Clinical Trial Details
| Trial ID: | L6632 |
| Source ID: | NCT01706211 |
| Associated Drug: | Brl 49653c |
| Title: | A Study to Evaluate the Efficacy and Safety of BRL 49653C in Non-insulin Dependent Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus Non Insulin Dependent Oral Agent Therapy |
| Interventions: | DRUG: BRL 49653C|DRUG: Placebo |
| Outcome Measures: | Primary: To determine the effectiveness of BRL 49653C (2 mg bd) compared to placebo when added to sulphonylurea therapy, for 24 weeks in out-patients with NIDDM., Primary: Change from baseline for Hb A1c at week 24. Secondary: Mean change from baseline for: fasting plasma glucose,insulin levels, immune reactive,lipid levels (ie.total cholesterol, HDL-cholesterol, LDL cholesterol, triglycerides), body weight (WHR), vital signs (systolic, diastolic blood pressure and heart rate), 7 months | Secondary: To assess the clinical safety of BRL 49653C (2 mg bd) compared to placebo when added to sulphonylurea therapy, for 24 weeks in out-patients with NIDOM., Physical examination, adverse experiences, laboratory safety data, ECG parameters, 7 months |
| Sponsor/Collaborators: | Sponsor: National Taiwan University Hospital |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 77 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 1998-10 |
| Completion Date: | 2000-04 |
| Results First Posted: | |
| Last Update Posted: | 2012-10-15 |
| Locations: | National Taiwan University Hospital, Taipei, 10002, Taiwan |
| URL: | https://clinicaltrials.gov/show/NCT01706211 |
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