A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients with Type 2 Diabetes Treated with Once-Daily Insulin Glargine - IDBA

• Conditions: Male or female nonsmoking patients 18 years of age or older; have had type 2 diabetes mellitus for at least 6 months at study entry and have been treated with one or more oral antihyperglycemic 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, have FEV1 and DLCO >70% predicted, and have an HbA1c between 7.5% and 9.5% at screening.; MedDRA version: 9.1Level: LLTClassification code 10012641Term: Diabetic

• Registration Number: EUCTR2006-000247-26-DE
• Lead Sponsor: Eli Lilly and Company Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 510

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 <20 ng/mL at screening.
[7] Are able to perform pulmonary function testing,
[8] Have PFTs graded as A,” B,” or C” in quality
[9] Have a chest x-ray without evidence of clinically significant pulmonary abnormalities
[10] 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified