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Completed

NCT Number: NCT00447213

A Study for Patients With Type 1 Diabetes Mellitus

The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.

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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

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / 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., Kanagawa, Japan

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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 mellitus for at least 24 months
  • Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
  • HbA1c equal or less than 11 %
  • Nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study
  • Satisfactory lung function results to meet the requirement of the study

Exclusion criteria

  • Previously received any form of inhaled insulin
  • Require a daily total insulin dosage greater than 100 U
  • Have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
  • History or presence of liver disease
  • History or presence of kidney disease

Treatment and study plan

insulin glargine

Drug

Patient specific, injected, daily, 24 weeks

Human Insulin Inhalation Powder

Drug

patient specific dose, inhaled, before meals,12 weeks

Other names: LY041001

Injectable Insulin

Drug

Patient specific dose,injected, before meals, 12 weeks

Primary outcomes

  1. Change in HbA1c from baseline

    Time frame: 12 and 24 weeks

Secondary outcomes

  1. Proportion of patients who achieve an HbA1c < 7% and <= 6.5%

    Time frame: 12 and 24 weeks

  2. Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses

    Time frame: at each visit

  3. 8-point self monitoring blood glucose profiles

    Time frame: 12 and 24 weeks

  4. Two hour glucose excursions for the morning, midday, and evening meals

    Time frame: 12 and 24 weeks

  5. Inhaler reliability

    Time frame: throughout the study

  6. Patient-reported treatment satisfaction and insulin delivery satisfaction

    Time frame: 12 and 24 weeks

  7. Preference for the study therapies

    Time frame: week 24

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study title

A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 14, 2007
Registry last updated
Oct 13, 2010

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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