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

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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

Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE January 4, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • CmaxPram [ Time Frame: From 0 to 8 hours ]
    Maximum pramlintide concentration
  • AUCPram 0-8h [ Time Frame: From 0 to 8 hours ]
    Area under the pramlintide concentration-time curve from 0-8 hours after IMP administration
  • CmaxIns [ Time Frame: From 0 to 8 hours ]
    Maximum insulin analog concentration
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • Pharmacokinetics of pramlintide [ Time Frame: From 0 to 8 hours ]
    Area under the pramlintide concentration-time curve
  • Pharmacokinetics of insulins [ Time Frame: From 0 to 8 hours ]
    Area under the insulins concentration-time curve
  • Glucose pharmacodynamics [ Time Frame: From 0 to 8 hours ]
    Area under the blood glucose concentration-time curve
  • Safety and tolerability (Adverse Events recording) [ Time Frame: From 0 to 8 hours ]
    Number of Adverse Events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
Official Title  ICMJE 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
Brief Summary This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: ADO09 formulation
    Subcutaneous injection of ADO09 formulation
  • Drug: Placebo
    Subcutaneous injection of 0.9% NaCl
  • Drug: Symlin®
    Subcutaneous injection of pramlintide
  • Drug: Humulin®
    Subcutaneous injection of human insulin
  • Drug: Humalog®
    Subcutaneous injection of insulin lispro
Study Arms  ICMJE
  • Experimental: Co-formulation of insulin analog and pramlintide (ADO09)
    Subcutaneous injection of ADO09 formulation + injection of placebo (0.9% NaCl) to ensure double dummy.
    Interventions:
    • Drug: ADO09 formulation
    • Drug: Placebo
  • Active Comparator: Humulin® + Symlin®
    Simultaneous, separate subcutaneous injections of human insulin and pramlintide.
    Interventions:
    • Drug: Symlin®
    • Drug: Humulin®
  • Active Comparator: Humalog®
    Subcutaneous injection of insulin lispro + injection of placebo (0.9% NaCl) to ensure double dummy.
    Interventions:
    • Drug: Placebo
    • Drug: Humalog®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2019)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2019
Actual Primary Completion Date March 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03916640
Other Study ID Numbers  ICMJE CT034-ADO09
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adocia
Study Sponsor  ICMJE Adocia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Grit Andersen, MD Profil Institut für Stoffwechselforschung GmbH
PRS Account Adocia
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP