NCT04100473

Brief Summary

This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2018

Typical duration for phase_2 type-2-diabetes-mellitus

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

Study Start

First participant enrolled

April 23, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

February 25, 2019

Last Update Submit

September 20, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

Inhaled Insulin

Outcome Measures

Primary Outcomes (4)

  • Primary Pharmacokinetic Endpoint - PK 1

    Area under the human insulin and insulin lispro concentrations time curves

    0 - 10 hours

  • Primary Pharmacokinetic Endpoint - PK 2

    Maximum observed concentration of human insulin and insulin lispro

    0 - 10 hours

  • Primary Pharmacodynamic Endpoint - PD 1

    Area under the glucose infusion rate time curve

    0 - 10 hours

  • Primary Pharmacodynamic Endpoint - PD 2

    Maximum observed glucose infusion rate

    0 - 10 hours

Secondary Outcomes (8)

  • Secondary Pharmacokinetic Endpoint - PK 1

    0 - 1 hour, 0 - 2 hours, 0 - 8 hours

  • Secondary Pharmacokinetic Endpoint - PK 2

    0 - 10 hours

  • Secondary Pharmacokinetic Endpoint - PK 3

    0 - 10 hours

  • Secondary Pharmacokinetic Endpoint - PK 4

    0 - 10 hours

  • Secondary Pharmacokinetic Endpoint - PK 5

    0 - 10 hours

  • +3 more secondary outcomes

Study Arms (2)

Dance 501

EXPERIMENTAL

Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered using the Dance 501 Inhaler.

Drug: Inhaled Human Insulin

Insulin Lispro

ACTIVE COMPARATOR

Insulin Lispro (Humalog®) will be administered by subcutaneous injection.

Drug: Insulin Lispro (Humalog U-100)

Interventions

Inhaled Human InsulinDRUG

Dance 501 administered using the Dance 501 Inhaler

Also known as: Dance 501
Dance 501
Insulin Lispro (Humalog U-100)DRUG

Lispro

Also known as: Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
Insulin Lispro

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed with T2DM.
  • BMI between 25.0 and 40.0 kg/m2.
  • Treated with metformin and/or at least 1 daily injection of insulin for at least 6 months.
  • Non-smoker for at least 5 years.
  • Forced vital capacity and forced expiratory volume in one second is at least 75% normal.

You may not qualify if:

  • Any condition affecting pulmonary drug absorption.
  • History or presence of cancer except basal cell skin cancer or squamous cell skin cancer.
  • Serious systemic infectious disease during four weeks prior to dosing.
  • Clinically significant abnormal lab values.
  • Proliferative retinopathy and/or severe neuropathy.
  • Recurrent severe hypoglycemia.
  • Current treatment with oral anti-diabetic drugs except metformin, glucagon-like peptide receptor agonists.
  • Current treatment with MAO inhibitors.
  • Unstable Thyroid hormones for at least 3 months.
  • Insufficient glycemic control with significant fluctuations of blood glucose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Mainz

Mainz, Malakoff-Passage, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Oliver Klein

    Profil Institut fur Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, Open-Label, Cross-Over design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

September 24, 2019

Study Start

April 23, 2018

Primary Completion

August 11, 2018

Study Completion

August 1, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)