A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder HIIP Compared to Preprandial Injectable Insulin in Patients with Type 1 Diabetes Mellitus. - ND

Conditions: Type 1 Diabetes Mellitus
MedDRA version: 6.1Level: PTClassification code 10012601

Registration Number: EUCTR2006-000497-80-IT

Lead Sponsor: ELI LILLY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

1.Male and female patients who are 18 years of age or older. 2.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 3.Patients who have an HbA1c 8804;11 ; 4.Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months. 5.Patients who are a nonsmoker for at least 6 months prior to the study and intend to continue nonsmoking for the duration of the study. Serum cotinine level must be 20 ng/mL at screening; 6.Female patients who are not breastfeeding 7.Patients who have signed and dated the informed consent document. 8.Patients who are able to perform pulmonary function testing, according to guidelines from the American Thoracic Society ATS 1995 . 9.Patients who have PFTs graded as A, B, or C in quality and satisfy all of the following criteria for locally read PFTs DLCO 70 of predicted. FEV1/FVC lower limit of normal and FEV1 70 predicted. 10.Patients who have a chest x-ray with no evidence of clinically significant pulmonary abnormalities in the opinion of the investigator.
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

11.Patients who are investigative site personnel directly affiliated with the study, or are immediate family of investigative site personnel directly affiliated with the study 12.Patients who are employed by Lilly or Alkermes 13.Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time 14.Patients who have previously completed or withdrawn from this study or have previously received any form of inhaled insulin. 15.Patients who require a daily total insulin dosage greater than 150U at screening. 16.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. 17.Patients who have a history of lung transplantation 18.Patients who are diagnosed with pneumonia on clinical or radiological grounds in the 3 months prior to screening 19.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 20.Patients who have a history of renal transplantation, are currently receiving renal dialysis, or have a serum creatinine 2.0 mg/dL 177 956;mol/L . 21.Patients who have a history of angina, myocardial infarction, or Functional Capacity Class III/IV cardiac disease within the 6 months prior to study entry. 22.Patients who have had more than 2 episodes of severe hypoglycemia during the 6 months prior to study entry 23.Patients who have had more than 1 episode of diabetic ketoacidosis during the 6 months prior to study entry. 24.Patients who have had more than one hospitalization or emergency room visitdue to poor diabetic control during the 6 months prior to study entry 25.Patients who have a history of lung cancer 26.Patients who have active malignancy, other than basal cell or squamous cell skin cancer. 27.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 . 28.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. 29.Patients who fail to satisfy the investigator of suitability to participate for any other reason.