| Secondary | Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. | | The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was not used. | Posted | | Least Squares Mean | Standard Error | Percentage of change in HbA1c | | Baseline to 4, 8, 12, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group:Placebo+Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group:Colesevelam+Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| | | Title | Denominators | Categories |
|---|
| Baseline to 4 weeks:Pla+Met, N=128, Col+Met N=129 | | | Title | Measurements |
|---|
| - OG000-0.38± 0.044
- OG001-0.53± 0.044
|
| | Baseline to 8 weeks:Pla+Met, N=123, Col+Met N=125 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate. | 0.0123 | P-Value is for the LS mean difference between treatment groups | Mean Difference (Final Values) | -0.15 | | | 2-Sided | 95 | -0.27 | -0.03 | | | | No | Superiority or Other | | | |
|
| Secondary | Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 4, 8, 12, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo+Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group:Colesevelam+Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | uIU/mL | | Baseline to 4, 8, 12, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group:Placebo+Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group:Colesevelam+Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | ng/mL | | Baseline to 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | 30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | 1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | 2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | 2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | uIU/mL | | Baseline to 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | 2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed = the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Results are presented for both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | ng/mL | | Baseline to 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | percentage of change in LDL-C | | Baseline to 8, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam+Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | percentage of change in non-HDL | | Baseline to 8, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 8, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change of TC | | Baseline to 8, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Median | Inter-Quartile Range | Percentage of change of TG | | Baseline to 8, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change in Apo A-1 | | Baseline to 8, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change in Apo B | | Baseline to 8, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change in Apo C3 | | Baseline to 8, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline to 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. | | OG002 | Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. |
|
| Secondary | Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | nm | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. | | OG002 | Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. |
|
| Secondary | Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary. | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary. | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Primary | Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects. | | The number analyzed equals the full analysis set. The full analysis set included all randomized subjects who took at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline efficacy variable measurement. This analysis set was used for the summary and analysis of all efficacy variables. LOCF was used. | Posted | | Least Squares Mean | Standard Error | Percentage of change of hemoglobin A1C | | Baseline to 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | Percent of Subjects Achieving HbA1c Goal of <7.0% at Weeks 4, 8, 12, and 16 if Baseline HbA1c Was > or = to 7.0% When Given to Drug-naïve, Diabetics | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 4, 8, 12, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of particpants | | Baseline to 4, 8, 12 and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to Weeks 8, and 16 | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to Weeks 8, and 16 | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | lb | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks. |
| |
| Secondary | Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Ratio | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Primary | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. Last Observation Carried Forward was used for 16 week analyses. | Posted | | Least Squares Mean | Standard Error | Percentage of change in LDL-C | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL*hr | | Baseline vs. 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects | These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary. | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percentage of change | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. | | OG002 | Type 2 Diabetes Group: Placebo + Metformin (LOCF) |
|
| Secondary | Percent of Subjects Achieving 2-Hr. Post Meal Glucose Goal of <180 mg/dL When Given to Drug-naïve, Diabetic Subjects From Baseline to Week 16 | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | Percent of Subjects Achieving Hs-C-Reactive Protein Goal of <2.0 mg/L When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Type 2 Diabetes Group: Placebo + Metformin | This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks. | | OG001 | Type 2 Diabetes Group: Colesevelam + Metformin | This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed=the full analysis set (FAS). The FAS included randomized subjects who took at least 1 dose of randomized medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The total treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg once daily. The total treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Median | Inter-Quartile Range | Percentage of change | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Median | Inter-Quartile Range | Percentage of change | | Baseline 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. These 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | nmol/L | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. | | OG002 | Pre-Diabetes Group: Placebo (LOCF) | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG003 | Pre-Diabetes Group: Colesevelam (LOCF) | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
|
| Secondary | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | nm | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. | | OG002 | Pre-Diabetes Group: Placebo (LOCF) | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG003 | Pre-Diabetes Group: Colesevelam (LOCF) | |
|
| Secondary | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary. | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. | | OG002 | Pre-Diabetes Group: Placebo (LOCF) | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG003 |
|
| Secondary | Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 4, 8, 12, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 4, 8, 12, and 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to 4, 8, 12, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks | | | Posted | | Least Squares Mean | Standard Error | ng/mL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | uIU/mL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | ng/mL | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 8, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | lb | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | Change in Ratio | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Area Under the Curve for Plasma Glucose From 0 to 120 Minutes During the Oral Glucose Tolerance Tests in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Least Squares Mean | Standard Error | mg/dL*hr | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Achievement of <140 mg/dL Plasma Glucose 2 Hours Post the Oral Glucose Tolerance Test in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was >or= to 140 mg/dL From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Achievement of <110 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 110 mg/dL From Baseline to 4, 8, 12, and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF | Posted | | Number | | Percent of participants | | Baseline to 4, 8, 12, and 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
| |
| Secondary | Percent Achievement of <100 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 100 mg/dL From Baseline to 4, 8, 12 and 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 4, 8, 12 and 16 weeks | | | | ID | Title | Description |
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| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
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| Secondary | Percent Achievement of <140 mg/dL Plasma Glucose Post 2 Hour Glucose Tolerance Test and Fasting Plasma Glucose <110 mg/dL in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
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| Secondary | Percent Achievement of Hs-C-Reactive Protein <2.0 mg/L in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 2.0 mg/L From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
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| Secondary | Percent of Subjects Meeting Type 2 Diabetes Criteria (Fasting Plasma Glucose >or= to 126 mg/dL or Plasma Glucose >or= to 200 mg/dL Post 2 Hr Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | | The No. analyzed equals the full analysis set (FAS). The FAS included all randomized subjects who took at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline efficacy variable measurement. The FAS was used for the summary and analysis of all efficacy variables. The 16 week analyses are both LOCF and no LOCF. | Posted | | Number | | Percent of participants | | Baseline to 16 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Pre-Diabetes Group: Placebo | This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks. | | OG001 | Pre-Diabetes Group: Colesevelam | This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks. |
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