Phase 3
N=589
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Diabetes, Type I
Bottom Line
View on ClinicalTrials.gov: NCT00308308 ↗Enrolled (actual)
589
Serious AEs
17.5%
Results posted
Oct 2014
Primary outcome: Primary: Compare the Mean Change From Baseline to Week 52 in HbA1c — -0.13; -0.37 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Technosphere Insulin (Drug); Active comparator (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mannkind Corporation
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare the Mean Change From Baseline to Week 52 in HbA1c |
-0.13; -0.37 | — |
| SECONDARY Change From Baseline in Weight to Week 52 |
-0.5; 1.4 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose to Week 52 |
-46.5; -25.7 | 0.0052 sig |
| SECONDARY Number of Subjects Achieving Week 52 HbA1c Levels Less Than or Equal to 7.0% |
33; 35 | 0.8311 |
| SECONDARY Incidence of Total Hypoglycemia |
85.67; 92.28 | 0.0124 sig |
| SECONDARY Incidence of Severe Hypoglycemia |
32.08; 36.40 | 0.2786 |
| SECONDARY Total Hypoglycemia Event Rate |
1.81; 1.86 | 0.1193 |
| SECONDARY Severe Hypoglycemia Event Rate |
0.08; 0.10 | 0.2131 |
Summary
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of type 1 diabetes for at least 1 year
- Nonsmokers for prior 6 months
- BMI less than or equal to 35kg/m2
- HbA1c > or = 7% and or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted
- Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
- Urine cotinine than 3 times the upper limit of normal
Data sourced from ClinicalTrials.gov (NCT00308308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.