A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial InjectableInsulin in Insulin-Naïve Patients with Type 2 Diabetes Mellitus - IDA
- Conditions
- 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.
- Registration Number
- EUCTR2005-004747-64-PT
- Lead Sponsor
- Eli Lilly and Company Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
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
[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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method