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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915250
• Other study ID #: BC3-CT022
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2016
• Last updated: June 28, 2017
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• BioChaperone® Combo
Injection of BioChaperone® Combo
• Humalog® Mix25
Injection of Humalog® Mix25
• Humalog®
Injection of Humalog®
• Lantus®
Injection of Lantus®
• Placebo
Injection of 0.9% NaCl

Locations

Country	Name	City	State
Germany	Profil Mainz GmbH & Co.KG	Mainz
Germany	Profil GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)	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	From 0 to 2 hours
Secondary	Partial delta AUCs BG and total AUCs BG	Partial incremental AUCs BG and total AUCs BG in the 0-6 time range	From 0 to 6 hours
Secondary	Mean and mean change from baseline of blood glucose at different time points		From 0 to 6 hours
Secondary	Delta BGmax and delta BGmin	Maximum and minimum blood glucose excursions after a standardised meal	From 0 to 6 hours
Secondary	BGmax and BGmin	Maximum and minimum blood glucose concentrations after a standardised meal	From 0 to 6 hours
Secondary	AUC Insulin	Partial areas under the insulins plasma concentration time curve	From 0 to 24 hours
Secondary	Cmax Insulin	Maximum observed plasma insulins concentration	From 0 to 6 hours
Secondary	tmax Insulin	Time to maximum observed plasma insulins concentration	From 0 to 6 hours
Secondary	Adverse Events		Up to 12 weeks (maximum duration of subject's participation)
Secondary	Local tolerability		Up to 12 weeks (maximum duration of subject's participation)
Secondary	Hypoglycaemic events		Up to 12 weeks (maximum duration of subject's participation)