Diabetes mellitus type 2 MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Insulin human for inhalation
Product Code: Dance 01
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Concentration unit: IU/ml i
Sponsors
Dance Biopharm, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Type 2 diabetes mellitus for more than 12 months •Treated with one or multiple daily insulin injections for more than 3 months •Concomitant treatment with metformin in stable doses will be permitted (and continued throughout the trial). •Body mass index (BMI) between 25.0-40.0 kg/m² (both inclusive) •Fasting C-peptide = 1.0 nmol/l Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: •Clinically significant abnormal haematology, biochemistry, lipids, urinalysis or coagulation screening tests, as judged by the Investigator considering the underlying disease •Cardiac disease •Hepatic insufficiency •Impaired renal function •Current treatment with systemic corticosteroids, MAO inhibitors, prostaglandin blockers, systemic non-selective beta-blockers, growth hormone, and other drugs, which may interfere with glucose metabolism. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months. •Uncontrolled treated/untreated hypertension •Any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators. •Any active or chronic pulmonary disease as documented by history, physical examination or pulmonary function tests at screening. •Current smoker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Assessment of the linearity of the dose response curves (based on AUCINS,0-8, CMAX,INS, AUCGIR,0-12h and GIRMAX) of inhaled insulin •Comparison of the inter- and intra-subject variability (based on AUCINS,0-8, CMAX,INS, AUCGIR,0-12h and GIRMAX) of inhaled insulin with subcutaneous insulin (Humalog®, insulin lispro) administration ;Secondary Objective: •Assessment of the pharmacokinetic and pharmacodynamic responses at three dose levels of inhaled insulin •Comparison of the pharmacokinetic and pharmacodynamic responses after 1 actuation of 9 IU high-concentration (900 IU/mL) inhalation formulation versus 3 actuations of the 3 IU low-concentration (300 IU/mL) inhalation formulation •Assessment of the relative efficiency of inhaled insulin •Safety and tolerability of the inhaled insulin ;Primary end point(s): Primary pharmacokinetic endpoints 1. AUCINS,0-8 2. CMAX,INS 3. Dose-exposure relationship 4. Inter- and intra-subject variability Primary pharmacodynamic endpoints 1. AUCGIR,0-12h 2. GIRMAX 3. Dose-response relationship 4. Inter- and intra-subject variability ;Timepoint(s) of evaluation of this end point: Primary pharmacokinetic endpoints 1. from 0 hours to infinity 2. maximum observed insulin human / insulin lispro concentration 3. based on AUCINS 0 8 and CMAX,INS 4. based on AUCINS,0-8, CMAX,INS Primary pharmacodynamic endpoints 1. from 0 to 12 hours 2. maximum observed GIR 3. based on AUCGIR 0 12h and GIRMAX 4. based on AUCGIR,0-12h and GIRMAX | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary pharmacokinetic endpoints 1. AUCINS,0-1h 2. AUCINS,0-2h 3. AUCINS,0-4h 4. AUCINS,0-12h 5. TMAX,INS 6. FREL 7. Onset of appearance 8. t1/2-INS 9. MRTINS Secondary pharmacodynamic endpoints 1. AUCGIR,0-1h 2. AUCGIR,0-2h 3. AUCGIR,0-4h 4. TGIR,MAX 5. t50%-GIR 6. GREL 7. Duration of action;Timepoint(s) of evaluation of this end point: Secondary pharmacokinetic endpoints 1. from 0 to 1 hour 2. from 0 to 2 hours 3. from 0 to 4 hours 4. 0 to 12 hours 5. time to maximum observed insulin human / insulin lispro concentration 6. from 0 to infinity 7. time from trial product administration until the first time serum insulin concentration > LLOQ 8. terminal half-life of insulin 9. mean residence time of insulin Secondary pharmacodynamic endpoints 1. from 0 to 1 hour 2. from 0 to 2 hours 3. from 0 to 4 hours 4. time to maximum GIR 5. time to half-maximum glucose infusion rate before and after GIRmax (early and late) 6. relative biopotency of (inhaled) insulin human compared to (sc injected) insulin 7. ongoing | — |
Countries
Germany
Contacts
Public ContactMelinda Whiteside
Dance Biopharm, Inc.
Outcome results
None listed