A Study to Investigate Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Subjects with Type 1 Diabetes Mellitus (T1DM)

A Randomized, Open-Label, 4-Period Cross-Over Study to Investigate the Inter- and Intra-subject Variability 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

EUCTR2015-003737-95-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 (both inclusive) with T1DM • HbA1c = 9.0% inclusive • Subjects with T1DM taking 2 or more injections of insulin daily 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 drug absorption from the lung, in particular subjects with decreased lung function, any active pulmonary disease or taking 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 • Recurrent severe hypoglycemia • Proliferative retinopathy or maculopathy or severe autonomic neuropathy • Current treatment with medications that may interfere with glucose metabolism • Clinical significant abnormal findings during physical examination, laboratory and ECG results at screening

Design outcomes

Primary

Measure	Time frame
Main Objective: Assessment of the inter- and intra subject variability (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 pharmacokinetic (PK) and pharmacodynamic (PD) responses of INH • Assessment of the relative efficiency of INH compared to subcutaneous (s.c.) insulin lispro • Safety and tolerability of INH ; Primary end point(s): Primary Pharmacokinetic Endpoints: 1. AUCINS, 0-10h: Area under insulin (INS) and insulin lispro curve 2. CMAX INS: Maximum observed insulin or insulin lispro concentration Primary Pharmacodynamic Endpoints: 1. AUCGIR,0-10h : Area under the glucose infusion rate-time curve 2. GIRMAX: Maximum glucose infusion rate Safety endpoints: • Adverse Events (including adverse device effects and hypoglycemic episodes) • Clinical laboratory measures • Physical examinations • Vital signs • Electrocardiogram (ECG) • Spirometry • 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 hours 2. maximum observed GIR Safety endpoints: ongoing	—

Measure

Time frame

Main Objective: Assessment of the inter- and intra subject variability (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 pharmacokinetic (PK) and pharmacodynamic (PD) responses of INH • Assessment of the relative efficiency of INH compared to subcutaneous (s.c.) insulin lispro • Safety and tolerability of INH ; Primary end point(s): Primary Pharmacokinetic Endpoints: 1. AUCINS, 0-10h: Area under insulin (INS) and insulin lispro curve 2. CMAX INS: Maximum observed insulin or insulin lispro concentration Primary Pharmacodynamic Endpoints: 1. AUCGIR,0-10h : Area under the glucose infusion rate-time curve 2. GIRMAX: Maximum glucose infusion rate Safety endpoints: • Adverse Events (including adverse device effects and hypoglycemic episodes) • Clinical laboratory measures • Physical examinations • Vital signs • Electrocardiogram (ECG) • Spirometry • 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 hours 2. maximum observed GIR Safety endpoints: ongoing

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary Pharmacokinetic Endpoints: • AUCINS 0-1h: Area under insulin (INS) and insulin lispro curve from t= 0 to 1hour • AUCINS 0-2h: Area under insulin (INS) and insulin lispro curve from t= 0 to 2hours • AUCINS 0-8h: Area under insulin (INS) and insulin lispro curve from t= 0 to 8hours • tMAX INS: Time to maximum insulin concentration • FREL: Relative efficiency = dose corrected ratio of AUCINS, 0-10h for INH and s.c. insulin lispro • Onset of appearance: time from trial product administration until first time serum insulin concentration > LLOQ (in case of different LLOQ values further restrictions will be defined in section 13) • MRTINS: mean residence time of insulin • t50%-INS(early), time to half-maximum before Cmax • t50%-INS(late), time to half-maximum after Cmax Secondary Pharmacodynamic Endpoints: • AUCGIR 0-1h : Area under the glucose infusion rate-time curve from t=0 to 1hour • AUCGIR 0-2h : Area under the glucose infusion rate-time curve from t=0 to 2hours • AUCGIR 0-8h : Area under the glucose infusion rate-time curve from t=0 to 8hours • tGIRMAX: Time to maximum glucose infusion rate • GREL: Relative biopotency = dose corrected ratio of AUCGIR,0-10h for INH and s.c. insulin lispro • Duration of action • t50%-GIR(early), time to half-maximum glucose infusion rate before GIRmax • t50%-GIR(late), time to half-maximum glucose infusion rate after GIRmax ;Timepoint(s) of evaluation of this end point: as detailed in section E.5.2	—

Measure

Time frame

Secondary end point(s): Secondary Pharmacokinetic Endpoints: • AUCINS 0-1h: Area under insulin (INS) and insulin lispro curve from t= 0 to 1hour • AUCINS 0-2h: Area under insulin (INS) and insulin lispro curve from t= 0 to 2hours • AUCINS 0-8h: Area under insulin (INS) and insulin lispro curve from t= 0 to 8hours • tMAX INS: Time to maximum insulin concentration • FREL: Relative efficiency = dose corrected ratio of AUCINS, 0-10h for INH and s.c. insulin lispro • Onset of appearance: time from trial product administration until first time serum insulin concentration > LLOQ (in case of different LLOQ values further restrictions will be defined in section 13) • MRTINS: mean residence time of insulin • t50%-INS(early), time to half-maximum before Cmax • t50%-INS(late), time to half-maximum after Cmax Secondary Pharmacodynamic Endpoints: • AUCGIR 0-1h : Area under the glucose infusion rate-time curve from t=0 to 1hour • AUCGIR 0-2h : Area under the glucose infusion rate-time curve from t=0 to 2hours • AUCGIR 0-8h : Area under the glucose infusion rate-time curve from t=0 to 8hours • tGIRMAX: Time to maximum glucose infusion rate • GREL: Relative biopotency = dose corrected ratio of AUCGIR,0-10h for INH and s.c. insulin lispro • Duration of action • t50%-GIR(early), time to half-maximum glucose infusion rate before GIRmax • t50%-GIR(late), time to half-maximum glucose infusion rate after GIRmax ;Timepoint(s) of evaluation of this end point: as detailed in section E.5.2

—

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