A Concordance Study Comparing Insulin Treatments in Patients With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Human Insulin Inhalation Powder; Drug: Insulin

• Registration Number: NCT00330473
• Lead Sponsor: Eli Lilly and Company

Brief Summary

A study to compare insulin use and its effect on glucose control and other outcomes in patients with Type 2 diabetes who together with their healthcare provider manage their disease by discussing and agreeing on the diabetes treatment chosen from a selection of available treatment options.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-26
• Study Start: 2006-06
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Disposition First Submitted: 2018-03-07
• Disposition First Submitted QC: 2018-03-07
• Disposition First Posted: 2018-03-09
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1019

Inclusion Criteria

• Type 2 Diabetes
• Insulin-naive
• Non-smoker

Exclusion Criteria

• Significant pulmonary, hepatic or renal disease
• severe congestive heart failure
• active malignancy or malignancy within the last 5 years
• systemic glucocorticoid therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Human Insulin Inhalation Powder	Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.
2	Insulin	Treatment Options available on the market.

Primary Outcome Measures

Name	Time	Method
To assess blood sugar control as measured by HbA1c	baseline, 1,3,5,7,9 months
To assess acceptance of insulin therapy	9 months

Secondary Outcome Measures

Name	Time	Method
To measure changes in HbA1c over time	baseline, 1,3,5,7,9 months
To assess safety by review of adverse events	throughout study
To assess patient-reported outcomes based on the W-BQ12 questionnaire	screening, baseline, months 5, and 9
To assess patient-reported outcomes based on the DTSQ Questionnaire	Screening,baseline, months 5 and 9
To assess patient-reported outcomes based on the DSC-R questionnaire	screening,baseline, months 5 and 9

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.; 🇿🇦 Pretoria, South Africa