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

Phase 4CompletedNCT00391027

Pfizer261 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

261

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine (Lantus®)DRUG

Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.

Inhaled Human Insulin (Exubera®)DRUG

Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetes Mellitus, Type 2 on oral agents * Age \> 30 years Exclusion Criteria: * Severe Asthma, severe Chronic Obstructive Pulmonary Disease * Smoking

Locations (62)

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 26

Secondary Outcomes

Change From Baseline in HbA1c Prior to Week 26

Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.

Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18

Number of Subjects With HbA1c < 6.5 %

Number of subjects with glycemic control HbA1c measurement of \< 6.5 % at observation.

Time frame: Week 26

Number of Subjects With HbA1c < 7.0 %

Number of subjects with glycemic control HbA1c measurement of \< 7.0 % at observation.

Time frame: Week 26

Number of Subjects With HbA1c < 8.0 %

Number of subjects with glycemic control HbA1c measurement of \< 8.0 % at observation.

Time frame: Week 26

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.

Time frame: Baseline, Week 26

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.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Bornem, Belgium

Pfizer Investigational Site

Brussels, Belgium

Pfizer Investigational Site

Genk, Belgium

Pfizer Investigational Site

Liège, Belgium

Pfizer Investigational Site

Kuopio, Finland

Pfizer Investigational Site

Lahti, Finland

Pfizer Investigational Site

Oulu, Finland

Pfizer Investigational Site

Besançon, France

Pfizer Investigational Site

Corbeil-Essonnes, France

Pfizer Investigational Site

La Rochelle, France

...and 52 more locations

Time frame: Baseline, Week 26

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.

Time frame: Week 26

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.

Time frame: Week 26

Change From Baseline in Body Weight

Change from baseline calculated as body weight at observation minus body weight at baseline.

Time frame: Baseline, Week 26

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.

Time frame: Baseline, Week 26

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.

Time frame: Week 26

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.

Time frame: Week 26

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.

Time frame: Baseline, Week 26

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.

Time frame: Baseline, Week 26

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.

Time frame: Baseline, Week 26

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.

Time frame: Baseline, Week 26

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.

Time frame: Baseline, Week 26

Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects

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.

Time frame: Baseline, Week 26