Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGBioChaperone® Combo 75/25 at 0.6 U/kg
Injection of BioChaperone® Combo 75/25 at 0.6 U/kg
DRUGBioChaperone® Combo 75/25 at 0.8 U/kg
Injection of BioChaperone® Combo 75/25 at 0.8 U/kg
DRUGBioChaperone® Combo 75/25 at 1.0 U/kg
Injection of BioChaperone® Combo 75/25 at 1.0 U/kg
DRUGHumalog® Mix25 at 0.8 U/kg
Injection of Humalog® Mix25 at 0.8 U/kg
Sponsors
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Cmax_total | From 0 to 30 hours | Maximum observed plasma insulin total concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tGIRmax | From 0 to 30 hours | Time to maximum glucose infusion rate |
| Adverse Events | 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 |
| Number of hypoglycaemic events in each treatment arm | Up to 102 days (maximum duration of subject's participation) | — |
| 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. |
| GIRmax (mg/kg/min) | From 0 to 30 hours | Maximum glucose infusion rate |
Countries
Germany
Outcome results
None listed