Phase 4
Completed N=257
A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
Source: ClinicalTrials.gov NCT00391027 ↗Enrolled (actual)
257
Serious AEs
7.0%
Results posted
Oct 2009
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 — -1.7; -1.4 percent
Summary
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 |
-1.7; -1.4 | — |
| SECONDARY Change From Baseline in HbA1c Prior to Week 26 |
-0.4; -0.3; -0.8; -0.6; -1.3; -1.1 | — |
| SECONDARY Number of Subjects With HbA1c < 6.5 % |
37; 23 | — |
| SECONDARY Number of Subjects With HbA1c < 7.0 % |
84; 67 | — |
| SECONDARY Number of Subjects With HbA1c < 8.0 % |
121; 108 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) Level |
-30.6; -60.1 | — |
| SECONDARY Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) |
-45.0; -43.7; -38.1; -50.7; -64.5; -49.6 | — |
| SECONDARY Number of Subjects With Hypoglycemic Events by Severity |
26; 32; 1; 1 | — |
| SECONDARY Number of Events of Nocturnal Hypoglycemia |
159; 81 | — |
| SECONDARY Change From Baseline in Body Weight |
2.2; 1.1 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
0.7; 0.4 | — |
| SECONDARY Number of Subjects Discontinued Due to Insufficient Clinical Response |
3; 0 | — |
| SECONDARY Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health |
— | — |
| SECONDARY Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients |
107.6; 102.1; 33.7; 30.7 | — |
| SECONDARY Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP) |
0.2; -0.1 | — |
| SECONDARY Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6) |
-1.1; -2.4 | — |
| SECONDARY Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes) |
-3.4; -40.4 | — |
| SECONDARY Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF) |
230.2; 170.4 | — |
| SECONDARY Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diabetes Mellitus, Type 2 on oral agents
- Age > 30 years
Exclusion Criteria
- Severe Asthma, severe Chronic Obstructive Pulmonary Disease
- Smoking
Data sourced from ClinicalTrials.gov (NCT00391027). 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.