Clinical Trial Details
| Trial ID: | L4131 |
| Source ID: | NCT00993824 |
| Associated Drug: | Colesevelam Hcl |
| Title: | Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00993824/results |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: colesevelam HCl|DRUG: placebo |
| Outcome Measures: | Primary: Total Norm AUC Average by Group (Normalized), Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2., 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|Sleep Norm AUC Average by Group (Normalized), Overnight glucose captured by CGM., 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|Wake Norm AUC Average by Group (Normalized), Wake glucose captured by continuous glucose monitoring (CGM)., 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.|Hypoglycemia Percentage of Time <70 mg/dL Average by Group, Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM\<70 mg/dL), 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2. | |
| Sponsor/Collaborators: | Sponsor: HealthPartners Institute | Collaborators: International Diabetes Center at Park Nicollet|Daiichi Sankyo |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2|PHASE3 |
| Enrollment: | 21 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2009-09 |
| Completion Date: | 2011-09 |
| Results First Posted: | 2014-06-17 |
| Last Update Posted: | 2015-11-30 |
| Locations: | International Diabetes Center, Minneapolis, Minnesota, 55416, United States |
| URL: | https://clinicaltrials.gov/show/NCT00993824 |
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