Patients with type 1 diabetes mellitus and many patients with type 2 diabetes mellitus require daily use of insulin for the maintenance of normal glucose homeostasis. At present, insulin can be delivered only by injection. The availability of noninjectable routes of insulin administration may eliminate a barrier to effective therapy and improve the quality of life for many patients with diabetes.
Conditions
Sponsors
Eli Lilly Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female patients who are 18 years of age or older. - Patients who have type 1 diabetes for at least 24 months’ duration at study entry and meet the disease diagnostic criteria as defined by the World Health Organization (WHO) and as confirmed by a C-peptide value 1 year, and the serum cotinine level is >20 and 70% of predicted. FEV1/FVC > lower limit of normal and FEV1 >70% predicted. Patients should be able to perform at least 3 acceptable FVC and DLCO maneuvers, 2 of which are reproducible - Patients who have a chest x-ray with no evidence of clinically significant pulmonary abnormalities in the opinion of the investigator. (Scarring due to inactive tuberculosis is not exclusionary.) - Patients who are able to perform pulmonary function testing, according to guidelines from the American Thoracic Society (ATS 1995). - Patients who are able to perform the 6MWT. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. - Are employed by Lilly or Alkermes (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. - Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. - Patients who have previously completed or withdrawn from this study or any study investigating any form of inhaled insulin. - Patients who require a daily total insulin dosage greater than 150 U at screening. - Patients who have a current or past history of asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, or other clinically relevant pulmonary disease that in the opinion of the investigator would preclude participation in the study due to safety concerns, or confound data interpretation. - Patients diagnosed with pneumonia (on clinical or radiological grounds) in the 3 months prior to screening. - Patients who have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransaminase/serum glutamic pyruvic transaminase (ALT/SGPT) greater than three times the upper limit of the reference range. - Patients with a history of renal transplantation, are currently receiving renal dialysis, or have a serum creatinine >2.0 mg/dL (177 µmol/L). - Patients who have a body mass index (BMI) >35 kg/m2. - Patients with a history of angina, myocardial infarction (MI), or Functional Capacity Class III/IV cardiac disease within the 6 months prior to study entry. - Patients who have had more than 2 episodes of severe hypoglycemia during the 6 months prior to study entry. - Patients who have had more than 1 episode of diabetic ketoacidosis during the 6 months prior to study entry. - Patients with a history of lung cancer. - Patients with active malignancy, other than basal cell or squamous cell skin cancer. - Patients who have received systemic glucocorticoid therapy within the 3 months prior to study entry (topical preparations, nasal preparations, intra-articular administration, as well as physiologic replacement for Addison’s Disease and hypopituitarism are permitted). - Patients who have any other condition (including known drug abuse, alcohol abuse, or psychiatric disorder) that, in the opinion of the investigator, precludes the patient from following and completing the protocol. - Patients who fail to satisfy the investigator of suitability to participate for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that preprandial HIIP is noninferior to preprandial injectable insulin (regular human insulin or insulin lispro) with respect to mean change from baseline to endpoint in HbA1c in patients with type 1 diabetes treated for approximately 24 months. A noninferiority margin of 0.4% for HbA1c will be used.;Primary end point(s): The primary outcomes of this study will be the efficacy measure HbA1c change from baseline to endpoint and the assessment of HIIP effects on important safety parameters.;Secondary Objective: 1) To compare preprandial HIIP with preprandial injectable insulin in patients with type 1 diabetes with respect to: - FEV1, FVC and total lung capacity - DLCO - Safety assessed by insulin antibody titers, AEs, episodes of hypoglycemia - Safety using qualitative visual reading of serial HRCT scans of chest - Safety assessed by Six-Minute Walk Test with Borg CR10 scale to assess perceived exertion - Glycemic control assessed by the 8-point self blood glucose monitoring profiles - Proportion of patients who achieve or maintain an HbA1c <7.0% - Insulin dose requirements - Patient-reported outcomes questionnaires to assess psychological well being, health status, and insulin delivery system satisfaction - Resource utilization 2) To assess inhaler reliability in patients randomized to treatment with HIIP 3) To explore differences in cough and other pulmonary symptoms in patients treated with HIIP or preprandial injectable insulin using the PSQ | — |
Countries
Hungary
Outcome results
None listed