NCT03512236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

April 19, 2018

Last Update Submit

February 20, 2019

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • CmaxPram

    Maximum pramlintide concentration

    From 0 to 8 hours

  • AUCPram_0-8h

    Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration

    From 0 to 8 hours

Secondary Outcomes (4)

  • Pharmacokinetics of pramlintide

    From 0 to 8 hours

  • Pharmacokinetics of insulins

    From 0 to 8 hours

  • Glucose pharmacodynamics

    From 0 to 8 hours

  • Safety and tolerability (Adverse Events recording)

    From 0 to 8 hours

Study Arms (3)

BC Pram Ins

EXPERIMENTAL

Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy

Drug: BC Pram InsDrug: Placebo

Symlin® and Humulin®

ACTIVE COMPARATOR

Simultaneous subcutaneous injections avec pramlintide and human insulin

Drug: Symlin® and Humulin®

Humalog®

ACTIVE COMPARATOR

Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy

Drug: Humalog®Drug: Placebo

Interventions

BC Pram InsDRUG

Injection of BC Pram Ins

BC Pram Ins
Symlin® and Humulin®DRUG

Injection of pramlintide and human insulin

Symlin® and Humulin®
Humalog®DRUG

Injection of lispro

Humalog®
PlaceboDRUG

Injection of 0.9% NaCl

BC Pram InsHumalog®

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

pramlintideInsulin, Regular, HumanInsulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

InsulinProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

Study Officials

  • Grit Andersen, MD

    Profil Institut für Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2018

First Posted

April 30, 2018

Study Start

April 25, 2018

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

February 21, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)