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 an insulin regimen involving pre-meal inhaled insulin plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2-3 mixed Regular/NPH insulin injections per day. 2. The toleration and safety of inhaled insulin therapy and its effects after 6 months, 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 |
|---|---|
| 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 | — |
| The secondary endpoints include the following efficacy assessments: | — |
| 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. | — |
| Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose) | — |
Countries
Canada, United States
Outcome results
None listed