A Trial to Compare the Pharmacodynamic and Pharmacokinetic Properties 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: Biochaperone Combo; Drug: Lantus; Drug: Humalog Mix25; Drug: Humalog; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02514850

BC3-CT018

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Biochaperone Combo

Experimental group

Description:

single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy

Treatment:

Drug: Placebo

Drug: Biochaperone Combo

Humalog Mix25

Active Comparator group

Description:

single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy

Treatment:

Drug: Humalog Mix25

Drug: Placebo

Humalog and Lantus

Active Comparator group

Description:

simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus

Treatment:

Drug: Lantus

Drug: Humalog