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This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00418522
Recruitment Status : Completed
First Posted : January 5, 2007
Results First Posted : September 4, 2009
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

January 3, 2007
January 5, 2007
July 30, 2009
September 4, 2009
September 28, 2018
March 2007
August 2008   (Final data collection date for primary outcome measure)
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population [ Time Frame: Baseline, Week 26 ]
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Demonstrate non-inferiority of dry powder inhaled insulin (EXUBERA) compared to insulin glargine (LANTUS) in terms of glycemic control (HbA1c) after 26 weeks of treatment
Complete list of historical versions of study NCT00418522 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26 [ Time Frame: Week 26 ]
    Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26 [ Time Frame: Week 26 ]
    Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26 [ Time Frame: Week 26 ]
    Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.
  • Change From Baseline in Fasting Plasma Glucose at Week 26 [ Time Frame: Baseline, Week 26 ]
    Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.
  • Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26 [ Time Frame: Baseline, Week 26 ]
    Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.
  • Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26 [ Time Frame: Baseline, Week 26 ]
    Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.
  • Change From Baseline in Lipids at Week 26 [ Time Frame: Baseline, Week 26 ]
    Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.
  • Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26 [ Time Frame: Baseline, Week 26 ]
    CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.
  • Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26 [ Time Frame: Baseline, Week 26 ]
    CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.
  • Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26 [ Time Frame: Baseline, Week 26 ]
    24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.
  • Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26 [ Time Frame: Baseline, Week 26 ]
    SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.
  • Number of Subjects With Hypoglycemic Events [ Time Frame: Months 1 to 7 ]
    A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
  • Number of Total Hypoglycemic Events [ Time Frame: Months 1 to 7 ]
    A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.
  • Number of Total Subject Months of Treatment [ Time Frame: Months 1 to 7 ]
    Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
  • Crude Hypoglycemic Event Rate [ Time Frame: Months 1 to 7 ]
    crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
  • Number of Nocturnal Hypoglycemic Events [ Time Frame: Months 1 to 7 ]
    A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.
  • Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline, Week 26 ]
    Body weight value: Change = value at Week 26 minus value at Baseline.
  • Change From Baseline in Body Mass Index (BMI) at Week 26 [ Time Frame: Baseline, Week 26 ]
    BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.
  • 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 [ Time Frame: Baseline, Week 26 ]
    Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed.
  • Secondary endpoints include the following at week 26:
  • Proportion of patients achieving HbA1c < 6.5%
  • Proportion of patients achieving HbA1c < 7.0
  • Proportion of patients achieving HbA1c < 8.0%
  • Change from baseline in fasting plasma glucose level
  • Change from baseline in postprandial blood glucose excursions as measured by 8-point profiles and as determined by standardized meal tolerance tests
  • Change from baseline in fasting and postprandial plasma glucose, lipids (such as total cholesterol, HDL-c, LDL-c, triglycerides) and CV biomarkers (such as hs-CRP, leptin, adiponectin and apoB and spot urine microalbumin)
  • Change from baseline in 24-hour mean glucose values, and glycemic variability measured by CGMS
  • Incidence and severity of hypoglycemia
  • Incidence and severity of nocturnal hypoglycemia
  • Change from baseline in body weight and body mass index (BMI)
  • Proportion of patients who discontinue due to insufficient clinical response
  • Incidence of clinical adverse events
  • Change from baseline in treatment satisfaction, diabetes related quality of life, mental health and energy/vitality
  • Characterization of a 24-hour glucose profile in a subset of patient
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS [ Time Frame: Baseline, Week 26 ]
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Not Provided
 
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
A Six Month, Open Label, 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
This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Insulin glargine
    Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
  • Drug: Inhaled Insulin (Exubera)
    Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
  • Active Comparator: Insulin glargine
    Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
    Intervention: Drug: Insulin glargine
  • Experimental: Exubera
    Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
    Intervention: Drug: Inhaled Insulin (Exubera)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
413
478
August 2008
August 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00418522
A2171095
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP