Type 2 diabetes mellitus MedDRA version: 7 Level: LLT Classification code 10012601
Conditions
Interventions
Trade Name: Exubera 1 mg
Product Name: Exubera (inhaled insulin)
Product Code: CP-464005
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin human
Current Sponsor code:
Sponsors
Pfizer Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients meeting all criteria listed below will be included in the study: 1. Age = 35 years and = 80 years with a 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). 2. HbA1c = 8.0% at screening. 3. Body Mass Index (BMI) =23 kg/m2 and = 40 kg/m2 (See BMI Table Appendix E). 4. Patients must have documentation of a fully dilated ophthalmologic exam performed within 1 year of screening in accordance with local guidelines. The documentation must be obtained prior to randomization. This information is of importance e.g., in case proliferative retinopathy is diagnosed while aggressive glucose lowering is considered in the study. 5. Currently treated and on a stable dose of at least two oral hypoglycemic agents for at least 3 months prior study entry with at least half maximum dose per country guidelines or half maximum tolerable dose. 6. Written informed consent obtained PRIOR to performing screening evaluations. 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: 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 or discontinued from insulin within the past three months 5. “Brittle” diabetes or a predisposition to severe hypoglycemia. Severe hypoglycemia is defined in Section 10.11.2. of the protocol. 6. Metabolic Conditions: a) Significant hypoglycemia risk b) Current chronic inhaled or systemic corticosteroid treatment likely to be of metabolic effect 7. Active Liver disease 8. Pulmonary Conditions: a) Frankly abnormal PFTs at Week –1, defined as DLco >120% or 130% or 180 mmHg, diastolic blood pressure > 110 mmHg) on two readings (sitting). c) Abnormal screening ECG: i) predominant rhythm other than normal sinus ii) A-V block greater than first degree iii) resting heart rate > 100 or 50 mg/dl, whichever is worse. 11. Psychological a) History of substance abuse or alcoholism within the past 5 years b) Psychiatric disorders that would interfere with the patient’s ability to complete the study 12. Neurological a) Seizure disorder b) Significant gastroparesis or orthostatic hypotension (autonomic neuropathy) 13. Any current malignancy except: a) those = 5 years ago without recurrence b) excised basalioma or squamous cell cancer 14. Clinically significant abnormalities on screening laboratory evaluation 15. Clinically significant major organ system disease 16. Patients with circumstances or abnormalities (e.g., blindness or a history of non-compliance) that would interfere with the interpretation of safety or efficacy data or the completion of the study 17. Unable and/or unlikely to comprehend and/or follow the study protocol (including blood glucose monitoring) and complete Patient Reported Outcomes questionnaire. Unable and/or unlikely to comprehend how to use the inhaler device or inability to use the inhaler device 18. Failure to adhere to protocol requirements during the run-in period 19. Pregnant or intent to become pregnant OR BREASTFEEDING during study or absence of adequate birth control measures 20. Inpatient surgery anticipated during the study period 21. Known interference with HbA1c determination: hemoglobinopathy or chronic anemia 22. Investigator or immediate family 23. Donation of blood or blood
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that mean reduction in HbA1c after 26 weeks (approx. 6 months) is greater in patients to whom inhaled insulin is made available compared to patients to whom it is not.;Secondary Objective: Secondary endpoints which will be assessed at endpoint (12 months) and at week 26 (approx. 6 months) as part of an interim analysis: · HbA1c at week 52, ITT population · Proportion of patients achieving glycemic control (HbA1c = 6.5%, = 7.0%) · The time it takes to get to “be treated with” insulin (inhaled or SC) · Change from baseline in fasting plasma glucose level · Incidence and severity of hypoglycemia · Change from baseline in body weight and body mass index · Change from baseline in fasting lipid profile · Treatment categories: Inhaled insulin, SC insulin, changed oral agents, no change in treatment choice. · Number of patients who discontinue due to insufficient clinical response · Pulmonary function · Insulin antibody titers · Incidence of clinical adverse events · Pharmaco-economic impact ;Primary end point(s): The primary objective of this study is to demonstrate that mean the reduction in HbA1c after 26 weeks (approx. 6 months) of treatment is greater in patients to whom inhaled insulin is made available compared to patients to whom it is not. Thus, the primary efficacy variable is the difference in HbA1c between baseline (Week -2) and the end of the treatment period at week 52, in the intention-to-treat (ITT) population | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed