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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

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ClinicalTrials.gov Identifier: NCT02514850
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Adocia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Biochaperone Combo Drug: Humalog Mix25 Drug: Humalog Drug: Lantus Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Biochaperone Combo
single subcutaneous injection of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
 Drug: Biochaperone Combo
Injection of BioChaperone Combo

Drug: Placebo
Injection of saline 0.9% solution
Active Comparator: Humalog Mix25
single subcutaneous dose of 0.8 U/kg + injection of placebo (0.9% NaCl) to ensure the double dummy
 Drug: Humalog Mix25
Injection of Humalog Mix25

Drug: Placebo
Injection of saline 0.9% solution
Active Comparator: Humalog and Lantus
simultaneous subcutaneous injections of 0.2 U/kg Humalog and 0.6 U/kg Lantus
 Drug: Humalog
Injection of Humalog

Drug: Lantus
Injection of Lantus


Outcome Measures
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Primary Outcome Measures :
  1. Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg) [ Time Frame: from 12h to 30 hours ]
    Area under the glucose infusion rate curve from 12 hours to 30 hours


Secondary Outcome Measures :
  1. AUCGIR 0-last (mg/kg) [ Time Frame: Up to 30 hours ]
    Area under the glucose infusion rate curve from 0 hours until the end of clamp

  2. GIRmax (mg/kg/min) [ Time Frame: Up to 30 hours ]
    Maximum glucose infusion rate

  3. tGIRmax [ Time Frame: Up to 30 hours ]
    Time to maximum glucose infusion rate

  4. AUCLis 0-30h [ Time Frame: Up to 30 hours ]
    Area under the insulin lispro plasma concentration time curve

  5. AUCGla 0-30h [ Time Frame: Up to 30 hours ]
    Area under the insulin glargine plasma concentration time curve

  6. tmax Gla [ Time Frame: Up to 30 hours ]
    Time to maximum insulin glargine plasma concentration

  7. tmax Lis [ Time Frame: Up to 30 hours ]
    Time to maximum insulin lispro plasma concentration

  8. Adverse events [ Time Frame: Up to 9 weeks ]
    Number of adverse events

  9. Hypoglycaemic episodes [ Time Frame: Up to 9 weeks ]
    Number of Hypoglycaemic episodes

  10. Local tolerability [ Time Frame: Up to 9 weeks ]
    Number and intensity of injection site reactions


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514850


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Ulrike Hövelmann, MD Profil Institut Für Stoffwechselfforschung GmbH
More Information
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02514850    
Other Study ID Numbers: BC3-CT018
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs