A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Glargine (Lantus®); Drug: Inhaled Human Insulin (Exubera®)

• Registration Number: NCT00391027
• Lead Sponsor: Pfizer

Brief Summary

To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-10-19
• Study First Submitted QC: 2006-10-19
• Study First Posted: 2006-10-23
• Study Start: 2006-12
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-08-05
• Results First Submitted QC: 2009-09-15
• Results First Posted: 2009-10-21
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• Diabetes Mellitus, Type 2 on oral agents
• Age > 30 years

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Exclusion Criteria

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease
• Smoking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Glargine (Lantus®)	Insulin Glargine (Lantus®)	-
Inhaled Human Insulin (Exubera®)	Inhaled Human Insulin (Exubera®)	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Mass Index (BMI)	Baseline, Week 26	BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.
Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)	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	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	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	Baseline, Week 26	Change from baseline calculated as body weight at observation minus body weight at baseline.
Number of Subjects Discontinued Due to Insufficient Clinical Response	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	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	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)	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)	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)	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)	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	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.
Change From Baseline in HbA1c Prior to Week 26	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 %	Week 26	Number of subjects with glycemic control HbA1c measurement of \< 6.5 % at observation.
Number of Subjects With HbA1c < 7.0 %	Week 26	Number of subjects with glycemic control HbA1c measurement of \< 7.0 % at observation.
Number of Subjects With HbA1c < 8.0 %	Week 26	Number of subjects with glycemic control HbA1c measurement of \< 8.0 % at observation.
Change From Baseline in Fasting Plasma Glucose (FPG) Level	Baseline, Week 26	FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇭 St. Gallen, Switzerland