A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BC Pram Ins
Symlin® and Humulin®
Humalog®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility 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
Sites / Locations
- Profil Institut für Stoffwechselforschung GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
BC Pram Ins
Symlin® and Humulin®
Humalog®
Arm Description
Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy
Simultaneous subcutaneous injections avec pramlintide and human insulin
Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy
Outcomes
Primary Outcome Measures
CmaxPram
Maximum pramlintide concentration
AUCPram_0-8h
Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration
Secondary Outcome Measures
Pharmacokinetics of pramlintide
Area Under the pramlintide concentration-time Curve
Pharmacokinetics of insulins
Area Under the insulin concentration-time Curve
Glucose pharmacodynamics
Area Under the blood glucose concentration-time Curve
Safety and tolerability (Adverse Events recording)
Number of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03512236
Brief Title
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
Official Title
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
February 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adocia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BC Pram Ins
Arm Type
Experimental
Arm Description
Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy
Arm Title
Symlin® and Humulin®
Arm Type
Active Comparator
Arm Description
Simultaneous subcutaneous injections avec pramlintide and human insulin
Arm Title
Humalog®
Arm Type
Active Comparator
Arm Description
Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy
Intervention Type
Drug
Intervention Name(s)
BC Pram Ins
Intervention Description
Injection of BC Pram Ins
Intervention Type
Drug
Intervention Name(s)
Symlin® and Humulin®
Intervention Description
Injection of pramlintide and human insulin
Intervention Type
Drug
Intervention Name(s)
Humalog®
Intervention Description
Injection of lispro
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection of 0.9% NaCl
Primary Outcome Measure Information:
Title
CmaxPram
Description
Maximum pramlintide concentration
Time Frame
From 0 to 8 hours
Title
AUCPram_0-8h
Description
Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration
Time Frame
From 0 to 8 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetics of pramlintide
Description
Area Under the pramlintide concentration-time Curve
Time Frame
From 0 to 8 hours
Title
Pharmacokinetics of insulins
Description
Area Under the insulin concentration-time Curve
Time Frame
From 0 to 8 hours
Title
Glucose pharmacodynamics
Description
Area Under the blood glucose concentration-time Curve
Time Frame
From 0 to 8 hours
Title
Safety and tolerability (Adverse Events recording)
Description
Number of adverse events
Time Frame
From 0 to 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grit Andersen, MD
Organizational Affiliation
Profil Institut für Stoffwechselforschung GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil Institut für Stoffwechselforschung GmbH
City
Neuss
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
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