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OpenTrials
Completed

NCT Number: NCT00355849

Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder [also known as AIR® Inhaled Insulin][AIR® is a registered trademark of Alkermes,Inc.] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.

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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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Curitiba, Brazil

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetes mellitus
  • one or more oral antihyperglycemic medications
  • once-daily insulin glargine
  • HbA1c greater than or equal to 7.5 and less than or equal to 10.5%
  • Non-smoker

Exclusion criteria

  • taking a TZD dose greater than what is indicated
  • more than two episodes of severe hypoglycemia during the 6 months prior
  • Have had a lower respiratory infection in the 3 months prior
  • systemic glucocorticoid therapy
  • clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • history of renal transplantation
  • Have an active or untreated malignancy
  • Require more than 150 U/day of insulin glargine

Treatment and study plan

Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals, 52 weeks

Other names: LY041001

insulin glargine

Drug

patient specific dose, injectable, before meals, 52 weeks

Primary outcomes

  1. To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.

    Time frame: 24 weeks

Secondary outcomes

  1. To measure changes in HbA1c over time

    Time frame: 24 weeks

  2. To assess insulin dose requirements

    Time frame: 24 and 52 weeks

  3. To assess rate and incidence of hypoglycemia

    Time frame: 24 and 52 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study title

A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 25, 2006
Registry last updated
Sep 16, 2019

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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