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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Inhaled Insulin (Exubera); Drug: Insulin glargine

• Registration Number: NCT00418522
• Lead Sponsor: Pfizer

Brief Summary

This study is to determine if inhaled insulin is effective in treating 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: 2007-01-03
• Study First Submitted QC: 2007-01-04
• Study First Posted: 2007-01-05
• Study Start: 2007-03
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-07-30
• Results First Submitted QC: 2009-07-30
• Results First Posted: 2009-09-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exubera	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.
Insulin glargine	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population	Baseline, Week 26	HbA1c lab value: Change = value at Week 26 minus value at Baseline.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇷 Carolina, Puerto Rico