Male or female adults (>18 yrs), diagnosed type 2 diabetes mellitus for at least 6 months duration at study entry, taking at least one oral anti-hyperglycemic medication and are insulin-naïve. They should have a HbA1c =6.5% and =10.0% at the time of 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: [1] Male or female patients who are 18 years of age or older [2] Patients who have had type 2 diabetes mellitus for at least 6 months [3] Patients taking at least one oral anti-hyperglycemic medication [4] Patients with HbA1c =6.5% and =10.0% at screening [5] Female patients who are not breastfeeding, tested negative for pregnancy at the time of screening and do not intend to become pregnant during study. [6] Patients who are nonsmokers, have not smoked for at least 6 months prior to entering the study, and agree not to smoke for the duration of 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 Pulmonary function tests (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 three acceptable FEV1, FVC, and DLCO maneuvers [9] Patients who have a chest x-ray without evidence of clinically significant pulmonary abnormalities (including severe bullous disease), in the opinion of the investigator. [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: [1] Patients who are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. [2] Patients who are employed by Lilly or Alkermes. Immediate family of Lilly or Alkermes employees may participate in Lilly sponsored clinical trials, but are not permitted to participate at a Lilly facility. [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 any study investigating any form of inhaled insulin and took one or more doses of inhaled insulin [5] patients who are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label in the respective country (e.g., in the United States, rosiglitazone greater than 4 mg daily or pioglitazone greater than 45 mg daily is not currently indicated). In countries where the combination of the TZD and insulin is not approved, patients taking any TZD at study entry will be excluded. [6] Patients who have had more than two episodes of severe hypoglycemia during the 6 months prior to study entry. [7] Patients who have had more than one hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry. [8] Patients who have had a lower respiratory infection in the 6 months prior to screening, evidenced by diagnosed pneumonia. [9] 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) [10] 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 [11] 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) if not on metformin; or if on metformin at study entry, have a serum creatinine above what is contraindicated in the metformin label in the respective country (e.g., in the United States, more than or equal 1.5 mg/dL [132 µmol/L] for males or more than or equal 1.4 mg/dL [123 µmol/L] for females) [12] Patients who have a history of angina, myocardial infarction (MI), or Functional Capacity Class III/IV cardiac disease (as defined by the New York Heart Association [Protocol Attachment IDAU.5]) within the 6 months prior to study entry [13] Patients who have an active or untreated malignancy, or have been in remission from a clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinoma of t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is to test the hypothesis that in insulin-naïve patients with type 2 diabetes not optimally controlled by oral anti-hyperglycemic medication, preprandial HIIP is noninferior to preprandial injectable insulin (insulin lispro) with respect to mean change from baseline to endpoint in HbA1c at 6 months. A noninferiority margin of 0.4% for HbA1c is used.;Secondary Objective: 1) To test the hypothesis that preprandial HIIP is noninferior to preprandial injectable insulin (insulin lispro) with respect to mean change from baseline to endpoint in HbA1c at 12 months and at 24 months. 2) To compare preprandial HIIP with preprandial injectable insulin (insulin lispro) in patients with type 2 diabetes who have been treated for approximately 6, 12, and 24 months. 3) To compare two dose titration methods at 6 months. 4) To assess inhaler reliability in patients randomized to treatment with HIIP. 5) To assess the pharmacokinetics of HIIP administered preprandially to a subgroup of patients. ;Primary end point(s): The primary efficacy measure of this study is the mean HbA1c change from baseline measured at 6 months. | — |
Countries
Germany, Hungary, Italy, Portugal
Outcome results
None listed