A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
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|ClinicalTrials.gov Identifier: NCT00391027|
Recruitment Status : Completed
First Posted : October 23, 2006
Results First Posted : October 21, 2009
Last Update Posted : July 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Insulin Glargine (Lantus®) Drug: Inhaled Human Insulin (Exubera®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||261 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
|Active Comparator: Insulin Glargine (Lantus®)||
Drug: Insulin Glargine (Lantus®)
Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
|Active Comparator: Inhaled Human Insulin (Exubera®)||
Drug: Inhaled Human Insulin (Exubera®)
Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 [ Time Frame: Baseline, Week 26 ]Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.
- Change From Baseline in HbA1c Prior to Week 26 [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18 ]Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.
- Number of Subjects With HbA1c < 6.5 % [ Time Frame: Week 26 ]Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.
- Number of Subjects With HbA1c < 7.0 % [ Time Frame: Week 26 ]Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.
- Number of Subjects With HbA1c < 8.0 % [ Time Frame: Week 26 ]Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.
- Change From Baseline in Fasting Plasma Glucose (FPG) Level [ Time Frame: Baseline, Week 26 ]FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.
- Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point) [ Time Frame: Baseline, Week 26 ]Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.
- Number of Subjects With Hypoglycemic Events by Severity [ Time Frame: Week 26 ]Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.
- Number of Events of Nocturnal Hypoglycemia [ Time Frame: Week 26 ]Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.
- Change From Baseline in Body Weight [ Time Frame: Baseline, Week 26 ]Change from baseline calculated as body weight at observation minus body weight at baseline.
- Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 26 ]BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.
- Number of Subjects Discontinued Due to Insufficient Clinical Response [ Time Frame: Week 26 ]Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12.
- Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health [ Time Frame: Week 26 ]Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program.
- Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients [ Time Frame: Baseline, Week 26 ]The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.
- Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP) [ Time Frame: Baseline, Week 26 ]Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.
- Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6) [ Time Frame: Baseline, Week 26 ]Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.
- Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes) [ Time Frame: Baseline, Week 26 ]Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.
- Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF) [ Time Frame: Baseline, Week 26 ]Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.
- Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects [ Time Frame: Baseline, Week 26 ]Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391027
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|