Back to results

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

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT03512236

First Posted

April 19, 2018

Last Updated

February 20, 2019

Sponsor

Adocia

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

We'll reach out to this number within 24 hrs