Diabetes mellitus Type 2 MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Trade Name: Exubera
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin Human
CAS Number: 11061-68-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is noninferior compared to the standard weight-based formula.;Secondary Objective: To assess • Speed of achieving a stable prescribed dose • Glucose control at 16 weeks • Incidence of hypoglycemia during the first 4 weeks and over 16 weeks • Safety and tolerability of Exubera;Primary end point(s): • Primary: Change in HbA1c from baseline after 16 weeks of treatment. Secondary: • Time from initial to stable prescribed dose for Exubera*. • Change from baseline in fasting plasma glucose at week 1, 2, 4, 8, 12 and 16. • Change from baseline in mean average blood glucose based on 7-point blood glucose profile collected at week 1, 4, 8 and at 16 • Proportion of subjects achieving HbA1c < 7.0% or < 6.5% at week 16 • Incidence of overall and severe hypoglycemia collected at baseline (week 0) and at week 1, 2, 4, 8, 12 and 16 • Incidence of nocturnal hypoglycemia collected at baseline (week 0) and at week 1, 2, 4, 8, 12 and 16 • Safety and tolerability of Exubera *Stable prescribed dose will be defined in two ways, each applied to the whole study population, as follows: 1. Exubera Total Daily Dose prescribed by a study health care professional that has remained unchanged for at least 3 consecutive assessments. 2. Exubera Total Daily Dose prescribed by a study health care professional that has remained unchanged for at least 4 weeks. | — |
Countries
Slovenia
Outcome results
None listed