A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02915250
- Lead Sponsor
- Adocia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Humalog® and Lantus® Lantus® Individualised simultaneous subcutaneous injections Humalog® Mix25 Humalog® Mix25 Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy Humalog® Mix25 Placebo Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy BioChaperone® Combo BioChaperone® Combo Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy BioChaperone® Combo Placebo Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy Humalog® and Lantus® Humalog® Individualised simultaneous subcutaneous injections
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cmax Insulin From 0 to 6 hours Maximum observed plasma insulins concentration
Mean and mean change from baseline of blood glucose at different time points From 0 to 6 hours AUC Insulin From 0 to 24 hours Partial areas under the insulins plasma concentration time curve
Delta BGmax and delta BGmin From 0 to 6 hours Maximum and minimum blood glucose excursions after a standardised meal
tmax Insulin From 0 to 6 hours Time to maximum observed plasma insulins concentration
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
BGmax and BGmin From 0 to 6 hours Maximum and minimum blood glucose concentrations after a standardised meal
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)
Trial Locations
- Locations (2)
Profil Mainz GmbH & Co.KG
🇩🇪Mainz, Germany
Profil GmbH
🇩🇪Neuss, Germany