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OpenTrials
Completed

NCT Number: NCT00356109

Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.

This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.

The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases 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., Buenos Aires, Argentina

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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 1 diabetes for at least 24 months
  • Have an HbA1c less than or equal to 11%
  • Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
  • Non-smoker

Exclusion criteria

  • Require a daily total insulin dosage greater than 150 U at screening
  • Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
  • Systemic glucocorticoid therapy
  • Clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • History of lung transplantation and/or lung cancer
  • Diagnosed with pneumonia in the 3 months prior to screening
  • History of renal transplantation
  • Active or untreated malignancy

Treatment and study plan

Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals, 6 months

Other names: LY041001

Injectable Insulin

Drug

patient specific dose, injected, before meals, 6 months

insulin glargine

Drug

patient specific dose, injectable, before meals, 6 months

Primary outcomes

  1. To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.

    Time frame: 6 months

Secondary outcomes

  1. Insulin dose requirements

    Time frame: throughout the study

  2. Insulin antibody binding levels

    Time frame: baseline, 1 month, 6 months, follow-up

  3. To compare HbAlc change

    Time frame: 6 months

  4. To assess rate and incidence of hypoglycemia

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study title

A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 25, 2006
Registry last updated
Mar 9, 2018

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

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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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