Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Nektar Therapeutics
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00370565
First received: August 29, 2006
Last updated: February 9, 2007
Last verified: February 2007
  Purpose

To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Inhaled Human Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
  • HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.

Secondary Outcome Measures:
  • Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
  • Meal glucose response measured at Week -1 and at Week 12;
  • These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
  • not the subject’s home glucose monitoring results.
  • Comparison of 24-hour home glucose profiles.
  • Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.
  • A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.

Estimated Enrollment: 345
Study Start Date: June 1999
Estimated Study Completion Date: September 2000
  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
  • Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).

Exclusion Criteria:

  • Asthma, COPD
  • Smoking during the previous 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370565

  Show 52 Study Locations
Sponsors and Collaborators
Pfizer
Sanofi
Nektar Therapeutics
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00370565     History of Changes
Other Study ID Numbers: 217-109
Study First Received: August 29, 2006
Last Updated: February 9, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014