Clinical Trial Details
| Trial ID: | L5695 |
| Source ID: | NCT00515632 |
| Associated Drug: | Balaglitazone |
| Title: | Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy |
| Acronym: | BALLET |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Balaglitazone |
| Outcome Measures: | Primary: HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters., baseline, 4, 8, 12, 17, 21 and 26 weeks | Secondary: Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin, baseline and 26 weeks |
| Sponsor/Collaborators: | Sponsor: Rheoscience A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 409 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2007-07 |
| Completion Date: | 2009-10 |
| Results First Posted: | |
| Last Update Posted: | 2010-07-23 |
| Locations: | Multi-center, Copenhagen, Denmark |
| URL: | https://clinicaltrials.gov/show/NCT00515632 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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