Trials Sponsors Conditions Drugs Pricing

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.

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

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

Sponsors & Collaborators

Dance Biopharm Inc.
Industrylead

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 Compounds

Study Officials

Tim Heise, MD
Profil Institut für Stoffwechselforschung GmbH
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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 2013

Date type not reported

This date has not been verified as actual or estimated.

Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Study Arms (5)

INH 69 U (low)

INH 69 U (high)

INH 139 U

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

INH 208 U

LIS 18 U

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (1)

Study Arms (5)

INH 69 U (low)

INH 69 U (high)

INH 139 U

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

INH 208 U

LIS 18 U

You may not qualify if:

Data Sharing

Source record