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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03180710
Other study ID # BC3-CT025
Secondary ID
Status Completed
Phase Phase 1
First received June 6, 2017
Last updated January 9, 2018
Start date June 6, 2017
Est. completion date December 21, 2017

Study information

Verified date January 2018
Source Adocia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 21, 2017
Est. primary completion date August 28, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Drug:
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

Locations

Country Name City State
Germany Profil Mainz GmbH & Co. KG Mainz
Germany Profil Institut für Stoffwechselforschung GmbH Neuss

Sponsors (1)

Lead Sponsor Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC last_total 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. From 0 to 30 hours
Primary Cmax_total Maximum observed plasma insulin total concentration From 0 to 30 hours
Secondary AUCGIR 0-last (mg/kg) Area under the glucose infusion rate curve from 0 hours until the end of clamp From 0 to 30 hours
Secondary GIRmax (mg/kg/min) Maximum glucose infusion rate From 0 to 30 hours
Secondary tGIRmax Time to maximum glucose infusion rate From 0 to 30 hours
Secondary Adverse Events Up to 102 days (maximum duration of subject's participation)
Secondary Local tolerability: number of injection site reaction Frequency of injection site reaction in each arm. Up to 102 days (maximum duration of subject's participation)
Secondary Number of hypoglycaemic events in each treatment arm Up to 102 days (maximum duration of subject's participation)
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