A Trial to Compare Post Prandial Blood Glucose Control of BioChaperone® Combo With Humalog® Mix25 and With Simultaneous Injections of Humalog® and Lantus® in Subjects With Type 2 Diabetes
NCT ID: NCT02915250
Last Updated: 2017-06-29
Study Results
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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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2016-10-31
2017-06-30
Brief Summary
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Detailed Description
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Furthermore, this study aims to compare the pharmacokinetic (PK) profiles of the three different study treatments.
During each dosing visit, subjects will be given 3 doses of IMP on three consecutive days (Day 1, Day 2 and Day 3). Dosing on Day 2 and Day 3 will be followed by a standardised solid meal test.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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BioChaperone® Combo
Individualised single subcutaneous of BioChaperone® Combo + injection of placebo (0.9% NaCl) to ensure the double dummy
BioChaperone® Combo
Injection of BioChaperone® Combo
Placebo
Injection of 0.9% NaCl
Humalog® Mix25
Individualised single subcutaneous of Humalog® Mix25 + injection of placebo (0.9% NaCl) to ensure the double dummy
Humalog® Mix25
Injection of Humalog® Mix25
Placebo
Injection of 0.9% NaCl
Humalog® and Lantus®
Individualised simultaneous subcutaneous injections
Humalog®
Injection of Humalog®
Lantus®
Injection of Lantus®
Interventions
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BioChaperone® Combo
Injection of BioChaperone® Combo
Humalog® Mix25
Injection of Humalog® Mix25
Humalog®
Injection of Humalog®
Lantus®
Injection of Lantus®
Placebo
Injection of 0.9% NaCl
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
* HbA1c level between 7.5% and 9.5% (both inclusive)
* Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
* Treated with once daily injections with insulin glargine U-100 for ≥ 3 months prior to screening
Exclusion Criteria
* Known or suspected allergy to the IMPs or related products
* Previous participation in this trial. Participation is defined as randomised.
* Receipt of any medicinal product in clinical development within 60 days prior to this trial.
* Clinically significant abnormal haematology, biochemistry, urinalysis or coagulation 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.
* Current treatment with premixed or intermediate insulin products, or with long acting insulins other than insulin glargine U-100. The use of short or rapid acting prandial insulin products will be allowed provided their use has been stable for ≥ 3 months prior to screening.
* Use of GLP-1 receptor agonists or oral antidiabetic drugs (OADs) other than stable intake of metformin alone or metformin in combination with a DPP-4 inhibitor within 4 weeks prior to screening
* Women of child bearing potential not willing to use contraceptive methods.
18 Years
70 Years
ALL
No
Sponsors
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Adocia
INDUSTRY
Responsible Party
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Principal Investigators
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Leona Plum-Mörschel, MD
Role: PRINCIPAL_INVESTIGATOR
Profil Mainz GmbH & Co KG
Locations
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Profil Mainz GmbH & Co.KG
Mainz, , Germany
Profil GmbH
Neuss, , Germany
Countries
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Other Identifiers
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BC3-CT022
Identifier Type: -
Identifier Source: org_study_id