| Trial ID: | L7206 |
| Source ID: | NCT00449553
|
| Associated Drug: |
Pioglitazone And Sulphonylurea
|
| Title: |
Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: Pioglitazone and sulphonylurea|DRUG: Pioglitazone and sulphonylurea|DRUG: Pioglitazone and metformin|DRUG: Pioglitazone and metformin
|
| Outcome Measures: |
Primary: Change from baseline in glycosylated hemoglobin., 6 months | Secondary: Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin)., End of Treatment|Change from baseline in Body Weight., End of Treatment|Percentage of treatment responders defined as a patient with 0.6% decrease in HbA1C from baseline visit to final visit or accomplishment of a HbA1c value at or below 6.5%., End of Treatment|Change from baseline in beta-cell function (Homeostasis model assessment)., End of Treatment|Change from baseline in insulin resistance (Homeostasis model assessment)., End of Treatment|Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides)., End of Treatment
|
| Sponsor/Collaborators: |
Sponsor: Takeda | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
326
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2001-06
|
| Completion Date: |
2003-09
|
| Results First Posted: |
|
| Last Update Posted: |
2012-02-28
|
| Locations: |
Multiple, Denmark|Multiple, Iceland|Multiple, Norway|Multiple, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT00449553
|
