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A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03512236
Recruitment Status : Completed
First Posted : April 30, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Adocia

Brief Summary:
This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: BC Pram Ins Drug: Symlin® and Humulin® Drug: Humalog® Drug: Placebo Phase 1

Detailed Description:

This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.

Each subject will be randomly allocated to a sequence of three treatments:(i) simultaneous administrations of BioChaperone® pramlintide human insulin (BC Pram Ins) and placebo, (ii) simultaneous injections of pramlintide (Symlin®) and human insulin (Humulin®) and (iii) simultaneous injections of insulin lispro (Humalog®) and placebo.

Subjects will come in a fasted state to the clinical trial centre in the morning, meal test procedures will be performed and subjects will stay at the clinical trial centre until the post-dose follow-up period has been terminated.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : April 25, 2018
Actual Primary Completion Date : February 14, 2019
Actual Study Completion Date : February 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: BC Pram Ins
Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy
Drug: BC Pram Ins
Injection of BC Pram Ins

Drug: Placebo
Injection of 0.9% NaCl

Active Comparator: Symlin® and Humulin®
Simultaneous subcutaneous injections avec pramlintide and human insulin
Drug: Symlin® and Humulin®
Injection of pramlintide and human insulin

Active Comparator: Humalog®
Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy
Drug: Humalog®
Injection of lispro

Drug: Placebo
Injection of 0.9% NaCl




Primary Outcome Measures :
  1. CmaxPram [ Time Frame: From 0 to 8 hours ]
    Maximum pramlintide concentration

  2. AUCPram_0-8h [ Time Frame: From 0 to 8 hours ]
    Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration


Secondary Outcome Measures :
  1. Pharmacokinetics of pramlintide [ Time Frame: From 0 to 8 hours ]
    Area Under the pramlintide concentration-time Curve

  2. Pharmacokinetics of insulins [ Time Frame: From 0 to 8 hours ]
    Area Under the insulin concentration-time Curve

  3. Glucose pharmacodynamics [ Time Frame: From 0 to 8 hours ]
    Area Under the blood glucose concentration-time Curve

  4. Safety and tolerability (Adverse Events recording) [ Time Frame: From 0 to 8 hours ]
    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:

  • Male or female subjects aged 18-64 years (both inclusive)
  • Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months
  • Treated with multiple daily insulin injections ≥ 12 months
  • Treated with an evening dose of once-daily insulin glargine U100 at screening
  • Fasting C-peptide ≤ 0.30 nmol/L

Exclusion Criteria:

  • Known or suspected hypersensitivity to IMPs, paracetamol (acetaminophen) or related products
  • Type 2 diabetes mellitus
  • Clinically significant abnormal haematology, biochemistry, 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, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption
  • 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): NCT03512236


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
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: NCT03512236     History of Changes
Other Study ID Numbers: CT031-ADO09
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Lispro
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action