Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits.
Detailed description
This is a two-centre, randomised, double-blind, double-dummy, 3-treatment, 3-period cross-over study using a standardised solid meal test in subjects with type 2 diabetes to investigate postprandial glucose control of BioChaperone® Combo compared with Humalog® Mix25 and with simultaneous subcutaneous injections of Humalog® and Lantus® during three separate dosing visits. Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments. During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.
Interventions
Injection of BioChaperone® Combo
DRUGHumalog® Mix25
Injection of Humalog® Mix25
DRUGHumalog®
Injection of Humalog®
DRUGLantus®
Injection of Lantus®
DRUGPlacebo
Injection of 0.9% NaCl
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 7.5% and 9.5% (both inclusive) * Body mass index between 20.0 and 40.0 kg/m2 (both inclusive) * Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening
Exclusion criteria
* Type 1 diabetes mellitus * Known or suspected allergy to the IMPs or related products * Previous participation in this trial. Participation is defined as randomised. * Receipt of any medicinal product in clinical development within 60 days prior to this trial. * Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation 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. * Current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine U-100. The use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening. * Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin alone or metformin in combination with a DPP-4 inhibitor within 4 weeks prior to screening * Women of child bearing potential not willing to use contraceptive methods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta AUC BG 0-2h (area under the blood glucose concentration-time curve) | From 0 to 2 hours | Mean of incremental areas under the blood glucose concentration-time curve from 0-2 hours after a standardised meal on Day 2 and Day 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean and mean change from baseline of blood glucose at different time points | From 0 to 6 hours | — |
| Delta BGmax and delta BGmin | From 0 to 6 hours | Maximum and minimum blood glucose excursions after a standardised meal |
| BGmax and BGmin | From 0 to 6 hours | Maximum and minimum blood glucose concentrations after a standardised meal |
| AUC Insulin | From 0 to 24 hours | Partial areas under the insulins plasma concentration time curve |
| Partial delta AUCs BG and total AUCs BG | From 0 to 6 hours | Partial incremental AUCs BG and total AUCs BG in the 0-6 time range |
| tmax Insulin | From 0 to 6 hours | Time to maximum observed plasma insulins concentration |
| Adverse Events | Up to 12 weeks (maximum duration of subject's participation) | — |
| Local tolerability | Up to 12 weeks (maximum duration of subject's participation) | — |
| Hypoglycaemic events | Up to 12 weeks (maximum duration of subject's participation) | — |
| Cmax Insulin | From 0 to 6 hours | Maximum observed plasma insulins concentration |
Countries
Germany
Outcome results
None listed