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Completed

NCT Number: NCT00134147

A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diabetes mellitus Type 2
  • Failing two or more oral anti-diabetic agents

Exclusion criteria

  • Asthma, COPD
  • Smoking

Treatment and study plan

Inhaled Insulin

Drug

Primary outcomes

  1. Glycosylated hemoglobin

Secondary outcomes

  1. Percent of patients achieving good control of fasting glucose and lipids

  2. Rate of hypoglycemia

  3. Changes in body weight

  4. Patient satisfaction

  5. Safety based on adverse events reported and laboratory tests

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Sanofi

Registry information

Official study title

A One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera) on Glycemic Control in Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents

Important dates

Study start
2005
Study completion
2007
First posted
Aug 24, 2005
Registry last updated
Apr 17, 2008

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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