A Study to Investigate the Dose Response of Dance 501 in Subjects with Type 1 Diabetes Mellitus (T1DM)

A Randomized, Open-Label, 6-Period Cross-Over Study to Investigate the Dose Response of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects with Type 1 Diabetes Mellitus (T1DM)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003672-76-DE

Enrollment

Registered

2018-09-25

Start date

2018-11-27

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Dance 501 Human Insulin Inhalation Solution Pharmaceutical Form: Nebuliser solution INN or Proposed INN: INSULIN HUMAN CAS Number: 11061-6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male and female subjects 18 to 55 years of age, inclusive • Diagnosed with T1DM • Body mass index (BMI) = 18.5 and = 30 kg/m2 • HbA1c = 9.0 % inclusive • Fasting C-peptide = 0.30 nmol/L • Treated with 2 or more daily injections of insulin or continuous s.c. insulin infusion for at least 6 months prior to screening • Current total daily insulin treatment =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Any condition possibly affecting pulmonary drug absorption, in particular significant abnormalities in lung function testing, any active pulmonary disease, or treatment with bronchodilators • Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer • Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), or signs of acute illness, as judged by the Investigator • Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis • Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy • Recurrent severe hypoglycemia • Current treatment with drugs which may interfere with glucose metabolism

Design outcomes

Primary

Measure	Time frame
Main Objective: • Assessment of the linearity of the dose-response and dose-exposure relationship (based on AUCINS,0-10h, CMAX,INS, AUCGIR,0-10h, and GIRMAX ) of Dance 501 Human Insulin Inhalation Solution (INH) administered with the Dance 501 Inhaler; Secondary Objective: • Assessment of the PK and PD responses at three doses of Dance 501 Human Insulin Inhalation Solution administered with the Dance 501 Inhaler • Assessment of the relative efficiency of Dance 501 Human Insulin Inhalation Solution administered with the Dance 501 Inhaler compared to s.c. insulin lispro • Safety and tolerability of Dance 501 Human Insulin Inhalation Solution administered with the Dance 501 Inhaler ; Primary end point(s): Primary Pharmacokinetic Endpoints: • AUCINS,0-10h, area under the human insulin and insulin lispro concentration-time curves from 0 to 10 hours (if AUCINS,0-10h cannot be reached, pre-defined restrictions will be followed (see section 13) • CMAX,INS, maximum observed concentration of human insulin and of insulin lispro Primary Pharmacodynamic Endpoints: 1. AUCGIR,0-10h, area under GIR-time curve from t=0 to 10 hours 2. GIRMAX, maximum observed GIR Safety endpoints: • Adverse events (including adverse device effects and hypoglycemic episodes) • Clinical laboratory measures • Physical examinations • Vital signs • Spirometry • Electrocardiogram (ECG) • Insulin antibodies ; Timepoint(s) of evaluation of this end point: Primary Pharmacokinetic Endpoints: 1. from t=0 to 10 hours 2. maximum observed concentration Primary Pharmacodynamic Endpoints: 1. from t=0 to 10 hour	—

Measure

Time frame

Main Objective: • Assessment of the linearity of the dose-response and dose-exposure relationship (based on AUCINS,0-10h, CMAX,INS, AUCGIR,0-10h, and GIRMAX ) of Dance 501 Human Insulin Inhalation Solution (INH) administered with the Dance 501 Inhaler; Secondary Objective: • Assessment of the PK and PD responses at three doses of Dance 501 Human Insulin Inhalation Solution administered with the Dance 501 Inhaler • Assessment of the relative efficiency of Dance 501 Human Insulin Inhalation Solution administered with the Dance 501 Inhaler compared to s.c. insulin lispro • Safety and tolerability of Dance 501 Human Insulin Inhalation Solution administered with the Dance 501 Inhaler ; Primary end point(s): Primary Pharmacokinetic Endpoints: • AUCINS,0-10h, area under the human insulin and insulin lispro concentration-time curves from 0 to 10 hours (if AUCINS,0-10h cannot be reached, pre-defined restrictions will be followed (see section 13) • CMAX,INS, maximum observed concentration of human insulin and of insulin lispro Primary Pharmacodynamic Endpoints: 1. AUCGIR,0-10h, area under GIR-time curve from t=0 to 10 hours 2. GIRMAX, maximum observed GIR Safety endpoints: • Adverse events (including adverse device effects and hypoglycemic episodes) • Clinical laboratory measures • Physical examinations • Vital signs • Spirometry • Electrocardiogram (ECG) • Insulin antibodies ; Timepoint(s) of evaluation of this end point: Primary Pharmacokinetic Endpoints: 1. from t=0 to 10 hours 2. maximum observed concentration Primary Pharmacodynamic Endpoints: 1. from t=0 to 10 hour

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Pharmacokinetic Endpoints: • Area under the insulin (INS) curves (AUCINS) for different time-intervals: AUCINS,0-1h, AUCINS,0-2h, AUCINS,0-8h • Time to maximum insulin concentrations (tMAX,INS) • Relative efficiency (FREL, dose corrected ratio of AUCINS,ALL for INH and s.c. insulin) • Onset of appearance (time from trial product administration until the first time serum insulin concentration > LLOQ) (in case of different LLOQ values pre-defined restrictions will be followed (see section 13) • Mean residence time of insulin (MRTINS) Secondary Pharmacodynamic Endpoints: • Area under the glucose infusion rate (GIR) curves (AUCGIR) for different time-intervals: AUCGIR,0-1h, AUCGIR,0-2h, AUCGIR,0-8h • Time to maximum glucose infusion rate (tGIR,MAX) • Relative biopotency (GREL, dose corrected ratio of AUCGIR 0-10h for INH and s.c. Insulin) ;Timepoint(s) of evaluation of this end point: as given in section E.5.2	—

Measure

Time frame

Secondary end point(s): Secondary Pharmacokinetic Endpoints: • Area under the insulin (INS) curves (AUCINS) for different time-intervals: AUCINS,0-1h, AUCINS,0-2h, AUCINS,0-8h • Time to maximum insulin concentrations (tMAX,INS) • Relative efficiency (FREL, dose corrected ratio of AUCINS,ALL for INH and s.c. insulin) • Onset of appearance (time from trial product administration until the first time serum insulin concentration > LLOQ) (in case of different LLOQ values pre-defined restrictions will be followed (see section 13) • Mean residence time of insulin (MRTINS) Secondary Pharmacodynamic Endpoints: • Area under the glucose infusion rate (GIR) curves (AUCGIR) for different time-intervals: AUCGIR,0-1h, AUCGIR,0-2h, AUCGIR,0-8h • Time to maximum glucose infusion rate (tGIR,MAX) • Relative biopotency (GREL, dose corrected ratio of AUCGIR 0-10h for INH and s.c. Insulin) ;Timepoint(s) of evaluation of this end point: as given in section E.5.2

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Countries

Germany

Contacts

Public ContactDr. Lisa Porter

Dance Biopharm, Inc

lporter@dancebiopharm.com+18583446515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026