Phase 3
Completed N=528
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00332488 ↗Enrolled (actual)
528
Serious AEs
3.0%
Results posted
Oct 2014
Primary outcomePrimary: Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue — -0.78; -0.70 Percentage of total hemoglobin — p=0.420
Summary
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue |
-0.78; -0.70 | 0.420 |
| SECONDARY Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue |
0.12; -0.76 | < 0.001 sig |
| SECONDARY Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment) |
-1.82; -1.23; -1.68 | — |
Eligibility Criteria
Inclusion Criteria
- Non-smokers with clinical diagnosis of Type 2 diabetes mellitus for >or= to 6 months
- Stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue or= to 7.5% and or = to 70%, Total Lung capacity and > or =80% DLco > or= to 70%
Exclusion Criteria
- Treatment with any type of anti-diabetic therapy, other than metformin & secretagogues within the preceding 12 weeks
- Serum creatinine > 1.4mg/dL in female subjects and >1.5mg/dL in male subjects
- History of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
- Evidence of serious complications of diabetes (e.g. autonomic neuropathy)
Data sourced from ClinicalTrials.gov (NCT00332488). 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. Informational only — not medical advice.