NCT00330473CompletedPhase 3
A Phase 3, Open-Label, Parallel Group Treatment Concordance Study to Compare Insulin Use and Its Effect on Glycemic Control in Patients With Type 2 Diabetes Mellitus: Two Populations With Different Insulin Treatment Options
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,019
- Locations
- 1
- Primary Endpoint
- To assess blood sugar control as measured by HbA1c
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Treatment options available on the market plus the option of taking Human Insulin Inhalation Powder.
Intervention: Human Insulin Inhalation Powder (Drug)
2
Active Comparator
Treatment Options available on the market.
Intervention: Insulin (Drug)
Outcomes
Primary Outcomes
To assess blood sugar control as measured by HbA1c
Time Frame: baseline, 1,3,5,7,9 months
To assess acceptance of insulin therapy
Time Frame: 9 months
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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