Diabetes Mellitus, Type 1
Conditions
Brief summary
To determine in subjects with Type 1 Diabetes Mellitus: 1. Whether glycemic control can be achieved at least as effectively with a) an intensive insulin regimen involving pre-meal inhaled insulin plus twice daily subcutaneous NPH insulin as with b) an intensive subcutaneous insulin regimen involving pre-meal regular insulin plus twice daily NPH, given as 4 injections per day. The treatment regimens differ only by the route of delivery of the short acting insulin. 2. The toleration and safety of inhaled insulin therapy and its effects after 6months, if any, on measures of pulmonary function.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 Diabetes for more than 1 year * Stable insulin regimen of at least 2 injections per day
Exclusion criteria
* Any smoking within the last 6 months. Smoking is not permitted at any time during this study. * Subjects on insulin pump during 2 months prior to screening. * Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is 24 week change in baseline in HbA1c. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include the following efficacy assessments: | — |
| Incidence of hypoglycemia | — |
| Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%) | — |
| Change from baseline in fasting lipid profile | — |
| Change from baseline in fasting plasma glucose level | — |
| Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose) | — |
| Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study). | — |
| Change from baseline in body weight | — |
| Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments). | — |
| Patient satisfaction and preference. | — |
Countries
Canada, United States
Outcome results
None listed