| Trial ID: | L6533 |
| Source ID: | NCT00375388
|
| Associated Drug: |
Metformin On Top Of Intensive Insulin Therapy
|
| Title: |
The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Metformin on top of intensive insulin therapy
|
| Outcome Measures: |
Primary: To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight). | Secondary: To investigate the occurrence and progression of macro- and microvascular complications.|To investigate the quality of life.|To perform a socio-economic evaluation.
|
| Sponsor/Collaborators: |
Sponsor: Bethesda General Hospital, Hoogeveen | Collaborators: Takeda|LifeScan|Merck KGaA, Darmstadt, Germany|Dupont Merck|Merck Sharp & Dohme LLC|Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
400
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
1998-01
|
| Completion Date: |
2002-10
|
| Results First Posted: |
|
| Last Update Posted: |
2006-09-13
|
| Locations: |
Bethesda General Hospital and Bethesda Diabetes Center, Hoogeveen, Drenthe, 7909 AA, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT00375388
|
