Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
NCT ID: NCT00147745
Last Updated: 2014-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2005-06-30
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
colesevelam 3.8g administered daily for 12 weeks
Colesevelam
Colesevelam 3.8g for 12 weeks
2
Colesevelam matching placebo for 12 weeks
Colesevelam matching placebo
Colesevelam matching placebo for 12 weeks
3
open-label Insulin Glargine for 12 weeks
Insulin glargine (Lantus)
Insulin glargine for 12 weeks
Interventions
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Colesevelam
Colesevelam 3.8g for 12 weeks
Colesevelam matching placebo
Colesevelam matching placebo for 12 weeks
Insulin glargine (Lantus)
Insulin glargine for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with type 2 diabetes
* Hemoglobin A1c value greater than or equal to 8.0%
* Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
* Overweight, obese (body mass index 25-45 kg/m2)
Exclusion Criteria
* Previous treatment with colesevelam for hyperlipidemia
* Serum triglyceride greater than 500 mg/dL
* Serum low density lipoprotein-cholesterol less than 60 mg/dL
18 Years
75 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Locations
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San Diego VMC
San Diego, California, United States
Countries
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Other Identifiers
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WEL-201
Identifier Type: -
Identifier Source: org_study_id
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