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

Phase 4CompletedNCT00418522

Pfizer413 enrolled

Overview

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

413

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin glargineDRUG

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.

Inhaled Insulin (Exubera)DRUG

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (73)

Outcomes

Primary Outcomes

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population

HbA1c lab value: Change = value at Week 26 minus value at Baseline.

Time frame: Baseline, Week 26

Secondary Outcomes

Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26

Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.

Time frame: Week 26

Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26

Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.

Time frame: Week 26

Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26

Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.

Time frame: Week 26

Change From Baseline in Fasting Plasma Glucose at Week 26

Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.

Time frame: Baseline, Week 26

Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at 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.

Time frame: Baseline, Week 26

Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at 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.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Phoenix, Arizona, United States

Pfizer Investigational Site

Tucson, Arizona, United States

Pfizer Investigational Site

Concord, California, United States

Pfizer Investigational Site

Encino, California, United States

Pfizer Investigational Site

Fresno, California, United States

Pfizer Investigational Site

Fullerton, California, United States

Pfizer Investigational Site

Long Beach, California, United States

Pfizer Investigational Site

Mission Viejo, California, United States

Pfizer Investigational Site

Pasadena, California, United States

Pfizer Investigational Site

San Diego, California, United States

...and 63 more locations

Time frame: Baseline, Week 26

Change From Baseline in Lipids at 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.

Time frame: Baseline, Week 26

Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26

CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.

Time frame: Baseline, Week 26

Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26

CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.

Time frame: Baseline, Week 26

Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at 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.

Time frame: Baseline, Week 26

Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at 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.

Time frame: Baseline, Week 26

Number of Subjects With Hypoglycemic Events

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.

Time frame: Months 1 to 7

Number of Total Hypoglycemic Events

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.

Time frame: Months 1 to 7

Number of Total Subject Months of Treatment

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.

Time frame: Months 1 to 7

Crude Hypoglycemic Event Rate

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.

Time frame: Months 1 to 7

Number of Nocturnal Hypoglycemic Events

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.

Time frame: Months 1 to 7

Change From Baseline in Body Weight at Week 26

Body weight value: Change = value at Week 26 minus value at Baseline.

Time frame: Baseline, Week 26

Change From Baseline in Body Mass Index (BMI) at Week 26

BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.

Time frame: Baseline, Week 26

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

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.

Time frame: Baseline, Week 26