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A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM

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ClinicalTrials.gov Identifier: NCT02739906
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Adocia

Study Description
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Brief Summary:

This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.

Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.

Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.

The total trial duration for an individual subject will be up to 11 weeks.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: BioChaperone Human Insulin (HinsBet®) Drug: Insulin Lispro (Humalog®) Drug: Regular human insulin (Huminsulin® Normal) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)
Study Start Date : April 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HinsBet® Drug: BioChaperone Human Insulin (HinsBet®)
BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
Active Comparator: Humalog® Drug: Insulin Lispro (Humalog®)
Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
Active Comparator: Huminsulin® Normal Drug: Regular human insulin (Huminsulin® Normal)
Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake


Outcome Measures
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Primary Outcome Measures :
  1. BG1h [ Time Frame: 1 hour ]
    Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal


Secondary Outcome Measures :
  1. ΔBG1h [ Time Frame: 1 hour ]
    Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal

  2. AUCBG,0-1h [ Time Frame: 1 hour ]
    Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

  3. ΔAUCBG,0-1h [ Time Frame: 1 hour ]
    Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

  4. AUCIns,0-1h [ Time Frame: 1 hour ]
    Area under the serum insulin concentration-time curve from 0-1 hour

  5. Adverse Events [ Time Frame: Up to 11 weeks ]
    Number of Adverse Events

  6. Local tolerability (Number of injection site reactions) [ Time Frame: Up to 11 weeks ]
    Number 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:

  • Male or female subject aged 18-64 years (both inclusive).
  • Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
  • Treated with multiple daily insulin injections or CSII >= 12 months.
  • Current total daily insulin treatment < 1.2 (I)U/kg/day.
  • Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
  • BMI 18.5-28.0 kg/m^2 (both inclusive).
  • HbA1c <= 9.0 % by local laboratory analysis
  • Fasting C-peptide <= 0.30 nmol/L.

Exclusion Criteria:

  • Known or suspected hypersensitivity to IMPs or related products.
  • Type 2 diabetes mellitus.
  • 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, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
  • Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the Investigator might change gastrointestinal motility and food absorption.
  • Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective 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): NCT02739906


Locations
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Germany
Profil Mainz GmbH & Co.KG
Mainz, Germany, 44116
Profil GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Oliver Klein, MD Profil GmbH
More Information
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02739906    
Other Study ID Numbers: BC3-CT021
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs