Clinical trial NCT02915250: 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
Official title: A Randomised, Double-blind, Double-dummy, Three-period Cross-over 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)
timeFrame: From 0 to 2 hours
Secondary outcomes:
measure: Partial delta AUCs BG and total AUCs BG
timeFrame: From 0 to 6 hours
measure: Mean and mean change from baseline of blood glucose at different time points
timeFrame: From 0 to 6 hours
measure: Delta BGmax and delta BGmin
timeFrame: From 0 to 6 hours
measure: BGmax and BGmin
timeFrame: From 0 to 6 hours
measure: AUC Insulin
timeFrame: From 0 to 24 hours
measure: Cmax Insulin
timeFrame: From 0 to 6 hours
measure: tmax Insulin
timeFrame: From 0 to 6 hours
measure: Adverse Events
timeFrame: Up to 12 weeks (maximum duration of subject's participation)
measure: Local tolerability
timeFrame: Up to 12 weeks (maximum duration of subject's participation)
measure: Hypoglycaemic events
timeFrame: Up to 12 weeks (maximum duration of subject's participation)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH & Co.KG
city: Neuss
country: Germany
facility: Profil GmbH
Study officials:
affiliation: Profil Mainz GmbH & Co KG
name: Leona Plum-Mörschel, MD
role: PRINCIPAL_INVESTIGATOR
References: