NCT03180710

Brief Summary

This is a bicentric, double-blinded, randomised, four-period crossover phase 1 trial, using automated 30-hour euglycemic clamp in subjects with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2017

Typical duration for phase_1 type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

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

June 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

June 6, 2017

Last Update Submit

January 9, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • AUC last_total

    Area under the plasma insulin concentration-time curve from t=0 to the last measured total insulin plasma concentration above LLOQ. The total insulin concentration is the sum of lispro and basal concentrations.

    From 0 to 30 hours

  • Cmax_total

    Maximum observed plasma insulin total concentration

    From 0 to 30 hours

Secondary Outcomes (6)

  • AUCGIR 0-last (mg/kg)

    From 0 to 30 hours

  • GIRmax (mg/kg/min)

    From 0 to 30 hours

  • tGIRmax

    From 0 to 30 hours

  • Adverse Events

    Up to 102 days (maximum duration of subject's participation)

  • Local tolerability: number of injection site reaction

    Up to 102 days (maximum duration of subject's participation)

  • +1 more secondary outcomes

Study Arms (4)

BioChaperone® Combo 75/25 at 0.6 U/kg

EXPERIMENTAL

Single subcutaneous injection of 0.6 U/kg

Drug: BioChaperone® Combo 75/25 at 0.6 U/kg

BioChaperone® Combo 75/25 at 0.8 U/kg

EXPERIMENTAL

Single subcutaneous dose of 0.8 U/kg

Drug: BioChaperone® Combo 75/25 at 0.8 U/kg

BioChaperone® Combo 75/25 at 1.0 U/kg

EXPERIMENTAL

Single subcutaneous dose of 1.0 U/kg

Drug: BioChaperone® Combo 75/25 at 1.0 U/kg

Humalog® Mix25 at 0.8 U/kg

ACTIVE COMPARATOR

Single subcutaneous dose of 0.8 U/kg

Drug: Humalog® Mix25 at 0.8 U/kg

Interventions

BioChaperone® Combo 75/25 at 0.6 U/kgDRUG

Injection of BioChaperone® Combo 75/25 at 0.6 U/kg

BioChaperone® Combo 75/25 at 0.6 U/kg
BioChaperone® Combo 75/25 at 0.8 U/kgDRUG

Injection of BioChaperone® Combo 75/25 at 0.8 U/kg

BioChaperone® Combo 75/25 at 0.8 U/kg
BioChaperone® Combo 75/25 at 1.0 U/kgDRUG

Injection of BioChaperone® Combo 75/25 at 1.0 U/kg

BioChaperone® Combo 75/25 at 1.0 U/kg
Humalog® Mix25 at 0.8 U/kgDRUG

Injection of Humalog® Mix25 at 0.8 U/kg

Humalog® Mix25 at 0.8 U/kg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subject aged 18-70 years (both inclusive)
  • Type 2 diabetes mellitus (as diagnosed clinically) for ≥ 12 months
  • HbA1c level between 6.5% and 9.0 % (both inclusive)
  • Body mass index between 20.0 and 40.0 kg/m2 (both inclusive)
  • Body weight \<= 125.0 kg at the screening visit
  • Insulin-treated subjects. Total insulin dose of \<= 1.2 (I)U/kg/day

You may not qualify if:

  • Type 1 diabetes mellitus
  • Known or suspected hypersensitivity to IMP(s) or related products
  • Previous participation in this trial. Participation is defined as randomised.
  • Receipt of any medicinal product in clinical development within 60 days before randomisation in this trial.
  • Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator considering the underlying disease.
  • Women of child bearing potential not willing to use contraceptive methods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Profil Mainz GmbH & Co. KG

Mainz, Germany

Location

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Oliver Klein, 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

June 6, 2017

First Posted

June 8, 2017

Study Start

June 6, 2017

Primary Completion

August 28, 2017

Study Completion

December 21, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)