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

NCT02915250 | Completed Phase 1

• 1 other identifier: BC3-CT022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Partial delta AUCs BG and total AUCs BG

  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

  From 0 to 6 hours

• BGmax and BGmin

  From 0 to 6 hours

• AUC Insulin

  From 0 to 24 hours

Study Arms (3)

BioChaperone® Combo

EXPERIMENTAL

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

Drug: BioChaperone® Combo; Drug: Placebo

Humalog® Mix25

ACTIVE COMPARATOR

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

Drug: Humalog® Mix25; Drug: Placebo

Humalog® and Lantus®

ACTIVE COMPARATOR

Individualised simultaneous subcutaneous injections

Drug: Humalog®; Drug: Lantus®

Interventions

BioChaperone® Combo DRUG

Injection of BioChaperone® Combo

BioChaperone® Combo

Humalog® Mix25 DRUG

Injection of Humalog® Mix25

Humalog® Mix25

Humalog® DRUG

Injection of Humalog®

Humalog® and Lantus®

Lantus® DRUG

Injection of Lantus®

Humalog® and Lantus®

Placebo DRUG

Injection of 0.9% NaCl

BioChaperone® Combo; Humalog® Mix25

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Adocia: lead

Study Sites (2)

Profil Mainz GmbH & Co.KG

Mainz, 55116, Germany

Location

Profil GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Leona Plum-Mörschel, MD

  Profil Mainz GmbH & Co KG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 26, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)