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A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916640
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Adocia

Brief Summary:
This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: ADO09 formulation Drug: Placebo Drug: Symlin® Drug: Humulin® Drug: Humalog® Phase 1

Detailed Description:
In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.

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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 a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
Actual Study Start Date : January 4, 2019
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 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 + injection of placebo (0.9% NaCl) to ensure double dummy.
Drug: ADO09 formulation
Subcutaneous injection of ADO09 formulation

Drug: Placebo
Subcutaneous injection of 0.9% NaCl

Active Comparator: Humulin® + Symlin®
Simultaneous, separate subcutaneous injections of human insulin and pramlintide.
Drug: Symlin®
Subcutaneous injection of pramlintide

Drug: Humulin®
Subcutaneous injection of human insulin

Active Comparator: Humalog®
Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy.
Drug: Placebo
Subcutaneous injection of 0.9% NaCl

Drug: Humalog®
Subcutaneous injection of insulin lispro




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

  3. CmaxIns [ Time Frame: From 0 to 8 hours ]
    Maximum insulin analog concentration

  4. AUCIns 0-8h [ Time Frame: From 0 to 8 hours ]
    Area under the insulin analog 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 insulins 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:

  • Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months
  • Treated with multiple daily injection ≥ 12 months
  • Treated with insulin glargine U100 or U300 or insulin detemir at screening
  • Fasting C-peptide ≤ 0.30 nmol/L
  • BMI: 18.5-28.0 kg/m² (both inclusive)

Exclusion Criteria:

  • Known or suspected hypersensitivity to IMPs, paracetamol or related products
  • Type 2 Diabetes Mellitus
  • Clinically significant abnormal haematology, biochemistry or urinalysis screening test, 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): NCT03916640


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: Grit Andersen, MD Profil Institut für Stoffwechselforschung GmbH
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT03916640    
Other Study ID Numbers: CT034-ADO09
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 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 Lispro
Hypoglycemic Agents
Physiological Effects of Drugs