A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial InjectableInsulin in Patients with Type 1 Diabetes Mellitus - IDAV
- Conditions
- Male or female nonsmoking patients 18 years of age or older who have had type 1 diabetes mellitus for at least 24 months at study entry and are taking at least 2 or 3 preprandial injections per day for at least 2 months, have FEV1 and DLCO >70% predicted, and have an HbA1c less or equal 11.0% at screening.
- Registration Number
- EUCTR2006-000497-80-BE
- Lead Sponsor
- Eli Lilly and Company Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 320
Patients are eligible to be included in the study only if they meet all of the following
criteria at screening or otherwise as described below:
[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 =11%;
• If the HbA1c criterion is not met at the first screening visit, the patient may undergo retest of HbA1c once within a 3-month period. If less than 1 month has passed since the initial screening, only the HbA1c test will be repeated. If more than 1 month but less than 3 months have passed, the entire screening panel will be repeated, except for cotinine.
• One retest may occur as long as the screening period for the study is still ongoing at the time of the retest.
[4] patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months (Patients who are on a regimen that includes premix insulin are appropriate candidates. Patients on insulin pump therapy within the previous 2 months are not appropriate candidates.)
[5] patients who are nonsmokers 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,
and
if female patients are of childbearing potential they must:
test negative for pregnancy at the time of screening
• intend not to become pregnant during the study
• agree to use a reliable method of birth control during the study.
[7] patients who are able to perform pulmonary function testing, according to guidelines from the American Thoracic Society (ATS 1995)
[8] patients who have PFTs graded as A,” B,” or C” in quality and satisfy all of the following criteria for PFTs:
• DLCO >70% of predicted
• FEV1/FVC >lower limit of normal and FEV1 >70% predicted
• Patients should be able to perform at least 3 acceptable FEV1, FVC, and DLCO maneuvers.
• If the grade for FEV1, FVC, or DLCO is D” or F,” then the patient may retest within a 4-week period.
• Retesting may occur as long as the screening period for the study is still ongoing at the time of the retest.
[9] 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.)
[10] patients who have signed and dated the informed consent document.
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
Patients will be excluded from the study if they meet any of the following criteria at
screening:
[1] patients who are investigative site personnel directly affiliated with the study, or are immediate family of investigative site personnel directly affiliated with the study.
[2] patients who are employed by Lilly or Alkermes. Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child,
or sibling, whether biological or legally adopted.
[3] 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 of study entry
[4] patients who have previously completed or withdrawn from this study or have previously received any form of inhaled insulin
[5] patients who require a daily total insulin dosage greater than 150 U at screening
[6] patients who have a current or past history of asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, 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
[7] patients who have a history of lung transplantation
[8] patients who are diagnosed with pneumonia (on clinical or radiological
grounds) in the 3 months prior to screening
[9] 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 3 times the upper limit of the reference range
[10] patients who have a history of renal transplantation, are currently
receiving renal dialysis, or have a serum creatinine >2.0 mg/dL (177 µmol/L)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method