Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a single centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over, euglycaemic clamp study in subjects with type 2 diabetes on stable insulin treatment. Each subject will be randomly allocated to a treatment sequence and will be administered single subcutaneous doses of 0.8 U/kg Biochaperone® Combo, 0.8 U/kg Humalog® Mix25 or simultaneous subcutaneous injections of 0.2 U/kg Humalog® and 0.6 U/kg Lantus® during three separate dosing visits.
Interventions
DRUGBiochaperone Combo
Injection of BioChaperone Combo
DRUGHumalog Mix25
Injection of Humalog Mix25
DRUGHumalog
Injection of Humalog
DRUGLantus
Injection of Lantus
DRUGPlacebo
Injection of saline 0.9% solution
Sponsors
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months * HbA1c levels ≤ 9.0% * Total insulin dose of \< 1.2 U/kg/day * Body mass index between 20.0 and 35.0 kg/m2 (both inclusive) * Body weight ≤ 125.0 kg * Fasting serum C-peptide ≤ 1 nmol/L * Treated with a stable insulin regimen for ≥ 3 months prior to screening
Exclusion criteria
* Type 1 diabetes mellitus * Known or suspected allergy to the trial products or related products * Previous participation in this trial. Participation is defined as randomised * Participation in any clinical trial within 3 months prior to this trial * Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease * Supine blood pressure at screening outside the range of 90-160 mmHg for systolic or 50-95 mmHg for diastolic and/or resting supine heart rate outside the range 50 -90 beats per minute. This exclusion criterion also pertains to subjects being on antihypertensives * Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin within 4 weeks prior to screening * Women of child bearing potential, not willing to use contraceptive methods
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg) | from 12h to 30 hours | Area under the glucose infusion rate curve from 12 hours to 30 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GIRmax (mg/kg/min) | Up to 30 hours | Maximum glucose infusion rate |
| tGIRmax | Up to 30 hours | Time to maximum glucose infusion rate |
| AUCLis 0-30h | Up to 30 hours | Area under the insulin lispro plasma concentration time curve |
| AUCGla 0-30h | Up to 30 hours | Area under the insulin glargine plasma concentration time curve |
| AUCGIR 0-last (mg/kg) | Up to 30 hours | Area under the glucose infusion rate curve from 0 hours until the end of clamp |
| tmax Lis | Up to 30 hours | Time to maximum insulin lispro plasma concentration |
| Adverse events | Up to 9 weeks | Number of adverse events |
| Hypoglycaemic episodes | Up to 9 weeks | Number of Hypoglycaemic episodes |
| Local tolerability | Up to 9 weeks | Number and intensity of injection site reactions |
| tmax Gla | Up to 30 hours | Time to maximum insulin glargine plasma concentration |
Countries
Germany
Outcome results
None listed