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

A Randomised, Single Dose, Double-blind, Double-dummy, Three-period Cross-over 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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biochaperone Combo; single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: Biochaperone Combo; Injection of BioChaperone Combo; Drug: Placebo; Injection of saline 0.9% solution
Active Comparator: Humalog Mix25; single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: Placebo; Injection of saline 0.9% solution; Drug: Humalog Mix25; Injection of Humalog Mix25
Active Comparator: Humalog and Lantus; simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus	Drug: Humalog; Injection of Humalog; Drug: Lantus; Injection of Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)	Area under the glucose infusion rate curve from 12 hours to 30 hours	from 12h to 30 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCGIR 0-last (mg/kg)	Area under the glucose infusion rate curve from 0 hours until the end of clamp	Up to 30 hours
GIRmax (mg/kg/min)	Maximum glucose infusion rate	Up to 30 hours
tGIRmax	Time to maximum glucose infusion rate	Up to 30 hours
AUCLis 0-30h	Area under the insulin lispro plasma concentration time curve	Up to 30 hours
AUCGla 0-30h	Area under the insulin glargine plasma concentration time curve	Up to 30 hours
tmax Gla	Time to maximum insulin glargine plasma concentration	Up to 30 hours
tmax Lis	Time to maximum insulin lispro plasma concentration	Up to 30 hours
Adverse events	Number of adverse events	Up to 9 weeks
Hypoglycaemic episodes	Number of Hypoglycaemic episodes	Up to 9 weeks
Local tolerability	Number and intensity of injection site reactions	Up to 9 weeks

Collaborators and Investigators

• Sponsor: Adocia
• Investigators: Principal Investigator: Ulrike Hövelmann, MD, Profil Institut Für Stoffwechselfforschung GmbH

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

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-CT018