Phase 4
N=413
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT00418522 ↗Enrolled (actual)
413
Serious AEs
—
Results posted
Sep 2009
Primary outcome: Primary: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population — -2.01; -1.75 percent — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin glargine (Drug); Inhaled Insulin (Exubera) (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population |
-2.01; -1.75 | <0.0001 sig |
| SECONDARY Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26 |
35.5; 22.2 | 0.0052 sig |
| SECONDARY Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26 |
62.6; 47.6 | 0.0022 sig |
| SECONDARY Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26 |
79.8; 83.6 | 0.2480 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 26 |
-52.77; -53.50 | 0.6091 |
| SECONDARY Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26 |
-35.22; -61.16; -49.91; -66.02; -56.83; -64.77 | <0.0001 sig |
| SECONDARY Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26 |
-86.61; -75.36; -86.66; -58.51; -81.86; -59.20 | 0.1207 |
| SECONDARY Change From Baseline in Lipids at Week 26 |
-2.80; -6.19; 2.97; 0.69; -2.09; -3.71 | 0.0735 |
| SECONDARY Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26 |
0.61; 0.32; 3.68; 4.41; 3.47; 3.70 | 0.5673 |
| SECONDARY Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26 |
0.23; -0.32; -0.06; -0.06 | 0.5005 |
| SECONDARY Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26 |
-36.53; -35.63 | 0.1856 |
| SECONDARY Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26 |
-12.50; 4.46 | 0.1862 |
| SECONDARY Number of Subjects With Hypoglycemic Events |
70; 24; 69; 24; 0; 0 | — |
| SECONDARY Number of Total Hypoglycemic Events |
195; 41; 194; 41; 0; 0 | — |
| SECONDARY Number of Total Subject Months of Treatment |
145.8; 82.4; 145.8; 82.4; 145.8; 82.4 | — |
| SECONDARY Crude Hypoglycemic Event Rate |
1.3; 0.5; 1.3; 0.5; 0; 0 | — |
| SECONDARY Number of Nocturnal Hypoglycemic Events |
187; 114 | — |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
3.55; 2.33 | 0.0055 sig |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at Week 26 |
1.22; 0.80 | 0.0053 sig |
| SECONDARY Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire |
— | — |
Summary
This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.
Eligibility Criteria
Inclusion Criteria
- Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6 months prior to study entry
- Screening HbA1c > 7.0%
- Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione
Exclusion Criteria
Smoking within last 6 months PFTs outside of range
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
- Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.
Data sourced from ClinicalTrials.gov (NCT00418522). 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.