Male or female nonsmoking patients 18 years of age or older
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] Are male or female who are 18 years of age or older, [2] Have had type 2 diabetes mellitus for at least 6 months’ duration at study entry, [3] Have been treated with the following regimen: one or more oral anti-hyperglycemic medications on a stable dose for at least 6 weeks (3 months for thiazolidinediones [TZDs]) AND once-daily insulin glargine for at least 4 months [4] Have HbA1c =7.5 and =10.5% at screening [5] If female, are not breastfeeding AND If female and of childbearing potential 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 [6] Are nonsmokers, have not smoked for at least 6 months prior to entering the study, and agree not to smoke. Serum cotinine level must be =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: [1] Are investigative site personnel directly affiliated with the study, and/or their immediate families. [2] Are Lilly or Alkermes employees [3] 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regulatory approval for any indication at the time of study entry [4] Patients who have previously completed or withdrawn from this study or any study investigating any form of inhaled insulin and took one or more doses of inhaled insulin, or have previously taken any form of inhaled insulin [5] Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label in the respective country (for example, 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] Have had more than two episodes of severe hypoglycemia during the 6 months prior to study entry [7] Have had more than one hospitalization or emergency room visit due to poor diabetic control during the 6 months prior to study entry, [8] Have had a lower respiratory infection in the 3 months prior to screening, evidenced by diagnosed pneumonia [9] 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] 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] 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 [12] Have a history of angina, myocardial infarction, or Functional Capacity Class III/IV cardiac disease within the 6 months prior to study entry, [13] Have an active or untreated malignancy, or have been in remission from a clinically significant malignancy for less than 5 years [14] Have a current or past history of lung cancer [15] Have a history of lung transplantation [16] Have a current diagnosis 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, [17] Are taking or have taken exenatide (Byetta™) within 6 weeks, [18] Require more than 150 U/day of insulin glargine, [19] Have any other condition (including reported drug abuse, alcohol abuse, or psychiatric disorder) that, in the opinion of the investigator, precludes the patient from following and completing the protocol, [20] 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 compare, in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once-daily insulin glargine, a regimen including mealtime HIIP without insulin glargine (“HIIP only” group) versus a regimen including intensified insulin glargine without mealtime HIIP (“intensified glargine” group), with respect to mean change in HbA1c from baseline to endpoint (6 months). Superiority with respect to HbA1c will be concluded if the upper limit of the 95% confidence interval for the treatment difference (“HIIP only” minus “intensified glargine”) is less than zero. Noninferiority will be concluded if this upper limit is less than 0.4%, but greater than or equal to 0.0%. ;Secondary Objective: The secondary objectives of the study are: • To compare the “HIIP only” group versus the “intensified glargine” group, “HIIP + intensified glargine” group versus the “intensified glargine” group, and the “HIIP + intensified glargine” group versus the “HIIP only” group, with respect to the following after 24 weeks and 52 weeks (if applicalbe) of treatment: mean change in HbA1c from baseline to various timepoints, the proportion of patients achieving HbA1c <7%, achieving HbA1c less or equal 6.5%, insulin dose requirements, hypoglycemia, and treatment-emergent adverse events. • To compare the “intensified glargine” group (no HIIP exposure) versus the “HIIP exposure” group (“HIIP only” and “HIIP + intensified glargine” groups combined) with respect to the following after 24 weeks and 52 weeks (if applicable) of treatment: safety as assessed by insulin antibody levels; pulmonary function testing (PFT) • To assess inhaler reliability in patients randomized to treatment with HIIP.;Primary end point(s): Efficacy: The primary efficacy measure is the HbA1c change from baseline to 6 months between the “HIIP only” and “intensified glargine” groups. The secondary measures of t | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed