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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514850
• Other study ID #: BC3-CT018
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2015
• Last updated: November 30, 2015
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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 saline 0.9% solution

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	AUCGIR 0-last (mg/kg)	Area under the glucose infusion rate curve from 0 hours until the end of clamp	Up to 30 hours	No
Secondary	GIRmax (mg/kg/min)	Maximum glucose infusion rate	Up to 30 hours	No
Secondary	tGIRmax	Time to maximum glucose infusion rate	Up to 30 hours	No
Secondary	AUCLis 0-30h	Area under the insulin lispro plasma concentration time curve	Up to 30 hours	No
Secondary	AUCGla 0-30h	Area under the insulin glargine plasma concentration time curve	Up to 30 hours	No
Secondary	tmax Gla	Time to maximum insulin glargine plasma concentration	Up to 30 hours	No
Secondary	tmax Lis	Time to maximum insulin lispro plasma concentration	Up to 30 hours	No
Secondary	Adverse events	Number of adverse events	Up to 9 weeks	Yes
Secondary	Hypoglycaemic episodes	Number of Hypoglycaemic episodes	Up to 9 weeks	Yes
Secondary	Local tolerability	Number and intensity of injection site reactions	Up to 9 weeks	Yes