A 16 WEEK OPEN-LABEL OUTPATIENT, RANDOMIZED, PARALLEL STUDYASSESSING THE IMPACT OF TWO DIFFERENT INITIAL DOSE PRESCRIPTIONS FOR DRY POWDER INHALED INSULIN (EXUBERA®) ON GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE POORLY CONTROLLED ON A COMBINATION OF TWO OR MORE ORAL AGENTS
- Conditions
- Diabetes mellitus Type 2MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus
- Registration Number
- EUCTR2006-007034-36-SI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 424
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
trial:
1. Signed informed consent.
2. Age = 18 years
3. Diagnosis of type 2 diabetes made = 6 months prior to study entry, as defined by
the American Diabetes Association (Diabetes Care 25:S5-S20, 2002).
4. HbA1c = 7.0% at screening
5. Patient should be currently treated and on a stable dose of at least two oral
hypoglycemic agents for at least 3 months prior to study entry.
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
Subjects presenting with any of the following will not
be included in the trial:
1. Type 1 diabetes
2. Known allergy to insulin
3. Smoking: current or any in the past 6 months; smoking is not permitted at any
time during the study
4. Current treatment with insulin
5. Current chronic inhaled or systemic corticosteroid treatment likely to be of
metabolic effect (prednisone equivalent >2 mg/day); intercurrent treatment at a
higher dose is allowed if treatment duration does not exceed 2 weeks
6. Active Liver disease; ALT = 1.5 times the upper limit of normal (ULN) reference
range for the central lab at screening. Evidence within the preceding six months of
hepatic dysfunction e.g., AST, ALT, two and a half (2.5) times the upper limit of
normal or hepatic disease, e.g., hepatitis,jaundice, cirrhosis or history of
developing abnormal liver function tests (LFTs) on thiazolidinediones. Patients
with an elevated ALT = 1.5 times ULN due to hepatic steatosis are permitted to
enter the study.
7. Pulmonary Conditions:
• Less than 70% of predicted FEV1 at Visit 1
• Significant pulmonary diseases including poorlycontrolled asthma, clinically
significant obstructive pulmonary disease or other significant respiratory disease.
8. Cardiovascular conditions:
• Significant cardiovascular dysfunction and/or history including hospitalization
within the preceding six months, e.g., congestive heart failure or serious
arrhythmia, myocardial infarction, cardiac surgery,recurrent syncope, transient
ischemic attacks or cerebrovascular accident.
• Poorly-controlled hypertension (systolic blood pressure >180 mmHg, diastolic
blood pressure >110 mmHg) on two readings (sitting).
• Abnormal screening ECG: predominant rhythm other than normal sinus A-V
block greater than first degree resting heart rate > 100 or < 50 bpm. The
principal investigator, or other designated physician at each site, will be
responsible for deciding the clinical significance of any abnormal ECG findings.
9. Kidney disease:
• History of renal transplantation or current renal dialysis
• Clinical nephrotic syndrome, or significant renal dysfunction or disease based
on estimated creatinine clearance < 65 mL/min (25), and/or a serum creatinine
greater or equal to 1.5 mg/dl (133 mmol/L) in males and greater or equal to 1.4
mg/dl (124mmol/L) in females and /or BUN >50 mg/dl, whichever is worse.
10. Any other clinically significant abnormalities on screening laboratory evaluation
(unless discussed with and approved by a Pfizer clinician)
11. History of substance abuse or alcoholism within the past 5 years, and psychiatric
disorders that would interfere with the patient’s ability to complete the study
12. Any current malignancy except:
• those = 5 years ago without recurrence excised
• basalioma or squamous cell cancer
13. Clinically significant major organ system disease such as active infection (e.g.,
HIV, Hepatitis), or history of severe infection, during the 30 days prior to
screening Any concurrent illness other than diabetes mellitus not controlled by a
stable therapeutic regimen
14. Patients with circumstances or abnormalities (e.g.,blindness or a history of
noncompliance) that would interfere with the interpretation of safety or efficacy
data or the completion of the study
15. Preg
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