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OpenTrials
Completed

NCT Number: NCT00418522

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Carolina, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glargine

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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%.

  2. 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%.

  3. 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%.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 5, 2007
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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