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Completed

NCT Number: NCT00490854

A Study for Patients With Type 2 Diabetes Mellitus

The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.

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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

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., Aichi, 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 2 diabetes mellitus for at least 6 months
  • One or more oral antihyperglycemic medications for at least 12 weeks
  • HbA1c equal to or greater than 7.0%, and equal to or less than 10.5%
  • Nonsmokers, have 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
  • Have a current diagnosis 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

Human Insulin Inhalation Powder

Drug

patient specific, inhaled, at meals, 76 weeks

Other names: LY 041001

Neutral protamine hagedorn insulin

Drug

patient specific dose, injected, daily, 76 weeks

Primary outcomes

  1. Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase

    Time frame: 24, 48 and 76 weeks after Randomization

Secondary outcomes

  1. 8-point SMBG profiles.

    Time frame: 24, 48 and 76 weeks after Randomization

  2. Mean change in HbA1c from baseline to the end.

    Time frame: 24, 48 and 76 weeks after Randomization

  3. Mean dosage of both preprandial and basal insulin.

    Time frame: 24, 48 and 76 weeks after Randomization

  4. Inhaler reliability.

    Time frame: 24, 48 and 76 weeks after Randomization

  5. Patient-reported outcomes questionnaires.

    Time frame: 24, 48 and 76 weeks after Randomization

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 Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 25, 2007
Registry last updated
Jul 10, 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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