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.
Conditions
Sponsors
Eli Lilly and Company Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Efficacy: The primary efficacy measure is the HbA1c change from baseline to 6 months. The secondary measures of the study are as follows: 8-point SBGM profiles (blood glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, blood glucose measurements at bedtime and 3 a.m.); and proportion of patients who achieve or maintain an HbA1c =6.5% and <7.0%; daily insulin dose requirements (total, preprandial, and basal insulin). Exploratory measures will include second-hand smoking questions. HIIP Delivery System: Insulin inhaler reliability will be assessed by laboratory assessment of inhalers returned for patient complaint. Safety Measures: Insulin antibody levels (cross-reactive antibodies, insulin-specific antibodies, lispro-specific antibodies, antibody classes); change from baseline in pulmonary function tests (FEV1, FVC, TLC, DLCO); change from baseline in cough and other pulmonary symptoms using the PSQ; hypoglycemic episodes; treatment-emergent adverse events; laboratory tests; vital signs (body temperature, systolic blood pressure, diastolic blood pressure, pulse rate, and respiratory rate); and body weight. Pharmacokinetic: Serum free immunoreactive insulin (IRI) concentrations in up to 5 blood samples collected from a subgroup of approximately 120 patients in the HIIP treatment group at Visits 5 and 6. Visit 5 includes the consumption of a standard meal. Health Outcomes: Patient-reported general well-being, diabetes-associated symptoms, diabetes treatment satisfaction, and evaluation of insulin delivery systems using the 12-item Well-Being Questionnaire (W-BQ12); the Cognitive Distress, Fatigue, Hyperglycemia, and Hypoglycemia Subscales of the Diabetes Symptom Checklist-Revised (DSC-R); the Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs); and the Insulin Delivery System Questionnaire (IDSQ), respectively. ;Main Objective: The primary objective of this study is t | — |
Countries
Belgium, Germany, Italy
Outcome results
None listed