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

NCT02514850 | Completed Phase 1

• 1 other identifier: BC3-CT018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• AUCGIR 0-last (mg/kg)

  Up to 30 hours

• GIRmax (mg/kg/min)

  Up to 30 hours

• tGIRmax

  Up to 30 hours

• AUCLis 0-30h

  Up to 30 hours

• AUCGla 0-30h

  Up to 30 hours

Study Arms (3)

Biochaperone Combo

EXPERIMENTAL

single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy

Drug: Biochaperone Combo; Drug: Placebo

Humalog Mix25

ACTIVE COMPARATOR

single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy

Drug: Humalog Mix25; Drug: Placebo

Humalog and Lantus

ACTIVE COMPARATOR

simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus

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 saline 0.9% solution

Biochaperone Combo; Humalog Mix25

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin lispro, isophane insulin lispro drug combination (25:75); 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

• Ulrike Hövelmann, MD

  Profil Institut Für Stoffwechselfforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 4, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

DE (1)