A Study for Patients With Type 2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Human Insulin Inhalation Powder; Drug: Neutral protamine hagedorn insulin

• Registration Number: NCT00490854
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-06-21
• Study First Submitted QC: 2007-06-21
• Study First Posted: 2007-06-25
• Study Start: 2007-07
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-03
• Last Update Posted: 2008-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

1. Type 2 diabetes mellitus for at least 6 months
2. One or more oral antihyperglycemic medications for at least 12 weeks
3. HbA1c equal to or greater than 7.0%, and equal to or less than 10.5%
4. 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
5. Satisfactory lung function results to meet the requirement of the study

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Exclusion Criteria

1. Previously received any form of inhaled insulin
2. Have a current diagnosis or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
3. History or presence of liver disease
4. History or presence of kidney disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Human Insulin Inhalation Powder	-
1	Neutral protamine hagedorn insulin	-
2	Human Insulin Inhalation Powder	-
2	Neutral protamine hagedorn insulin	-

Primary Outcome Measures

Name	Time	Method
Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase	24, 48 and 76 weeks after Randomization

Secondary Outcome Measures

Name	Time	Method
8-point SMBG profiles.	24, 48 and 76 weeks after Randomization
Mean change in HbA1c from baseline to the end.	24, 48 and 76 weeks after Randomization
Mean dosage of both preprandial and basal insulin.	24, 48 and 76 weeks after Randomization
Inhaler reliability.	24, 48 and 76 weeks after Randomization
Patient-reported outcomes questionnaires.	24, 48 and 76 weeks after Randomization

Trial Locations

Locations (1)

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.; 🇯🇵 Toyama, Japan