| Trial ID: | L6165 |
| Source ID: | NCT01470937
|
| Associated Drug: |
Acarbose
|
| Title: |
Early Diabetes Intervention Program
|
| Acronym: |
EDIP
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Acarbose|DRUG: Placebo
|
| Outcome Measures: |
Primary: Progression of fasting glucose >140 mg/dL, Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression., From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization |
|
| Sponsor/Collaborators: |
Sponsor: Indiana University School of Medicine | Collaborators: Bayer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
219
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
1998-02
|
| Completion Date: |
2004-09
|
| Results First Posted: |
|
| Last Update Posted: |
2011-11-11
|
| Locations: |
Indiana University Hospital GCRC, Indianapolis, Indiana, 46202, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01470937
|
