Trial Outcomes & Findings for Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients. (NCT NCT00570739)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

502 participants

Primary outcome timeframe

Baseline to 16 weeks

Results posted on

2010-07-27

Participant Flow

Two cohorts of participants, type 2 diabetics (T2DM) and pre-diabetics, were recruited from 07 Jan 2008 to 15 Dec 2008. The sites were located in Colombia, India, Mexico, and the USA. The sites included private physician offices, group practices, clinics, hospitals, institutes, and university centers.

Due to the different metabolic nature of the two groups the "Total" column under Baseline Characteristics is populated with data for the diabetic group, except where the total could be obtained by just adding the number of participants. Please note: in the outcomes section, LOCF=Last Observation carried forward

Participant milestones

Participant milestones
Measure	Type 2 Diabetes Group: Placebo + Metformin This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.	Type 2 Diabetes Group: Colesevelam + Metformin This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.	Pre-diabetic Group: Placebo This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.	Pre-diabetic Group: Colesevelam This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
Overall Study STARTED	141	145	108	108
Overall Study COMPLETED	120	124	92	96
Overall Study NOT COMPLETED	21	21	16	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Type 2 Diabetes Group: Placebo + Metformin This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.	Type 2 Diabetes Group: Colesevelam + Metformin This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.	Pre-diabetic Group: Placebo This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.	Pre-diabetic Group: Colesevelam This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
Overall Study Adverse Event	8	6	2	2
Overall Study Lost to Follow-up	4	5	4	1
Overall Study Physician Decision	1	1	0	0
Overall Study Withdrawal by Subject	7	7	3	5
Overall Study Required restricted medication	0	0	1	0
Overall Study Met discontinuation criteria	1	0	1	1
Overall Study Other	0	2	5	3

Baseline Characteristics

Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Type 2 Diabetes Group: Placebo + Metformin n=141 Participants This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.	Type 2 Diabetes Group: Colesevelam + Metformin n=145 Participants This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.	Pre-diabetic Group: Placebo n=108 Participants This group received 6 colesevelam matching placebo tablets once per day for 16 weeks	Pre-diabetic Group: Colesevelam n=108 Participants This group received 6 colesevelam tablets, 625mg, once per day for 16 weeks.	Total n=502 Participants Total of all reporting groups
Age Continuous	53.9 years STANDARD_DEVIATION 10.11 • n=5 Participants	52.7 years STANDARD_DEVIATION 11.46 • n=7 Participants	55.7 years STANDARD_DEVIATION 11.14 • n=5 Participants	53.3 years STANDARD_DEVIATION 12.27 • n=4 Participants	53.3 years STANDARD_DEVIATION 10.81 • n=21 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	76 Participants n=7 Participants	81 Participants n=5 Participants	68 Participants n=4 Participants	310 Participants n=21 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	69 Participants n=7 Participants	27 Participants n=5 Participants	40 Participants n=4 Participants	192 Participants n=21 Participants
Race/Ethnicity, Customized Asian	30 Participants n=5 Participants	32 Participants n=7 Participants	15 Participants n=5 Participants	14 Participants n=4 Participants	91 Participants n=21 Participants
Race/Ethnicity, Customized Black/African American	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race/Ethnicity, Customized White	20 Participants n=5 Participants	21 Participants n=7 Participants	14 Participants n=5 Participants	11 Participants n=4 Participants	66 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	90 Participants n=5 Participants	89 Participants n=7 Participants	78 Participants n=5 Participants	82 Participants n=4 Participants	339 Participants n=21 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	17 participants n=5 Participants	16 participants n=4 Participants	93 participants n=21 Participants
Region of Enrollment Mexico	56 participants n=5 Participants	58 participants n=7 Participants	40 participants n=5 Participants	41 participants n=4 Participants	195 participants n=21 Participants
Region of Enrollment Colombia	25 participants n=5 Participants	26 participants n=7 Participants	36 participants n=5 Participants	37 participants n=4 Participants	124 participants n=21 Participants
Region of Enrollment India	30 participants n=5 Participants	31 participants n=7 Participants	15 participants n=5 Participants	14 participants n=4 Participants	90 participants n=21 Participants
Previously diagnosed with neither diabetes nor pre-diabetes	14 Participant n=5 Participants	15 Participant n=7 Participants	26 Participant n=5 Participants	22 Participant n=4 Participants	77 Participant n=21 Participants
Previously diagnosed with pre-diabetes	17 Participant n=5 Participants	21 Participant n=7 Participants	81 Participant n=5 Participants	85 Participant n=4 Participants	204 Participant n=21 Participants
Previously diagnosed with type 2 diabetes	110 Participant n=5 Participants	109 Participant n=7 Participants	1 Participant n=5 Participants	1 Participant n=4 Participants	221 Participant n=21 Participants
Body Mass Index	29.78 kg/m squared STANDARD_DEVIATION 4.44 • n=5 Participants	30.58 kg/m squared STANDARD_DEVIATION 4.669 • n=7 Participants	30.82 kg/m squared STANDARD_DEVIATION 4.18 • n=5 Participants	30.93 kg/m squared STANDARD_DEVIATION 4.89 • n=4 Participants	30.19 kg/m squared STANDARD_DEVIATION 4.57 • n=21 Participants
Fasting glucose	145.7 mg/dL STANDARD_DEVIATION 37.54 • n=5 Participants	153.4 mg/dL STANDARD_DEVIATION 39.04 • n=7 Participants	106.8 mg/dL STANDARD_DEVIATION 14.80 • n=5 Participants	104.1 mg/dL STANDARD_DEVIATION 11.33 • n=4 Participants	149.6 mg/dL STANDARD_DEVIATION 38.43 • n=21 Participants
Fasting insulin	12.82 uIU/mL STANDARD_DEVIATION 8.44 • n=5 Participants	13.86 uIU/mL STANDARD_DEVIATION 15.75 • n=7 Participants	11.03 uIU/mL STANDARD_DEVIATION 5.55 • n=5 Participants	13.12 uIU/mL STANDARD_DEVIATION 8.75 • n=4 Participants	13.34 uIU/mL STANDARD_DEVIATION 12.66 • n=21 Participants
Glucose 2 hours after meal	220.3 mg/dL STANDARD_DEVIATION 58.68 • n=5 Participants	234.7 mg/dL STANDARD_DEVIATION 71.36 • n=7 Participants	153.7 mg/dL STANDARD_DEVIATION 39.81 • n=5 Participants	153.7 mg/dL STANDARD_DEVIATION 37.90 • n=4 Participants	227.7 mg/dL STANDARD_DEVIATION 65.74 • n=21 Participants
Height	160.6 cm STANDARD_DEVIATION 10.64 • n=5 Participants	162.3 cm STANDARD_DEVIATION 9.67 • n=7 Participants	159.1 cm STANDARD_DEVIATION 9.95 • n=5 Participants	160.8 cm STANDARD_DEVIATION 9.96 • n=4 Participants	161.5 cm STANDARD_DEVIATION 10.18 • n=21 Participants
Hemoglobin A1c	7.53 Percent STANDARD_DEVIATION 0.94 • n=5 Participants	7.76 Percent STANDARD_DEVIATION 1.04 • n=7 Participants	6.07 Percent STANDARD_DEVIATION 0.45 • n=5 Participants	6.02 Percent STANDARD_DEVIATION 0.46 • n=4 Participants	7.65 Percent STANDARD_DEVIATION 1.0 • n=21 Participants
Low Density Lipoprotein Cholesterol	135.5 mg/dL STANDARD_DEVIATION 26.66 • n=5 Participants	129.1 mg/dL STANDARD_DEVIATION 23.08 • n=7 Participants	136.8 mg/dL STANDARD_DEVIATION 28.48 • n=5 Participants	132.8 mg/dL STANDARD_DEVIATION 23.88 • n=4 Participants	132.2 mg/dL STANDARD_DEVIATION 25.07 • n=21 Participants
Weight	77.26 kg STANDARD_DEVIATION 16.17 • n=5 Participants	80.84 kg STANDARD_DEVIATION 15.53 • n=7 Participants	78.18 kg STANDARD_DEVIATION 13.76 • n=5 Participants	80.63 kg STANDARD_DEVIATION 18.02 • n=4 Participants	79.08 kg STANDARD_DEVIATION 15.92 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline to 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=137 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=138 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.	-0.83 Percentage of change of hemoglobin A1C Standard Error 0.064	-1.09 Percentage of change of hemoglobin A1C Standard Error 0.064	—	—

PRIMARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=104 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=103 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks	1.70 Percentage of change in LDL-C Standard Error 2.054	-13.89 Percentage of change in LDL-C Standard Error 2.088	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=128 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=129 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. Baseline to 4 weeks:Pla+Met, N=128, Col+Met N=129	-0.38 Percentage of change in HbA1c Standard Error 0.044	-0.53 Percentage of change in HbA1c Standard Error 0.044	—	—
Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. Baseline to 8 weeks:Pla+Met, N=123, Col+Met N=125	-0.67 Percentage of change in HbA1c Standard Error 0.055	-0.84 Percentage of change in HbA1c Standard Error 0.055	—	—
Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. Baseline to 12 weeks:Pla+Met, N=115, Col+Met N=123	-0.86 Percentage of change in HbA1c Standard Error 0.062	-1.05 Percentage of change in HbA1c Standard Error 0.059	—	—
Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks. Baseline to 16 weeks:Pla+Met, N=118, Col+Met N=122	-0.92 Percentage of change in HbA1c Standard Error 0.064	-1.17 Percentage of change in HbA1c Standard Error 0.063	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=130 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=131 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks baseline to 4 weeks Pla+Met N=130, Col+Met N=131	-19.0 mg/dL Standard Error 2.31	-24.0 mg/dL Standard Error 2.30	—	—
Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks baseline to 8 weeks:Pla+Met N=122, Col+Met N=126	-24.3 mg/dL Standard Error 1.97	-27.6 mg/dL Standard Error 1.94	—	—
Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks baseline to 12 weeks:Pla+Met N=121, Col+Met N=125	-27.3 mg/dL Standard Error 2.21	-28.4 mg/dL Standard Error 2.18	—	—
Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks baseline to 16 weeks:Pla+Met N=119, Col+Met N=124	-28.0 mg/dL Standard Error 2.21	-30.5 mg/dL Standard Error 2.16	—	—
Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks baseline to 16wks LOCF:Pla+Met N=137,Col+Met N=138	-25.9 mg/dL Standard Error 2.19	-28.0 mg/dL Standard Error 2.18	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=127 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=127 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 4 weeks:Pla+Met, N=127, Col+Met N=127	-2.124 uIU/mL Standard Error 0.7219	-2.427 uIU/mL Standard Error 0.7219	—	—
Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 8 weeks:Pla+Met, N=124, Col+Met N=126	-1.992 uIU/mL Standard Error 0.5407	-3.007 uIU/mL Standard Error 0.5376	—	—
Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 12 weeks:Pla+Met, N=117, Col+Met N=123	-2.204 uIU/mL Standard Error 0.5159	-3.708 uIU/mL Standard Error 0.5048	—	—
Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 16 weeks:Pla+Met, N=119, Col+Met N=124	-2.978 uIU/mL Standard Error 0.7379	-2.802 uIU/mL Standard Error 0.7217	—	—
Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to16wks LOCF:Pla+Met,N=137,Col+Met N=138	-2.847 uIU/mL Standard Error 0.6655	-2.637 uIU/mL Standard Error 0.6644	—	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=120 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=124 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-0.295 ng/mL Standard Error 0.0695	-0.449 ng/mL Standard Error 0.0683	—	—
Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16Wks LOCF Pla+Met N=133,Col+Met N=134	-0.284 ng/mL Standard Error 0.0650	-0.426 ng/mL Standard Error 0.0644	—	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=120 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=123 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 weeks	-33.1 mg/dL Standard Error 3.46	-33.1 mg/dL Standard Error 3.43	—	—
30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16Wks LOCF Pla+Met N=133,Col+Met N=132	-29.4 mg/dL Standard Error 3.44	-30.4 mg/dL Standard Error 3.45	—	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=118 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=120 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-35.0 mg/dL Standard Error 3.91	-41.9 mg/dL Standard Error 3.88	—	—
1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF:N=131 Pla; N=129 Colesev	-31.4 mg/dL Standard Error 3.92	-39.1 mg/dL Standard Error 3.94	—	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=115 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=120 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-33.0 mg/dL Standard Error 4.11	-38.14 mg/dL Standard Error 4.02	—	—
2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=129, Met N=127	-29.4 mg/dL Standard Error 4.18	-36.2 mg/dL Standard Error 4.14	—	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=116 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=118 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-11.601 uIU/mL Standard Error 3.2794	-10.551 uIU/mL Standard Error 3.2370	—	—
2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=129, Met N=127	-8.592 uIU/mL Standard Error 3.4395	-10.156 uIU/mL Standard Error 3.4399	—	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=117 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=121 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-0.317 ng/mL Standard Error 0.2424	-0.102 ng/mL Standard Error 0.2373	—	—
2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=129, Met N=130	-0.205 ng/mL Standard Error 0.2406	-0.135 ng/mL Standard Error 0.2374	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=122 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=124 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	-5.83 percentage of change in LDL-C Standard Error 1.631	-24.01 percentage of change in LDL-C Standard Error 1.614	—	—
The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=119, Met N=124	-4.94 percentage of change in LDL-C Standard Error 1.852	-22.02 percentage of change in LDL-C Standard Error 1.813	—	—
The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=137, Met N=136	-5.11 percentage of change in LDL-C Standard Error 1.695	-21.44 percentage of change in LDL-C Standard Error 1.700	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=122 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=125 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	-5.79 percentage of change in non-HDL Standard Error 1.327	-18.19 percentage of change in non-HDL Standard Error 1.316	—	—
Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=119, Met N=124	-5.08 percentage of change in non-HDL Standard Error 1.460	-14.36 percentage of change in non-HDL Standard Error 1.436	—	—
Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=137, Met N=136	-5.38 percentage of change in non-HDL Standard Error 1.338	-13.70 percentage of change in non-HDL Standard Error 1.346	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=122 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=125 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	2.98 Percentage of change Standard Error 1.506	5.61 Percentage of change Standard Error 1.488	—	—
Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=119, Met N=124	7.46 Percentage of change Standard Error 1.277	8.78 Percentage of change Standard Error 1.250	—	—
Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=137, Met N=136	6.58 Percentage of change Standard Error 1.160	8.39 Percentage of change Standard Error 1.165	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=122 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=125 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	-4.46 Percentage of change of TC Standard Error 1.009	-13.26 Percentage of change of TC Standard Error 1.000	—	—
Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=119, Met=124	-2.85 Percentage of change of TC Standard Error 1.217	-9.79 Percentage of change of TC Standard Error 1.197	—	—
Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=137, Met=136	-3.22 Percentage of change of TC Standard Error 1.115	-9.31 Percentage of change of TC Standard Error 1.121	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=122 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=125 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	-7.39 Percentage of change of TG Interval -11.41 to 0.58	1.28 Percentage of change of TG Interval -4.48 to 5.58	—	—
Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=119, Met N=124	-7.12 Percentage of change of TG Interval -25.58 to 7.32	8.63 Percentage of change of TG Interval -8.74 to 36.85	—	—
Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=137, Met N=136	-9.55 Percentage of change of TG Interval -24.13 to 14.4	8.80 Percentage of change of TG Interval 6.25 to 15.88	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=118 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=124 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	3.30 Percentage of change in Apo A-1 Standard Error 1.047	6.12 Percentage of change in Apo A-1 Standard Error 1.027	—	—
Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=113, Met N=120	4.86 Percentage of change in Apo A-1 Standard Error 1.052	8.51 Percentage of change in Apo A-1 Standard Error 1.024	—	—
Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=133, Met N=134	4.02 Percentage of change in Apo A-1 Standard Error 0.957	8.45 Percentage of change in Apo A-1 Standard Error 0.953	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=118 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=124 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	-4.59 Percentage of change in Apo B Standard Error 1.184	16.15 Percentage of change in Apo B Standard Error 1.158	—	—
Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=113, Met N=120	-3.89 Percentage of change in Apo B Standard Error 1.340	-13.42 Percentage of change in Apo B Standard Error 1.307	—	—
Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=133, Met N=134	-4.20 Percentage of change in Apo B Standard Error 1.242	-12.17 Percentage of change in Apo B Standard Error 1.239	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=122 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=125 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	0.01 Percentage of change in Apo C3 Standard Error 2.527	12.58 Percentage of change in Apo C3 Standard Error 2.495	—	—
Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=117, Met N=120	4.06 Percentage of change in Apo C3 Standard Error 2.932	18.58 Percentage of change in Apo C3 Standard Error 2.871	—	—
Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=136, N=136	2.82 Percentage of change in Apo C3 Standard Error 2.621	17.89 Percentage of change in Apo C3 Standard Error 2.620	—	—

SECONDARY outcome

Timeframe: Baseline to 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=119 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=119 Participants 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.	Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) n=133 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) n=129 Participants 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.
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Total Very Low Density Lipoprotein (VLDL) Particle	-4.03 nmol/L Standard Error 2.361	2.81 nmol/L Standard Error 2.355	-3.71 nmol/L Standard Error 2.167	2.68 nmol/L Standard Error 2.188
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks VLDL Chylomicron Particles	-0.58 nmol/L Standard Error 0.554	1.73 nmol/L Standard Error 0.552	-0.58 nmol/L Standard Error 0.507	1.76 nmol/L Standard Error 0.511
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Medium VLDL Particles	-2.31 nmol/L Standard Error 1.496	4.84 nmol/L Standard Error 1.492	-2.28 nmol/L Standard Error 1.383	4.85 nmol/L Standard Error 1.396
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Small VLDL Particles	-1.12 nmol/L Standard Error 1.536	-4.00 nmol/L Standard Error 1.532	-0.83 nmol/L Standard Error 1.413	-4.06 nmol/L Standard Error 1.426
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Total Low Density Lipoprotein (LDL) Particles	-104.0 nmol/L Standard Error 27.04	-303.3 nmol/L Standard Error 27.05	-109.5 nmol/L Standard Error 25.49	-295.5 nmol/L Standard Error 25.77
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Intermediate Density Lipoprotein Particles	-9.6 nmol/L Standard Error 4.24	-21.3 nmol/L Standard Error 4.24	-8.9 nmol/L Standard Error 4.03	-19.6 nmol/L Standard Error 4.08
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Large LDL Particles	52.1 nmol/L Standard Error 15.74	-25.5 nmol/L Standard Error 15.69	45.1 nmol/L Standard Error 14.60	-24.2 nmol/L Standard Error 14.73
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Small LDL Particles	-146.9 nmol/L Standard Error 31.63	-256.7 nmol/L Standard Error 31.63	-145.9 nmol/L Standard Error 29.52	-252.7 nmol/L Standard Error 29.84
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Medium Small LDL Particles	-32.0 nmol/L Standard Error 7.16	-48.2 nmol/L Standard Error 7.15	-30.8 nmol/L Standard Error 6.72	-46.2 nmol/L Standard Error 6.78
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Very Small LDL Particles	-115.0 nmol/L Standard Error 24.96	-208.7 nmol/L Standard Error 24.97	-115.3 nmol/L Standard Error 23.31	-206.6 nmol/L Standard Error 23.57
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Total High Density Lipoprotein (HDL) Particles	1.47 nmol/L Standard Error 0.352	2.41 nmol/L Standard Error 0.351	1.34 nmol/L Standard Error 0.332	2.35 nmol/L Standard Error 0.335
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Large HDL Particles	0.64 nmol/L Standard Error 0.160	1.09 nmol/L Standard Error 0.161	0.55 nmol/L Standard Error 0.153	1.00 nmol/L Standard Error 0.155
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Medium HDL Particles	-0.19 nmol/L Standard Error 0.275	0.50 nmol/L Standard Error 0.274	-0.26 nmol/L Standard Error 0.259	0.59 nmol/L Standard Error 0.261
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Small HDL Particles	1.04 nmol/L Standard Error 0.385	0.74 nmol/L Standard Error 0.384	1.05 nmol/L Standard Error 0.362	0.70 nmol/L Standard Error 0.366

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=119 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=119 Participants 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.	Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) n=133 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) n=129 Participants 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.
Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Very Low Density Lipoprotein Particles	-0.80 nm Standard Error 0.868	1.41 nm Standard Error 0.866	-1.02 nm Standard Error 0.796	1.73 nm Standard Error 0.804
Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Low Density Lipoprotein Particles	0.20 nm Standard Error 0.053	0.15 nm Standard Error 0.053	0.19 nm Standard Error 0.049	0.15 nm Standard Error 0.050
Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks High Density Lipoprotein Particles	0.08 nm Standard Error 0.023	0.17 nm Standard Error 0.023	0.08 nm Standard Error 0.021	0.17 nm Standard Error 0.022

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=119 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=119 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-8.5 mg/dL Standard Error 6.44	17.6 mg/dL Standard Error 6.43	—	—
Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=133, Met N=129	-9.0 mg/dL Standard Error 5.88	18.2 mg/dL Standard Error 5.93	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=119 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=119 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-7.4 mg/dL Standard Error 6.36	22.4 mg/dL Standard Error 6.34	—	—
Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=133, Met N= 129	-7.9 mg/dL Standard Error 5.81	22.9 mg/dL Standard Error 5.86	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=119 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=119 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	3.2 mg/dL Standard Error 0.62	5.8 mg/dL Standard Error 0.62	—	—
Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=133, Met N=129	2.9 mg/dL Standard Error 0.59	5.6 mg/dL Standard Error 0.60	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=90 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=93 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 4 Weeks	31.1 Percent of participants	25.8 Percent of participants	—	—
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 Baseline to 8 Weeks: Pla N=87, Met N=91	47.1 Percent of participants	48.4 Percent of participants	—	—
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 Baseline to 12 Weeks: Pla N=79, Met N=89	59.5 Percent of participants	64.0 Percent of participants	—	—
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 Baseline to 16 Weeks: Pla N=83, Met N=87	59.0 Percent of participants	72.4 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=95, Met N=99	55.8 Percent of participants	66.7 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12 and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=122 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=125 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects Baseline to 4 Weeks	9.0 Percent of particpants	24.8 Percent of particpants	—	—
Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects Baseline to 8 Weeks: Pla N=118, Met N=121	23.7 Percent of particpants	36.4 Percent of particpants	—	—
Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects Baseline to 12 Weeks: Pla N=110, Met N=119	38.2 Percent of particpants	51.3 Percent of particpants	—	—
Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects Baseline to 16 Weeks: Pla N=114, Met N=118	44.7 Percent of particpants	55.9 Percent of particpants	—	—
Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects Baseline to 16 Weeks LOCF: Pla N=131, Met N=134	41.2 Percent of particpants	52.2 Percent of particpants	—	—

SECONDARY outcome

Timeframe: Baseline to Weeks 8, and 16

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=117 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=115 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects Baseline to 8 Weeks	16.2 Percent of participants	54.8 Percent of participants	—	—
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects Baseline to 16 Weeks: Pla N=114, Met N=116	17.5 Percent of participants	50.0 Percent of participants	—	—
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects Baseline to 16 Weeks LOCF: Pla N=131, Met N=127	18.3 Percent of participants	48.0 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to Weeks 8, and 16

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=122 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=124 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics Baseline to 8 Weeks	1.6 Percent of participants	13.7 Percent of participants	—	—
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics Baseline to 16 Weeks: Pla N=119, Met N=124	5.0 Percent of participants	12.9 Percent of participants	—	—
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics Baseline to 16 Weeks LOCF: Pla N=1137, Met N=136	4.4 Percent of participants	12.5 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=120 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=124 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-5.11 lb Standard Error 0.564	-4.91 lb Standard Error 0.552	—	—
Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=134, Met N=134	-4.71 lb Standard Error 0.523	-4.56 lb Standard Error 0.519	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=120 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=124 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-0.0033 Ratio Standard Error 0.00329	-0.0067 Ratio Standard Error 0.00323	—	—
Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=134, Met N=134	-0.0030 Ratio Standard Error 0.00306	-0.0065 Ratio Standard Error 0.00304	—	—

SECONDARY outcome

Timeframe: Baseline vs. 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=114 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=116 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT Baseline to 16 Weeks	-67.10 mg/dL*hr Standard Error 6.305	-77.56 mg/dL*hr Standard Error 6.266	—	—
Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT Baseline to 16 Weeks LOCF: Pla N=127, Met N=124	-60.34 mg/dL*hr Standard Error 6.460	-71.88 mg/dL*hr Standard Error 6.524	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=119 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=119 Participants 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.	Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) n=133 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) n=129 Participants 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.
Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects Calculated High Density Lipoprotein-Cholesterol	9.51 Percentage of change	17.86 Percentage of change	8.70 Percentage of change	17.39 Percentage of change
Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects Calculated Total Triglycerides	1.67 Percentage of change	14.48 Percentage of change	0.99 Percentage of change	15.11 Percentage of change
Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects Calc.Very Low Density Lipoprotein Triglycerides	7.48 Percentage of change	30.28 Percentage of change	6.62 Percentage of change	31.34 Percentage of change

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=85 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=89 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 16 Weeks	41.2 Percent of participants	41.6 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=95, Met N=97	37.9 Percent of participants	41.2 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=78 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=82 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 16 Weeks	21.8 Percent of participants	22.0 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=91, Met N=90	19.8 Percent of participants	20.0 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=98 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=98 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	1.74 Percentage of change Standard Error 1.888	-17.88 Percentage of change Standard Error 1.921	—	—
Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=92, Col N=95	2.39 Percentage of change Standard Error 2.191	-15.08 Percentage of change Standard Error 2.209	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=98 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=98 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	1.50 Percentage of change Standard Error 1.433	-10.98 Percentage of change Standard Error 1.461	—	—
Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=92, Col N=95	1.20 Percentage of change Standard Error 1.850	-9.08 Percentage of change Standard Error 1.867	—	—
Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=104, Col N=103	0.69 Percentage of change Standard Error 1.739	-8.37 Percentage of change Standard Error 1.770	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=98 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=98 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	-1.12 Percentage of change Standard Error 1.398	2.85 Percentage of change Standard Error 1.433	—	—
Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=92, Col N=95	4.42 Percentage of change Standard Error 1.580	3.57 Percentage of change Standard Error 1.601	—	—
Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=104, Col N=103	4.06 Percentage of change Standard Error 1.447	3.56 Percentage of change Standard Error 1.481	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=99 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=98 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	0.77 Percentage of change Standard Error 1.169	-8.15 Percentage of change Standard Error 1.206	—	—
Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=92, Col N=95	1.66 Percentage of change Standard Error 1.519	-6.59 Percentage of change Standard Error 1.536	—	—
Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=104, Col N=103	1.22 Percentage of change Standard Error 1.422	-6.01 Percentage of change Standard Error 1.452	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=96 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=95 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	-.032 Percentage of change Standard Error 1.150	3.18 Percentage of change Standard Error 1.190	—	—
Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=89, Col N=94	3.53 Percentage of change Standard Error 1.312	5.67 Percentage of change Standard Error 1.323	—	—
Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=102, Col N=102	3.68 Percentage of change Standard Error 1.205	5.46 Percentage of change Standard Error 1.232	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=96 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=95 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	1.22 Percentage of change Standard Error 1.435	-8.62 Percentage of change Standard Error 1.487	—	—
Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=89, Col N=94	0.67 Percentage of change Standard Error 1.788	-8.00 Percentage of change Standard Error 1.807	—	—
Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=102, Col N=102	0.57 Percentage of change Standard Error 1.648	-7.52 Percentage of change Standard Error 1.685	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=94 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=95 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	3.91 Percentage of change Standard Error 3.301	17.71 Percentage of change Standard Error 3.043	—	—
Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=88, Col N=91	9.31 Percentage of change Standard Error 5.126	20.89 Percentage of change Standard Error 5.231	—	—
Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=100, Col N=102	9.38 Percentage of change Standard Error 4.627	19.83 Percentage of change Standard Error 4.611	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=99 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=98 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 8 Weeks	0.00 Percentage of change Interval -6.95 to 7.69	16.57 Percentage of change Interval 4.94 to 25.83	—	—
Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=92, Col N=95	-4.61 Percentage of change Interval -10.46 to 5.21	5.91 Percentage of change Interval -0.67 to 13.27	—	—
Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks Baseline to 16 Weeks: Pla N=104, Col N=103	-4.35 Percentage of change Interval -9.85 to 5.66	5.91 Percentage of change Interval 0.0 to 13.17	—	—

SECONDARY outcome

Timeframe: Baseline 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=92 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=95 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-11.04 Percentage of change Interval -34.62 to 23.79	-13.43 Percentage of change Interval -47.53 to 26.39	—	—
Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to16 LOCF: Pla N=102, Col N=101	-10.24 Percentage of change Interval -35.78 to 21.8	-14.12 Percentage of change Interval -46.48 to 20.93	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=89 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=93 Participants 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.	Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) n=99 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) n=99 Participants 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.
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Total Very Low Density Lipoprotein (VLDL) Particle	1.83 nmol/L Standard Error 3.363	1.92 nmol/L Standard Error 3.337	0.72 nmol/L Standard Error 3.132	2.25 nmol/L Standard Error 3.149
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Large VLDL Chylomicron Particles	-.80 nmol/L Standard Error 0.459	1.64 nmol/L Standard Error 0.453	-0.86 nmol/L Standard Error 0.424	1.53 nmol/L Standard Error 0.426
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Medium VLDL Particles	1.56 nmol/L Standard Error 2.004	6.59 nmol/L Standard Error 1.986	1.15 nmol/L Standard Error 1.890	6.40 nmol/L Standard Error 1.895
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Small VLDL Particles	1.15 nmol/L Standard Error 1.967	-6.34 nmol/L Standard Error 1.951	0.52 nmol/L Standard Error 1.837	-5.73 nmol/L Standard Error 1.844
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Total Low Density Lipoprotein (LDL) Particles	-24.7 nmol/L Standard Error 38.15	-135.2 nmol/L Standard Error 37.83	-25.7 nmol/L Standard Error 35.97	-138.4 nmol/L Standard Error 36.15
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Intermediate Density Lipoprotein (LDL) Particles	-14.9 nmol/L Standard Error 5.71	-15.3 nmol/L Standard Error 5.69	-14.7 nmol/L Standard Error 5.37	-17.0 nmol/L Standard Error 5.41
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Large LDL Particles	91.3 nmol/L Standard Error 29.20	27.6 nmol/L Standard Error 28.99	91.3 nmol/L Standard Error 26.79	27.5 nmol/L Standard Error 26.93
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Small LDL Particles	-110.9 nmol/L Standard Error 44.15	-148.6 nmol/L Standard Error 43.79	-102.5 nmol/L Standard Error 41.72	-149.4 nmol/L Standard Error 41.94
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Medium Small LDL Particles	-22.5 nmol/L Standard Error 9.02	-28.2 nmol/L Standard Error 8.95	-21.5 nmol/L Standard Error 8.48	-28.3 nmol/L Standard Error 8.52
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Very Small LDL Particles	-78.3 nmol/L Standard Error 35.60	-120.3 nmol/L Standard Error 35.32	-81.0 nmol/L Standard Error 33.68	-121.0 nmol/L Standard Error 33.86
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Total High Density Lipoprotein (HDL) Particles	0.30 nmol/L Standard Error 0.456	0.28 nmol/L Standard Error 0.452	0.38 nmol/L Standard Error 0.428	0.28 nmol/L Standard Error 0.430
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Large HDL Particles	0.51 nmol/L Standard Error 0.211	1.09 nmol/L Standard Error 0.210	0.53 nmol/L Standard Error 0.197	1.10 nmol/L Standard Error 0.198
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Medium HDL Particles	-0.23 nmol/L Standard Error 0.335	-0.03 nmol/L Standard Error 0.334	-0.24 nmol/L Standard Error 0.310	-0.05 nmol/L Standard Error 0.312
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Small HDL Particles	0.04 nmol/L Standard Error 0.475	-0.77 nmol/L Standard Error 0.471	0.10 nmol/L Standard Error 0.450	-0.75 nmol/L Standard Error 0.453

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=89 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=93 Participants 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.	Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) n=99 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) n=99 Participants 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.
Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Very Low Density Lipoprotein Particles	-1.85 nm Standard Error 0.956	4.15 nm Standard Error 0.948	-1.43 nm Standard Error 0.877	3.89 nm Standard Error 0.883
Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks Low Density Lipoprotein Particles	.23 nm Standard Error 0.068	0.11 nm Standard Error 0.068	0.23 nm Standard Error 0.064	0.12 nm Standard Error 0.065
Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks High Density Lipoprotein Particles	0.06 nm Standard Error 0.026	0.15 nm Standard Error 0.026	0.05 nm Standard Error 0.024	0.15 nm Standard Error 0.024

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=89 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=93 Participants 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.	Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) n=99 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) n=99 Participants 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.
Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks Changes in Calculated Total Triglycerides	-5.0 mg/dL Standard Error 5.97	19.4 mg/dL Standard Error 5.91	-6.4 mg/dL Standard Error 5.60	18.0 mg/dL Standard Error 5.62
Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks Changes: Calculated Very Low Density Triglycerides	-4.6 mg/dL Standard Error 5.70	21.7 mg/dL Standard Error 5.64	-5.9 mg/dL Standard Error 5.34	20.6 mg/dL Standard Error 5.36
Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks Changes in Calculated High Density Lipoprotein -C	1.4 mg/dL Standard Error 0.75	2.9 mg/dL Standard Error 0.74	1.4 mg/dL Standard Error 0.69	2.9 mg/dL Standard Error 0.69

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=100 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=96 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 4 weeks	-0.06 Percentage of change Standard Error 0.026	-0.09 Percentage of change Standard Error 0.028	—	—
Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 8 weeks: Pla N=98, Col N=96	-0.06 Percentage of change Standard Error 0.026	-0.10 Percentage of change Standard Error 0.026	—	—
Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 12 weeks: Pla N=94, Col N=94	-0.05 Percentage of change Standard Error 0.026	-0.11 Percentage of change Standard Error 0.027	—	—
Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 16 weeks: Pla N=90, Col N=95	-0.03 Percentage of change Standard Error 0.034	-0.11 Percentage of change Standard Error 0.034	—	—
Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 16 weeks LOCF: Pla N=106, Col N=103	-0.03 Percentage of change Standard Error 0.030	-0.12 Percentage of change Standard Error 0.031	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=101 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=97 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 4 weeks	0.7 Percentage of change Standard Error 0.95	-3.5 Percentage of change Standard Error 0.97	—	—
Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 8 weeks: Pla N=97, Col N=97	-1.1 Percentage of change Standard Error 0.94	-3.1 Percentage of change Standard Error 0.95	—	—
Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 12 weeks: Pla N=95, Col N=95	0.4 Percentage of change Standard Error 1.11	-2.4 Percentage of change Standard Error 1.13	—	—
Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 16 weeks: Pla N=91, Col N=95	-0.5 Percentage of change Standard Error 1.87	-2.8 Percentage of change Standard Error 1.86	—	—
Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 16 weeks LOCF: Pla N=106, Col N=103	-0.5 Percentage of change Standard Error 1.65	-3.1 Percentage of change Standard Error 1.67	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=95 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=93 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 4 Weeks	-1.269 Percentage of change Standard Error 0.6651	-0.348 Percentage of change Standard Error 0.6769	—	—
Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 8 Weeks: Pla N=94, Col N=97	-1.208 Percentage of change Standard Error 0.4377	-0.513 Percentage of change Standard Error 0.4377	—	—
Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 12 Weeks: Pla N=93, Col N=93	-0.848 Percentage of change Standard Error 0.4371	-2.066 Percentage of change Standard Error 0.4463	—	—
Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 16 Weeks: Pla N=90, Col N=94	-0.063 Percentage of change Standard Error 1.2082	-0.497 Percentage of change Standard Error 1.1980	—	—
Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks Baseline to 16 Weeks LOCF: Pla N=105, Col N=102	-0.019 Percentage of change Standard Error 1.0597	-0.512 Percentage of change Standard Error 1.0770	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=91 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=94 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	0.039 ng/mL Standard Error 0.1124	-0.050 ng/mL Standard Error 0.1132	—	—
Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=101, Col N=100	0.049 ng/mL Standard Error 0.1041	-0.057 ng/mL Standard Error 0.1059	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=88 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=94 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-0.9 mg/dL Standard Error 3.82	-1.8 mg/dL Standard Error 3.71	—	—
Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=96, Col N=97	-1.3 mg/dL Standard Error 3.60	-2.5 mg/dL Standard Error 3.58	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=85 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=95 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-1.0 mg/dL Standard Error 4.51	-8.0 mg/dL Standard Error 4.33	—	—
Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=93, Col N=98	-0.4 mg/dL Standard Error 4.28	-8.6 mg/dL Standard Error 4.19	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=90 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=95 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-4.9 mg/dL Standard Error 4.65	-6.3 mg/dL Standard Error 4.65	—	—
Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=98, Col N=98	-4.2 mg/dL Standard Error 4.40	-6.1 mg/dL Standard Error 4.46	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=84 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=91 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-8.563 uIU/mL Standard Error 6.6122	-15.472 uIU/mL Standard Error 6.4814	—	—
Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=92, Col N=94	-9.784 uIU/mL Standard Error 6.2865	-14.954 uIU/mL Standard Error 6.2745	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=85 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=93 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-0.447 ng/mL Standard Error 0.3527	-0.598 ng/mL Standard Error 0.3449	—	—
Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=93, Col N=96	-0.581 ng/mL Standard Error 0.3374	-0.551 ng/mL Standard Error 0.3359	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=94 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=89 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects Baseline to 8 Weeks	6.4 Percent of participants	29.2 Percent of participants	—	—
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects Baseline to 16 Weeks: Pla N=88, Col N=86	10.2 Percent of participants	29.1 Percent of participants	—	—
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects Baseline to 16 Weeks LOCF: Pla N=100, Col N=94	11.0 Percent of participants	28.7 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 8, and 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=98 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=98 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects Baseline to 8 Weeks	2.0 Percent of participants	11.2 Percent of participants	—	—
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects Baseline to 16 Weeks: Pla N=92, Col N=95	3.3 Percent of participants	7.4 Percent of participants	—	—
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects Baseline to 16 Weeks LOCF: Pla N=104, Col N=103	2.9 Percent of participants	6.8 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=92 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=96 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	-2.56 lb Standard Error 0.823	-3.24 lb Standard Error 0.832	—	—
Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks LOCF: Pla N=103, Col N=101	-2.63 lb Standard Error 0.758	-3.25 lb Standard Error 0.779	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=92 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=96 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks	0.0059 Change in Ratio Standard Error 0.00477	-0.0058 Change in Ratio Standard Error 0.00480	—	—
Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks Baseline to 16 Weeks: Pla N=103, Col N=101	0.0051 Change in Ratio Standard Error 0.00437	-0.0061 Change in Ratio Standard Error 0.00447	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=84 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=93 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 16 Weeks	-5.26 mg/dL*hr Standard Error 6.109	-8.27 mg/dL*hr Standard Error 5.878	—	—
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 Baseline to 16 Weeks: Pla N=92, Col N=96	-4.40 mg/dL*hr Standard Error 5.791	-9.20 mg/dL*hr Standard Error 5.685	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=57 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=67 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 16 Weeks	42.1 Percent of participants	37.3 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=61, Col N=69	41.0 Percent of participants	37.7 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12, and 16 Weeks

Population: 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

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=34 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=26 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 4 Weeks	38.2 Percent of participants	57.7 Percent of participants	—	—
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 Baseline to 8 Weeks: Pla N=34, Col N=26	50.0 Percent of participants	42.3 Percent of participants	—	—
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 Baseline to 12 Weeks: Pla N=34, Col N=26	55.9 Percent of participants	53.8 Percent of participants	—	—
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 Baseline to 16 Weeks: Pla N=32, Col N=25	56.3 Percent of participants	44.0 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=36, Col N=29	55.6 Percent of participants	48.3 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 4, 8, 12 and 16 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=69 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=63 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 4 Weeks	7.2 Percent of participants	39.7 Percent of participants	—	—
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 Baseline to 8 Weeks: Pla N=68, Col N=64	22.1 Percent of participants	29.7 Percent of participants	—	—
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 Baseline to 12 Weeks: Pla N=66, Col N=65	16.7 Percent of participants	33.8 Percent of participants	—	—
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 Baseline to 16 Weeks: Pla N=62, Col N=64	27.4 Percent of participants	40.6 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=73, Col N=68	23.3 Percent of participants	39.7 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=65 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=72 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 16 Weeks	36.9 Percent of participants	30.6 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=69, Col N=75	36.2 Percent of participants	32.0 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=69 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=60 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 16 Weeks	13.0 Percent of participants	21.7 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=78, Col N=65	12.8 Percent of participants	20.8 Percent of participants	—	—

SECONDARY outcome

Timeframe: Baseline to 16 Weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Type 2 Diabetes Group:Placebo+Metformin n=79 Participants 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.	Type 2 Diabetes Group:Colesevelam+Metformin n=81 Participants 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.	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.	Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) 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.
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 Baseline to 16 Weeks	10.1 Percent of participants	11.1 Percent of participants	—	—
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 Baseline to 16 Weeks LOCF: Pla N=87, Col N=84	10.3 Percent of participants	10.7 Percent of participants	—	—

Adverse Events

Type 2 Diabetes Group: Placebo + Metformin

Serious events: 1 serious events

Other events: 97 other events

Deaths: 0 deaths

Type 2 Diabetes Group: Colesevelam + Metformin

Serious events: 2 serious events

Other events: 97 other events

Deaths: 0 deaths

Pre-diabetic Group: Placebo

Serious events: 2 serious events

Other events: 63 other events

Deaths: 0 deaths

Pre-diabetic Group: Colesevelam

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Type 2 Diabetes Group: Placebo + Metformin n=141 participants at risk This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.	Type 2 Diabetes Group: Colesevelam + Metformin n=141 participants at risk；n=145 participants at risk This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.	Pre-diabetic Group: Placebo n=108 participants at risk This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.	Pre-diabetic Group: Colesevelam n=107 participants at risk This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
General disorders Chest pain	0.00% 0/141 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.69% 1/145 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/108 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/107 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/141 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/145 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.93% 1/108 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/107 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.
Cardiac disorders Coronary artery stenosis	0.71% 1/141 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/145 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/108 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/107 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.
Reproductive system and breast disorders Cystocele	0.00% 0/141 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/145 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.93% 1/108 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/107 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/141 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/145 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/108 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.93% 1/107 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma	0.00% 0/141 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.69% 1/145 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/108 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/107 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.
Reproductive system and breast disorders Polycystic Ovaries	0.00% 0/141 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/145 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.00% 0/108 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.	0.93% 1/107 • Adverse events were collected from the signing of the informed consent form until the end of the study + a follow up period (until the AE resolved or stabilized). This period of time equals about 17.5 weeks. AEs were noted by investigator or reported by subject. Nature, duration, remedial action, and severity of AE were recorded. Lab abnormalities were AEs if they needed intervention, further investigation, led to a change in medication, or were part of a larger disease process. Only 107 in the prediabetes colesevelam group because 1 did not take drug.

Other adverse events

Additional Information

John Raia, Senior Director Professional Affairs

Daiichi Sankyo, Inc.

Phone: (973) 944-2683

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The following language is employed: "If identified by DSI, any of DSI's confidential information as defined herein shall be deleted...Nothing in this publication section shall be taken as giving DSI and right of editorial control over any publication prepared by the Study Site."
Publication restrictions are in place

Restriction type: OTHER