Clinical trial NCT02514850: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2015-08-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)
timeFrame: from 12h to 30 hours
Secondary outcomes:
measure: AUCGIR 0-last (mg/kg)
timeFrame: Up to 30 hours
measure: GIRmax (mg/kg/min)
timeFrame: Up to 30 hours
measure: tGIRmax
timeFrame: Up to 30 hours
measure: AUCLis 0-30h
timeFrame: Up to 30 hours
measure: AUCGla 0-30h
timeFrame: Up to 30 hours
measure: tmax Gla
timeFrame: Up to 30 hours
measure: tmax Lis
timeFrame: Up to 30 hours
measure: Adverse events
timeFrame: Up to 9 weeks
measure: Hypoglycaemic episodes
timeFrame: Up to 9 weeks
measure: Local tolerability
timeFrame: Up to 9 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut Für Stoffwechselfforschung GmbH
name: Ulrike Hövelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: