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A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03981627
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Adocia

Brief Summary:
This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: ADO09 formulation Drug: NovoRapid® Phase 1 Phase 2

Detailed Description:
After a screening visit, eligible subjects will enter a run-in period. Subjects will receive a Continuous Glucose Monitoring (CGM) system for glucose monitoring and control at the beginning of the run-in and for the whole duration of the study. Each eligible subject will then be randomly allocated to a sequence of the 2 treatments, i.e. multiple daily injections of ADO09 and insulin aspart during 2 dosing periods. At Day 1 a mixed meal test (MMT) will be conducted at breakfast and subjects will remain at the clinical site until day 3. At Day 3 subjects will leave the clinical site and continue the treatment with IMP for the next 3 weeks. On Day 23 subjects will come back for a MMT on Day 24.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Single-centre, Double-blind, 2-period Cross-over Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Co-formulation of insulin analog and pramlintide (ADO09)
Subcutaneous injection of ADO09 formulation
Drug: ADO09 formulation
Subcutaneous injection of ADO09 formulation

Active Comparator: NovoRapid®
Subcutaneous injection of insulin aspart
Drug: NovoRapid®
Subcutaneous injection of insulin aspart




Primary Outcome Measures :
  1. ΔAUCPG(0-4h) [ Time Frame: From 0 to 4 hours ]
    Incremental area under the plasma glucose concentration-time curve from 0-4 hours after start of breakfast, assessed by Super GL at day 24.


Secondary Outcome Measures :
  1. Pharmacokinetics of pramlintide [ Time Frame: From 0 to 4 hours ]
    Area under the pramlintide concentration-time curve

  2. Pharmacokinetics of insulins [ Time Frame: From 0 to 4 hours ]
    Area under the insulins concentration-time curve

  3. Plasma glucose control as measured by CGM [ Time Frame: Over 24 hours ]
    Time and percentage of time in Range (TiR) [70-180] mg/dL

  4. Safety and tolerability (Adverse Events recording) [ Time Frame: Up to 24 days ]
    Number of Adverse Events



Information from the National Library of Medicine

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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:

  • Signed and dated informed consent obtained before any trial-related activities.
  • Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months.
  • Treated with insulin ≥ 12 months.
  • Using a multiple dosing insulin therapy (MDI) with basal and bolus insulin.
  • HbA1c <= 9.0%.
  • Fasting negative C-peptide (<= 0.30 nmol/L).

Exclusion Criteria:

  • Known or suspected hypersensitivity to products used in the clinical trial
  • Type 2 diabetes mellitus
  • Previous participation in this trial. Participation is defined as randomized.
  • Receipt of any medicinal product in clinical development within 3 months before randomization in this trial.
  • Known slowing of gastric emptying, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
  • Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
  • Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening.

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): NCT03981627


Contacts
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Contact: Bianca Schmidt +49 2131 4018-0 regulatory@profil.com

Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH Recruiting
Neuss, Germany, 41460
Contact: Grit Andersen, MD    +49 2131 4018-0      
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Grit Andersen, MD Profil Institut für Stoffwechselforschung GmbH

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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT03981627     History of Changes
Other Study ID Numbers: CT038-ADO09
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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 Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs