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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adocia
• Treatments: Biphasic Insulins; Insulin Glargine; Insulin Lispro; Insulin, Isophane

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.