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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

NCT ID: NCT02514850

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Biochaperone Combo

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

Group Type EXPERIMENTAL

Biochaperone Combo

Intervention Type DRUG

Injection of BioChaperone Combo

Placebo

Intervention Type DRUG

Injection of saline 0.9% solution

Humalog Mix25

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

Group Type ACTIVE_COMPARATOR

Humalog Mix25

Intervention Type DRUG

Injection of Humalog Mix25

Placebo

Intervention Type DRUG

Injection of saline 0.9% solution

Humalog and Lantus

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

Group Type ACTIVE_COMPARATOR

Humalog

Intervention Type DRUG

Injection of Humalog

Lantus

Intervention Type DRUG

Injection of Lantus

Interventions

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Biochaperone Combo

Injection of BioChaperone Combo

Intervention Type DRUG

Humalog Mix25

Injection of Humalog Mix25

Intervention Type DRUG

Humalog

Injection of Humalog

Intervention Type DRUG

Lantus

Injection of Lantus

Intervention Type DRUG

Placebo

Injection of saline 0.9% solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adocia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrike Hövelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut Für Stoffwechselfforschung GmbH

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BC3-CT018

Identifier Type: -

Identifier Source: org_study_id