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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: BioChaperone® Combo; Drug: Humalog® Mix25; Drug: Humalog®; Drug: Lantus®

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55116
    • Profil Mainz GmbH & Co.KG
  • Neuss, Germany, 41460
    • Profil GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioChaperone® Combo; Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: Placebo; Injection of 0.9% NaCl; Drug: BioChaperone® Combo; Injection of BioChaperone® Combo
Active Comparator: Humalog® Mix25; Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: Placebo; Injection of 0.9% NaCl; Drug: Humalog® Mix25; Injection of Humalog® Mix25
Active Comparator: Humalog® and Lantus®; Individualised simultaneous subcutaneous injections	Drug: Humalog®; Injection of Humalog®; Drug: Lantus®; Injection of Lantus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mean and mean change from baseline of blood glucose at different time points		From 0 to 6 hours
Delta BGmax and delta BGmin	Maximum and minimum blood glucose excursions after a standardised meal	From 0 to 6 hours
BGmax and BGmin	Maximum and minimum blood glucose concentrations after a standardised meal	From 0 to 6 hours
AUC Insulin	Partial areas under the insulins plasma concentration time curve	From 0 to 24 hours
Cmax Insulin	Maximum observed plasma insulins concentration	From 0 to 6 hours
tmax Insulin	Time to maximum observed plasma insulins concentration	From 0 to 6 hours
Adverse Events		Up to 12 weeks (maximum duration of subject's participation)
Local tolerability		Up to 12 weeks (maximum duration of subject's participation)
Hypoglycaemic events		Up to 12 weeks (maximum duration of subject's participation)

Collaborators and Investigators

• Sponsor: Adocia
• Investigators: Principal Investigator: Leona Plum-Mörschel, MD, Profil Mainz GmbH & Co KG

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimate): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: BC3-CT022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO