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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391027
• Other study ID #: A2171084
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2006
• Last updated: June 30, 2015
• Start date: December 2006
• Est. completion date: August 2008

Study information

• Verified date: June 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Diabetes Mellitus, Type 2 on oral agents

• Age > 30 years

Exclusion Criteria:

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease

• Smoking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine (Lantus®)
Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
• Inhaled Human Insulin (Exubera®)
Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bornem
Belgium	Pfizer Investigational Site	Brussels
Belgium	Pfizer Investigational Site	Genk
Belgium	Pfizer Investigational Site	Liège 1
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Lahti
Finland	Pfizer Investigational Site	Oulu
France	Pfizer Investigational Site	Besancon
France	Pfizer Investigational Site	Corbeil Essonnes Cedex
France	Pfizer Investigational Site	LA Rochelle CEDEX
France	Pfizer Investigational Site	Marseille Cedex 5
France	Pfizer Investigational Site	Paris Cedex 10
France	Pfizer Investigational Site	Valenciennes Cedex 1
Germany	Pfizer Investigational Site	Altenburg
Germany	Pfizer Investigational Site	Eisenach
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hohenmoelsen
Germany	Pfizer Investigational Site	Leipzig
Germany	Pfizer Investigational Site	Neuss
Germany	Pfizer Investigational Site	Riesa
Germany	Pfizer Investigational Site	Wangen / Allgaeu
Netherlands	Pfizer Investigational Site	Den Bosch
Netherlands	Pfizer Investigational Site	Den Haag
Netherlands	Pfizer Investigational Site	Eindhoven
Netherlands	Pfizer Investigational Site	Nijmegen
Netherlands	Pfizer Investigational Site	Venlo
Norway	Pfizer Investigational Site	Bergen
Norway	Pfizer Investigational Site	Honefoss	Buskerud
Norway	Pfizer Investigational Site	Jessheim
Norway	Pfizer Investigational Site	Lysaker
Norway	Pfizer Investigational Site	Skedsmokorset
Poland	Pfizer Investigational Site	Lask
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Lublin
Poland	Pfizer Investigational Site	Warszawa
Spain	Pfizer Investigational Site	A Coruña
Spain	Pfizer Investigational Site	Alzira	Valencia
Spain	Pfizer Investigational Site	Huelva
Spain	Pfizer Investigational Site	Inca	Mallorca
Spain	Pfizer Investigational Site	La Laguna	Santa Cruz de Tenerife
Spain	Pfizer Investigational Site	Malaga
Spain	Pfizer Investigational Site	Palma de Mallorca	Islas Baleares
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Boras
Sweden	Pfizer Investigational Site	Eksjo
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Harnosand
Sweden	Pfizer Investigational Site	Helsingborg
Sweden	Pfizer Investigational Site	Järfälla
Sweden	Pfizer Investigational Site	Kristianstad
Sweden	Pfizer Investigational Site	Linkoping
Sweden	Pfizer Investigational Site	Lulea
Sweden	Pfizer Investigational Site	Malmo
Sweden	Pfizer Investigational Site	Motala
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Uddevalla
Sweden	Pfizer Investigational Site	Umea
Sweden	Pfizer Investigational Site	Vaxjo
Switzerland	Pfizer Investigational Site	Bruderholz
Switzerland	Pfizer Investigational Site	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 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.	Baseline, Week 26	No
Secondary	Change From Baseline in HbA1c Prior to Week 26	Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.	Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18	No
Secondary	Number of Subjects With HbA1c < 6.5 %	Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.	Week 26	No
Secondary	Number of Subjects With HbA1c < 7.0 %	Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.	Week 26	No
Secondary	Number of Subjects With HbA1c < 8.0 %	Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.	Week 26	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) Level	FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.	Baseline, Week 26	No
Secondary	Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)	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.	Baseline, Week 26	No
Secondary	Number of Subjects With Hypoglycemic Events by Severity	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.	Week 26	No
Secondary	Number of Events of Nocturnal Hypoglycemia	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.	Week 26	No
Secondary	Change From Baseline in Body Weight	Change from baseline calculated as body weight at observation minus body weight at baseline.	Baseline, Week 26	No
Secondary	Change From Baseline in Body Mass Index (BMI)	BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.	Baseline, Week 26	No
Secondary	Number of Subjects Discontinued Due to Insufficient Clinical Response	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.	Week 26	No
Secondary	Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health	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.	Week 26	No
Secondary	Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients	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.	Baseline, Week 26	No
Secondary	Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)	Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.	Baseline, Week 26	No
Secondary	Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)	Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.	Baseline, Week 26	No
Secondary	Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)	Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.	Baseline, Week 26	No
Secondary	Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)	Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.	Baseline, Week 26	No
Secondary	Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (a) in a Subset of Subjects	Urinary free 8-iso prostaglandin F2-alpha (a): 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.	Baseline, Week 26	No

External Links

•   To obtain contact information for a study center near you, click here.