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Completed

NCT Number: NCT00325364

Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

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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., Fortaleza, 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
  • Non smoker
  • Normal lung function

Exclusion criteria

  • Pulmonary, hepatic, or renal disease
  • Congestive heart failure
  • Active malignancy
  • Systemic glucocorticoid therapy

Treatment and study plan

Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals, 24 months

Other names: LY041001

Injectable Insulin

Drug

patient specific dose, injectable, before meals, 24 months

Primary outcomes

  1. To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin

    Time frame: 6 months

Secondary outcomes

  1. To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin

    Time frame: 24 months

  2. To compare inhaled human insulin to injectable insulin over time with respect to change on body weight

    Time frame: baseline and every visit

  3. To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction

    Time frame: baseline, 6 months, 12 months, 18 months, 24 months

  4. To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c

    Time frame: baseline and every visit

  5. To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia

    Time frame: throughout the study

  6. To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements

    Time frame: 24 months

  7. To test dose titration methods

    Time frame: 6 months

  8. To assess inhaler reliability

    Time frame: throughout the study

  9. To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients

    Time frame: 3 months, 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 and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 12, 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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