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The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colesevelam hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the fasting plasma glucose and fructosamine lowering effect; | ||
| To assess the glycemic control response rate; | ||
| To assess the improvement in insulin sensitivity; |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRO | Jonesboro | Arkansas | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18852398 | Derived | Bays HE, Goldberg RB, Truitt KE, Jones MR. Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: glucose and lipid effects. Arch Intern Med. 2008 Oct 13;168(18):1975-83. doi: 10.1001/archinte.168.18.1975. |
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| To assess the effect on high sensitivity C-reactive protein; |
| To assess the improvement in lipids, and lipoproteins; |
| To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy |
| Beverly Hills |
| California |
| United States |
| Carmichael | California | United States |
| Fresno | California | United States |
| Irvine | California | United States |
| La Jolla | California | United States |
| Los Gatos | California | United States |
| San Diego | California | United States |
| Spring Valley | California | United States |
| West Hills | California | United States |
| Washington D.C. | District of Columbia | United States |
| Coco Beach | Florida | United States |
| Largo | Florida | United States |
| Miami | Florida | United States |
| Pembroke Pines | Florida | United States |
| West Palm Beach | Florida | United States |
| Atlanta | Georgia | United States |
| Evansville | Indiana | United States |
| Louisville | Kentucky | United States |
| Detroit | Michigan | United States |
| Troy | Michigan | United States |
| Edina | Minnesota | United States |
| Chesterfield | Missouri | United States |
| Bozeman | Montana | United States |
| Butte | Montana | United States |
| Las Vegas | Nevada | United States |
| Rochester | New York | United States |
| Charlotte | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Lyndhurst | Ohio | United States |
| Marion | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Tulsa | Oklahoma | United States |
| Portland | Oregon | United States |
| Beaver | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Columbia | South Carolina | United States |
| Morristown | Tennessee | United States |
| Corpus Christi | Texas | United States |
| Dallas | Texas | United States |
| Pharr | Texas | United States |
| San Antonio | Texas | United States |
| Arlington | Virginia | United States |
| Richmond | Virginia | United States |
| Mexico City | Mexico |
| Lima | Peru |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069472 | Colesevelam Hydrochloride |
| ID | Term |
|---|---|
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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