcutaneous dose of 0.8 U/kg

Primary Outcome Measures

Name	Time	Method
Cmax_total	From 0 to 30 hours	Maximum observed plasma insulin total concentration
AUC last_total	From 0 to 30 hours	Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Up to 102 days (maximum duration of subject's participation)
GIRmax (mg/kg/min)	From 0 to 30 hours	Maximum glucose infusion rate
tGIRmax	From 0 to 30 hours	Time to maximum glucose infusion rate
Local tolerability: number of injection site reaction	Up to 102 days (maximum duration of subject's participation)	Frequency of injection site reaction in each arm.
Number of hypoglycaemic events in each treatment arm	Up to 102 days (maximum duration of subject's participation)
AUCGIR 0-last (mg/kg)	From 0 to 30 hours	Area under the glucose infusion rate curve from 0 hours until the end of clamp

Trial Locations

Locations (2)

Profil Mainz GmbH & Co. KG; 🇩🇪 Mainz, Germany

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany