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The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Welchol | Experimental | Welchol 625mg tablets |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Welchol | Drug | Welchol 625mg tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Hemoglobin A1c | change in HbA1c from baseline to Week 24 | 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose | to determine changes in Glycemic control after 24 weeks on therapy | from baseline to 24 weeks |
| % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units | to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35216 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24356792 | Derived | Rosenstock J, Rigby SP, Ford DM, Tao B, Chou HS. The glucose and lipid effects of colesevelam as monotherapy in drug-naive type 2 diabetes. Horm Metab Res. 2014 May;46(5):348-53. doi: 10.1055/s-0033-1358759. Epub 2013 Dec 19. |
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There was a 2-week placebo lead-in prior to randomization to treatment arm. Participants were excluded if two or more fasting blood glucose readings >240 mg/dL occurred during lead-in.
Subjects were excluded if there had been oral antidiabetic, significant insulin, or bile acid sequestrant therapy in the 3 months prior to screening.
From January 2009 through July 2011, subjects were recruited from medical clinics, private practice and research clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Welchol | Welchol 625mg tablets Welchol : Welchol 625mg tablets |
| FG001 | Placebo | placebo Placebo : placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
placebo |
|
| 24 weeks |
| % Subjects Achieving an HbA1C Goal of <7.0 | % Subjects achieving an HbA1C goal of <7.0 at 24 weeks | 24 weeks |
| % Subjects With a Decrease in FPG >=30 mg/dL | % Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks | from baseline to 24 weeks |
| Changes in Total Cholesterol [TC] | To assess the effects of Welchol on changes in total cholesterol [TC] | from baseline to 24 weeks |
| Changes in Low Density Lipoprotein Cholesterol [LDL-C] | To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C] | from baseline to 24 weeks |
| Changes in High Density Lipoprotein Cholesterol [HDL-C] | To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C] | from baseline to 24 weeks |
| Changes in Non-HDL-C | To assess the effects of Welchol on changes in non-HDL-C | from baseline to 24 weeks |
| Changes in Triglycerides [TG] | To assess the effects of Welchol on changes in triglycerides [TG] | from baseline to 24 weeks |
| Changes in Apolipoprotein A-I (apoA-I) | To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I) | from baseline to 24 weeks |
| Changes in Apolipoprotein B (apoB) | To assess the effects of Welchol on changes in apolipoprotein B (apoB) | from baseline to 24 weeks |
| Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test | To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test | from baseline to 24 weeks |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Montgomery | Alabama | 36117 | United States |
| Muscle Shoals | Alabama | 35662 | United States |
| Green Valley | Arizona | 85614 | United States |
| Mesa | Arizona | 85203 | United States |
| Mesa | Arizona | 85210 | United States |
| Tucson | Arizona | 85705 | United States |
| Tucson | Arizona | 85723 | United States |
| Tucson | Arizona | 85741 | United States |
| Searcy | Arkansas | 72143 | United States |
| Buena Park | California | 90620 | United States |
| Burbank | California | 91505 | United States |
| Chula Vista | California | 91910 | United States |
| Garden Grove | California | 92844 | United States |
| Huntington Park | California | 90255 | United States |
| Irvine | California | 92618 | United States |
| La Mirada | California | 90638 | United States |
| Lincoln | California | 95648 | United States |
| Lomita | California | 90717 | United States |
| Los Angeles | California | 90015 | United States |
| Los Angeles | California | 90057 | United States |
| Los Gatos | California | 95032 | United States |
| Santa Ana | California | 92701 | United States |
| Tustin | California | 92780 | United States |
| Walnut Creek | California | 94598 | United States |
| Brooksville | Florida | 34601 | United States |
| Coral Gables | Florida | 33134 | United States |
| DeLand | Florida | 32720 | United States |
| Delray Beach | Florida | 33484 | United States |
| Gulf Breeze | Florida | 32561 | United States |
| Hialeah | Florida | 33012 | United States |
| Jacksonville | Florida | 32223 | United States |
| Kissimmee | Florida | 34741 | United States |
| Miami | Florida | 33135 | United States |
| Miami | Florida | 33169 | United States |
| Miami | Florida | 33175 | United States |
| New Port Richey | Florida | 34652 | United States |
| Ocala | Florida | 34471 | United States |
| Ormond Beach | Florida | 32174 | United States |
| Pembroke Pines | Florida | 33026 | United States |
| Vero Beach | Florida | 32960 | United States |
| Wellington | Florida | 33449 | United States |
| Winter Park | Florida | 32789 | United States |
| Decatur | Georgia | 30035 | United States |
| East Point | Georgia | 30344 | United States |
| Roswell | Georgia | 30076 | United States |
| Stockbridge | Georgia | 30281 | United States |
| Stone Mountain | Georgia | 30083 | United States |
| Nampa | Idaho | 83686 | United States |
| Chicago | Illinois | 60607 | United States |
| Evansville | Indiana | 47714 | United States |
| La Porte | Indiana | 46350 | United States |
| South Bend | Indiana | 46614 | United States |
| Crestview Hills | Kentucky | 41017 | United States |
| Lafayette | Louisiana | 70503 | United States |
| Prince Frederick | Maryland | 20678 | United States |
| Silver Spring | Maryland | 20910 | United States |
| New Bedford | Massachusetts | 02740 | United States |
| Southfield | Michigan | 48034 | United States |
| Port Gibson | Mississippi | 39150 | United States |
| St Louis | Missouri | 63128 | United States |
| St Louis | Missouri | 63141 | United States |
| Billings | Montana | 59101 | United States |
| Las Vegas | Nevada | 89123 | United States |
| Berlin | New Jersey | 08009 | United States |
| Clifton | New Jersey | 07013 | United States |
| Mine Hill | New Jersey | 07803 | United States |
| New Windsor | New York | 12553 | United States |
| North Massapequa | New York | 11758-1802 | United States |
| West Seneca | New York | 14224 | United States |
| Lexington | North Carolina | 27295 | United States |
| Statesville | North Carolina | 28625 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cincinnati | Ohio | 45227 | United States |
| Cincinnati | Ohio | 45245 | United States |
| Cleveland | Ohio | 44122 | United States |
| Cuyahoga Falls | Ohio | 44223 | United States |
| Marion | Ohio | 43302 | United States |
| Munroe Falls | Ohio | 44262 | United States |
| Shaker Heights | Ohio | 44120 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Oklahoma City | Oklahoma | 73159 | United States |
| Portland | Oregon | 97220 | United States |
| Harrisburg | Pennsylvania | 17112 | United States |
| Jersey Shore | Pennsylvania | 17740 | United States |
| Charleston | South Carolina | 29412 | United States |
| Charleston | South Carolina | 29414 | United States |
| Columbia | South Carolina | 29201 | United States |
| Greer | South Carolina | 29651 | United States |
| Arlington | Texas | 76012 | United States |
| Dallas | Texas | 75230 | United States |
| Dallas | Texas | 75235 | United States |
| Fort Worth | Texas | 76117 | United States |
| Houston | Texas | 77008 | United States |
| Houston | Texas | 77074 | United States |
| Houston | Texas | 77081 | United States |
| Houston | Texas | 77083 | United States |
| San Antonio | Texas | 78229 | United States |
| Sugar Land | Texas | 77479 | United States |
| Tomball | Texas | 77375 | United States |
| Salt Lake City | Utah | 84102 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Manassas | Virginia | 20110 | United States |
| Salem | Virginia | 24153 | United States |
| Milwaukee | Wisconsin | 53209 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Welchol | Welchol 625mg tablets Welchol : Welchol 625mg tablets |
| BG001 | Placebo | placebo Placebo : placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m*2 |
| |||||||||||||||||
| baseline body mass index category | number >= 30 kg/m*2 and number <30 kg/m*2 | Number | participants |
| |||||||||||||||||
| Duration of type 2 diabetes | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Hemoglobin A1c | change in HbA1c from baseline to Week 24 | Intent to Treat, Last Observation Carried Forward (LOCF) Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Mean | Standard Error | percentage change of hemoglobin A1c | 24 week |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Plasma Glucose | to determine changes in Glycemic control after 24 weeks on therapy | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to 24 weeks |
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| Secondary | % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units | to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline. | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Number | percentage of participants | 24 weeks |
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| Secondary | % Subjects Achieving an HbA1C Goal of <7.0 | % Subjects achieving an HbA1C goal of <7.0 at 24 weeks | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Number | percentage of participants | 24 weeks |
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| Secondary | % Subjects With a Decrease in FPG >=30 mg/dL | % Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Number | percentage of participants | from baseline to 24 weeks |
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| Secondary | Changes in Total Cholesterol [TC] | To assess the effects of Welchol on changes in total cholesterol [TC] | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to 24 weeks |
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| Secondary | Changes in Low Density Lipoprotein Cholesterol [LDL-C] | To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C] | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to 24 weeks |
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| Secondary | Changes in High Density Lipoprotein Cholesterol [HDL-C] | To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C] | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | md/dL | from baseline to 24 weeks |
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| Secondary | Changes in Non-HDL-C | To assess the effects of Welchol on changes in non-HDL-C | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to 24 weeks |
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| Secondary | Changes in Triglycerides [TG] | To assess the effects of Welchol on changes in triglycerides [TG] | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to 24 weeks |
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| Secondary | Changes in Apolipoprotein A-I (apoA-I) | To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I) | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to 24 weeks |
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| Secondary | Changes in Apolipoprotein B (apoB) | To assess the effects of Welchol on changes in apolipoprotein B (apoB) | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to 24 weeks |
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| Secondary | Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test | To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test | Some participants may not have had lab results for this specific analysis and therefore excluded. | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to 24 weeks |
|
|
January 2009 through December 2011
Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Welchol | Welchol 625mg tablets Welchol : Welchol 625mg tablets | 7 | 175 | 91 | 175 | ||
| EG001 | Placebo | placebo Placebo : placebo | 3 | 171 | 77 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) |
| ||
| hypotension | Vascular disorders | MedDRA (12.0) |
| ||
| suicide attempt | Psychiatric disorders | MedDRA (12.0) |
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| tibia fracture | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| depression | Psychiatric disorders | MedDRA (12.0) |
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| psychotic disorder | Psychiatric disorders | MedDRA (12.0) |
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| alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (12.0) |
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| coronary artery disease | Vascular disorders | MedDRA (12.0) |
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| acute myocardial infarction | Cardiac disorders | MedDRA (12.0) |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) |
| ||
| liver function test abnormal | Hepatobiliary disorders | MedDRA (12.0) |
| ||
| bilirubin increased | Hepatobiliary disorders | MedDRA (12.0) |
| ||
| pyelonephritis | Renal and urinary disorders | MedDRA (12.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| diarrhoea | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (12.0) |
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| bronchitis | Infections and infestations | MedDRA (12.0) |
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| nasopharyngitis | Infections and infestations | MedDRA (12.0) |
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| tooth abcess | Infections and infestations | MedDRA (12.0) |
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| upper respiratory tract infection | Infections and infestations | MedDRA (12.0) |
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| urinary tract infection | Infections and infestations | MedDRA (12.0) |
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| aspartate aminotransferase increased | Investigations | MedDRA (12.0) |
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| blood creatine phosphokinase increased | Investigations | MedDRA (12.0) |
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| c-reactive protein increased | Investigations | MedDRA (12.0) |
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| diabetes mellitus | Metabolism and nutrition disorders | MedDRA (12.0) |
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| hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) |
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| hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) |
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| hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) |
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| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| dizziness | Nervous system disorders | MedDRA (12.0) |
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| headache | Nervous system disorders | MedDRA (12.0) |
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| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) |
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| hypertension | Vascular disorders | MedDRA (12.0) |
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| nausea | Gastrointestinal disorders | MedDRA (12.0) |
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Until coordinated multicenter publication or one year after the study termination, whichever occurs first. After that, submit for Daiichi Sankyo, Inc. (DSI) review and comment at least 45 days before submission. DSI may ask up to 60 additional days, if patentable material is identified.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Metabolic Clinical Development | Daiichi Sankyo Pharma Development | 732-590-5000 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| >= 30 kg/m*2 |
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