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

Adocia

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Lantus®; Drug: Humalog®; Drug: BioChaperone® Combo; Drug: Placebo; Drug: Humalog® Mix25

Study type: Interventional

Funder types: Industry

Identifiers

NCT02915250

BC3-CT022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

BioChaperone® Combo

Experimental group

Description:

Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy

Treatment:

Drug: Placebo

Drug: BioChaperone® Combo

Humalog® Mix25

Active Comparator group

Description:

Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy

Treatment:

Drug: Humalog® Mix25

Drug: Placebo

Humalog® and Lantus®

Active Comparator group

Description:

Individualised simultaneous subcutaneous injections

Treatment:

Drug: Humalog®

Drug: Lantus®