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Clinical Trials/EUCTR2006-000247-26-GB
EUCTR2006-000247-26-GBActive, not recruitingNot Applicable

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

Eli Lilly and Company Ltd0 sites510 target enrollmentStarted: May 10, 2006Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
510
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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, based on the disease diagnosis
  • •criteria (Section 4.1.1), for at least 6 months’ duration at study entry,
  • •[3] Have been treated with the following regimen:
  • •one or more oral antihyperglycemic medications on a stable dose
  • •for at least 6 weeks (3 months for thiazolidinediones [TZDs])
  • •once-daily insulin glargine for at least 4 months
  • •[4] Have HbA1c =7.5 and =10.5% at screening
  • •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 except
  • •cotinine will be repeated.
  • •Retesting may occur as long as the screening period for the study is
  • •still ongoing at the time of the retest.
  • •Patients who were screened for this study prior to the approval of protocol amendment b and who failed to meet this inclusion criterion due to an HbA1c of > 9.5% may be rescreened if the screening HbA1c was also = 10.5%.
  • •[5] If female, are not breastfeeding
  • •If female and of childbearing potential (not surgically sterilized and
  • •between menarche and 1 year postmenopause), must
  • •test negative for pregnancy at the time of screening based on a
  • •urine or serum test,
  • •intend not to become pregnant during the study,
  • •agree to use a reliable method of birth control (for example, use of
  • •oral contraceptives or Norplant®; a reliable barrier method of birth
  • •control [diaphragms with contraceptive jelly; cervical caps with
  • •contraceptive jelly; condoms with contraceptive foam; intrauterine
  • •devices]; partner with vasectomy) during the study.
  • •[6] Are nonsmokers, have not smoked for at least 6 months prior to
  • •entering the study, and agree not to smoke (cigars, cigarettes, or pipes)
  • •or use smokeless tobacco for the duration of the study. Serum cotinine
  • •level must be <20 ng/mL at screening.
  • •If the patient is a nonsmoker for a period of =6 months, and the
  • •serum cotinine level is =20 and =100 ng/mL, the patient may
  • •undergo retesting of serum cotinine once within 4 weeks.
  • •Retesting may occur as long as the screening period for the study is
  • •still ongoing at the time of the retest.
  • •[7] Are able to perform pulmonary function testing, according to
  • •guidelines from the American Thoracic Society (ATS) (1995),
  • •[8] Have PFTs graded as A,” B,” or C” in quality (see Section 6.3.3.1)
  • •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 two acceptable DLCO maneuvers, two of which are
  • •reproducible (within 0.20 L for FEV1 and FVC; and within
  • •2.5 standard DLCO units for DLCO).
  • •o If the patients are not able to meet the reproducibility criteria
  • +7 more not shown

Exclusion Criteria

  • •Patients will be excluded from the study if they meet any of the following criteria:
  • •[11] Are investigative site personnel directly affiliated with the study,
  • •and/or their immediate families. Immediate family is defined as a
  • •spouse, parent, child, or sibling, whether biological or legally adopted.
  • •[12] Are Lilly or Alkermes employees,
  • •[13] 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
  • •[14] 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,
  • •[15] 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 the UK, patients who are on a TZD and glargine at study entry may be enrolled, if the patient is classified as NYHA I, and has been stable (from a cardiovascular perspective) while on this medication combination. In other
  • •countries where the combination of the TZD and insulin is not
  • •approved, patients taking any TZD at study entry will be excluded.
  • •[16] Have had more than two episodes of severe hypoglycemia during the
  • •6 months prior to study entry (see Section 5.9 for information about
  • •severe hypoglycemia),
  • •[17] Have had more than one hospitalization or emergency room visit due
  • •to poor diabetic control during the 6 months prior to study entry,
  • •[18] Have had a lower respiratory infection in the 3 months prior to
  • •screening, evidenced by diagnosed pneumonia (on clinical or
  • •radiologic grounds),
  • •[19] 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),
  • •[20] Have obvious clinical signs or symptoms of liver disease, acute or
  • •chronic active hepatitis, or alanine aminotransaminase/serum glutamic
  • •pyruvic transaminase (ALT/SGPT) greater than three times the upper
  • •limit of the reference range,
  • •[21] 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 (for example, in the United States, =1.5 mg/dL [132 µmol/L]
  • •for males or =1.4 mg/dL [123 µmol/L] for females),
  • •[22] Have a history of angina, myocardial infarction, or Functional Capacity Class II,III/IV cardiac disease (patients taking a TZD), Functional
  • •Capacity Class III/IV cardiac disease (patients not taking a TZD) (as defined by the New York
  • •Heart Association [Attachment IDBA.5]) within the 6 months prior to
  • •study entry.
  • •[23] 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 the cervix, or in situ
  • •prostate cancer) for less than 5 years,
  • •[24] Have a current or past history of lung cancer,
  • •[25] Have a history of lung transplantation,
  • •[26] Have a current diagnosis or past history of asthma, chronic obstructive
  • +1 more not shown

Investigators

Sponsor
Eli Lilly and Company Ltd

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