NCT02716610

Brief Summary

Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin

Trial Health

100
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 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

March 9, 2016

Last Update Submit

March 17, 2016

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

  • Area under the curve for insulin from 0-8 hours (AUCins0-8h)

    Assessment of the linearity of the dose-response curves

    0 to 8 hours following each dose

  • Maximum concentration of insulin (CMaxIns)

    Assessment of the linearity of the dose-response curves

    up to 12 hours following each dose

  • Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h)

    Assessment of the linearity of the dose-response curves

    0 to 8 hours following each dose

  • Maximum glucose infusion rate (GIRmax)

    Assessment of the linearity of the dose-response curves

    up to 12 hours following each dose

Secondary Outcomes (1)

  • Bioavailability

    0 to 8 hours following each dose

Study Arms (5)

INH 69 U (low)

EXPERIMENTAL

single 69 U dose administration of Dance inhaled human insulin using a low-concentration formulation (300 U/mL)

Drug: INH 69 U (low)

INH 69 U (high)

EXPERIMENTAL

single 69 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL)

Drug: INH 69 U (high)

INH 139 U

EXPERIMENTAL

single 139 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL) This arm was repeated in order to evaluate intra-subject variability.

Drug: INH 139 U

INH 208 U

EXPERIMENTAL

single 208 U dose administration of Dance inhaled human insulin using a high-concentration formulation (900 U/mL)

Drug: INH 208 U

LIS 18 U

ACTIVE COMPARATOR

single 18 U dose administration of subcutaneous insulin lispro using a 100 U/mL formulation This arm was repeated in order to evaluate intra-subject variability.

Drug: LIS 18 U

Interventions

INH 69 U (low)DRUG

inhaled human insulin

Also known as: Dance-501
INH 69 U (low)
INH 69 U (high)DRUG

inhaled human insulin

Also known as: Dance-501
INH 69 U (high)
INH 139 UDRUG

inhaled human insulin

Also known as: Dance-501
INH 139 U
INH 208 UDRUG

inhaled human insulin

Also known as: Dance-501
INH 208 U
LIS 18 UDRUG

subcutaneous insulin lispro

Also known as: subcutaneous insulin lispro
LIS 18 U

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 U/kg/day.
  • Body mass index 25-40 kg/m2
  • Hemoglobin A1c 6.5-9.5%
  • Forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values.
  • Fasting c-peptide less than 1 nmol/L

You may not qualify if:

  • Any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke.
  • Active or chronic pulmonary disease.
  • Any major disorder other than type 2 diabetes.
  • Decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months.
  • Proliferative retinopathy or maculopathy or severe neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Tim Heise, MD

    Profil Institut für Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 23, 2016

Study Start

October 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

March 23, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share