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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Biochaperone Combo; Drug: Humalog Mix25; Drug: Humalog; Drug: Placebo; Drug: Lantus

• Registration Number: NCT02514850
• Lead Sponsor: Adocia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-04
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biochaperone Combo	Biochaperone Combo	single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
Humalog Mix25	Placebo	single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
Humalog and Lantus	Lantus	simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus
Humalog Mix25	Humalog Mix25	single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
Biochaperone Combo	Placebo	single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
Humalog and Lantus	Humalog	simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)	from 12h to 30 hours	Area under the glucose infusion rate curve from 12 hours to 30 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany