Type 2 diabetes mellitus MedDRA version: 8.0 Level: LLT Classification code 10012601
Conditions
Interventions
Product Name: Insulin Dry Powder Pulmonary Inhaler (Exubera®)
Product Code: CP-464,005
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin human
Current Sponsor code: C
Sponsors
PFIZER,S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has given written informed consent to participate in the study. 2. Age =35 years and =80 years with a diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association (Diabetes Care 25: S5-S20, 2002)made at least 6 months prior to screening. 3. Has a screening HbA1c =8% and =11.0%. 4. Has a Body Mass Index (BMI) =23 kg/m 2 and =40 kg/m 2 , calculated using the following formula BMI = Weight in Kilograms (Height in Meters) x (Height in Meters) or BMI = ( Weight in Kilograms ) x 10,000 (Height in centimeters) x (Height in centimeters) 5. Is currently treated and on a stable dose of two OHA’s for at least 3 months prior to study entry. 6. Has documentation of a full ophthalmologic exam (including fundoscopy) by an ophthalmologist within 6 months prior to randomization. 7. Is willing and able to perform specified home blood glucose monitoring (HBGM) and to otherwise comply with study protocol requirements. 8. Has the ability to understand the requirements of the study. 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. Has Type 1 Diabetes mellitus as defined by American Diabetes Association (ADA) criteria. 2. Has Type 2 diabetes chronically treated with insulin regimen (only, or in combination with OHA’s). 3. Has Type 2 diabetes and is not treated with OHA or treated with only one OHA, or those treated with OHA’s that are prohibited for use in combination with other OHA’s or with insulin as per country specific labeling requirements for such agents. 4. Is currently treated with TZD’s. Subject will be allowed to enter the study after a 12-week wash out period. 5. Has a known allergy to insulin. 6. Has a "brittle" diabetes or a predisposition to severe hypoglycemia 7. Has any of the following metabolic conditions: •Significant hypoglycemia risk e.g., history of >2 severe (as defined by DCCT) hypoglycemic episodes within past 6 months •Known adrenal insufficiency •Symptomatic autonomic neuropathy and/or •Current chronic 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. Corticosteroids given topically and as intra-articular injections are allowed during the course of the trial 8. Has an impaired hepatic function, as shown by, but not limited to, ALT (SGPT) or AST (SGOT) above 2x the upper limit of normal as measured at visit 1. 9. Has an impaired renal function, as shown by, but not limited to, serum creatinine >177 µmol/l (>2 mg/dl) as measured at visit 1 or current renal dialysis. 10. Has any other clinically significant abnormalities on screening laboratory evaluation 11. Has hemoglobinopathy or chronic anemia or any other condition known to interfere with HbA1c determination. 12. Has active proliferative diabetic retinopathy 13. Has donated blood or had a transfusion of blood/blood products during the trial and 2 months prior to screening. 14. If the subject is female who is pregnant, lactating or planning to become pregnant during the study. 15. Has any of the following pulmonary conditions: •Frankly abnormal FEV1 at Week –1, defined as FEV1 <70% of predicted. •Clinically significant abnormalities on screening chest X-ray (or chest MRI). 16. Is unable to perform assessment of FEV1 according to predefined quality criteria following American Thoracic Society (ATS) or local country specific guidelines. 17. Has smoked within the last 6 months prior to entry in the study. Smoking is not permitted at any time during this study. 18. Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. 19. Has any clinically significant major organ system disease such as relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, haematological or other major systemic diseases which, in the investigator’s opinion, make implementation of the protocol or interpretation of the study results difficult. Well controlled, stable disorders such as essential hypertension and complications directly related to diabetes (such as peripheral neuropathy, mild nephropathy or stable retinopathy) would not exclude a subject. 20. Has an active infection (e.g., HIV, hepatitis), or a history of severe infection, during the 30 days prior to screening. 21. Is being treated or likely to require treatment during the study period with drugs not permitted by the clinical study protocol. 22. Has participatied in any other studies involving investigational or mar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy between subjects who are treated with the combination of OHA’s and Exubera® compared to subjects treated with usual diabetes care, by looking at the mean reduction in HbA1c after 24 weeks in both groups.;Secondary Objective: The secondary objective is to further explore the efficacy, safety and humanistic impact by evaluating the following secondary endpoints: •Proportion of subjects achieving good glycemic control (HbA1c =6.5% and =7.0%). •Time to achieve glycemic control (HbA1c =6.5% and HbA1c =7.0%). •Change from baseline to end of treatment in fasting plasma glucose (FPG) level. •Time course of change in fasting plasma glucose levels. •Incidence and severity of hypoglycemia. •Change from baseline to end of treatment in body weight and body mass index. •Change from baseline to end of treatment in fasting lipid profile. •Number of subjects who require additional treatment 12 weeks after randomization. •Number of subjects who discontinue due to insufficient clinical response. •Change from baseline to end of treatment in pulmonary forced expiratory volume in one second (FEV1). •Incidence and severity of clinical adverse events. •Subject reported treatment satisfaction and health status.;Primary end point(s): Diabetes–related Endpoints : The primary efficacy endpoint will be change from baseline in HbA1c at the end of the treatment period. Secondary endpoints include the percentage of subjects who have an HbA1c of =7% and =6.5% at the end of the treatment period, rates of hypoglycemia, changes in body weight at week 24 compared to baseline, time to achieve good control - an HbA1c of =7% and =6.5%. Safety Endpoints: Clinical laboratory tests, pulmonary and liver function tests, vital signs and clinical adverse events including hypoglycemia will be evaluated. | — |
Countries
Greece, Portugal, Spain, Sweden
Outcome results
None listed