Type 1 diabetes mellitus MedDRA version: 15.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Insulin human for inhalation
Product Code: Dance 01
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: INSULIN HUMAN
CAS Number: 11061-68-0
Concentration unit: U/ml unit(s)/m
Sponsors
Dance Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2.Male or female subjects aged 18–64 years (both inclusive). 3.Type 1 diabetes mellitus (as diagnosed clinically) = 12 months. 4.Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) = 12 months. 5.Current total daily insulin treatment =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity to trial product(s) or related products. 2.Previous participation in this trial. Participation is defined as randomised. 3.Subjects with any condition possibly affecting drug absorption from the lung. 4.Subject has any active or chronic pulmonary disease as documented by history, physical examination or pulmonary function tests at screening. 5.Receipt of any investigational medicinal product within 30 days before randomisation in this trial. 6.Haemoglobin 3 x the upper limit of normal (ULN), and alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (?-GT) > 2 x ULN. 7. Smoker 8. Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •Comparison of the pharmacokinetic response after inhaled insulin administration with 3 different inhalation regimens (output mesh specifications) •Assessment of the relative bioavailability of inhaled insulin ;Secondary Objective: •Comparison of the relative pharmacokinetic (based on AUCINS,0-8h and CMAX,INS) properties of inhaled human insulin with subcutaneous insulin (Humalog®, insulin lispro) administration •Comparison of the postprandial glucose response after inhaled insulin administration with 3 different inhalation regimens •Comparison of the postprandial glucose response after inhaled insulin administration and subcutaneous insulin administration •To derive an estimate of the intravariability of PK and PD parameters with the medium output mesh insulin inhalation •Safety and tolerability of the inhaled insulin ;Primary end point(s): 1. AUCINS,0-8h, area under the insulin human / insulin lispro concentration-time curve 2. FREL, relative bioavailability of (inhaled) insulin human compared to (sc injected) insulin lispro;Timepoint(s) of evaluation of this end point: 1. from 0 to 8 hours 2. from 0 to 8 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary pharmacokinetic endpoints 1.AUCINS,0-1h, area under the insulin human / insulin lispro concentration-time curve 2. AUCINS,0-2h, area under the insulin human / insulin lispro concentration-time curve 3. AUCINS,2-8h, area under the insulin human / insulin lispro concentration-time curve 4. CMAX,INS 5. TMAX,INS 6. Onset of appearanceINS Secondary pharmacodynamic endpoints 1. ?AUCBG,0-1h, area under the blood glucose concentration-time curve 2. ?AUCBG,0-2h, area under the blood glucose concentration-time curve 3. ?AUCBG,0-8h, area under the blood glucose concentration-time curve 4. ?AUCBG,2-8h, area under the blood glucose concentration-time curve 5. ?BGMAX, maximum blood glucose excursion 6. BGMAX, maximum blood glucose concentration 7. TBG,MAX, time to maximum blood glucose concentration ;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 2 to 8 hours 4. maximum observed insulin human / insulin lispro concentration 5. time to maximum observed insulin human / insulin lispro concentration 6.time from trial product administration until the first time insulin human / insulin lispro concentration = LLOQ Secondary pharmacodynamic endpoints 1. from 0 to 1 hour after standard meal consumption 2. from 0 to 2 hours after standard meal consumption 3. from 0 to 8 hours after standard meal consumption 4. from 2 to 8 hours after standard meal consumption 5. after standard meal consumption 6. after standard meal consumption 7. after standard meal consumption | — |
Countries
Germany
Contacts
Public ContactDeborah Tranowski
Dance Pharmaceuticals, Inc.
Outcome results
None listed