Hypercholesterolemia, Pre-diabetes, Type 2 Diabetes Mellitus
Conditions
Keywords
Colesevelam, Type 2 Diabetes Mellitus, Pre-diabetes, Metformin
Brief summary
This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be be enrolled. Qualified subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or metformin HCl plus placebo matching colesevelam HCl. Qualified pre-diabetic subjects will be randomized 1:1 to receive colesevelam HCl or matching placebo.
Interventions
DRUGMetformin HCl and Colesevelam Placebo
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
DRUGMetformin HCl tablets and Colesevelam tablets
One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
DRUGColesevelam placebo
Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
DRUGColesevelam
Six colesevelam 625 mg tablets will be given once a day for 16 weeks.
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 79 years, inclusive. * HbA1C in the range of greater than or equal to 6.5 percent to small than or equal to 10.0 percent, to be enrolled in the T2DM cohort. * 2-hour post 75 g OGTT glucose levels in the range of: * greater than or equal to 200 mg/dL to be enrolled in the T2DM cohort, or * greater than or equal to 140 to 200 mg/dL to be enrolled in the pre-diabetes cohort. * FPG levels in the range of: * greater than or equal to 126 mg/dL to be enrolled in the T2DM cohort, or * greater than or equal to 110 to smaller than or equal to 125 mg/dL to be enrolled in the pre-diabetes cohort. * LDL-C levels greater than or equal to 100 mg/dL. * Drug-naïve, defined as having never received treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening visit. * Previous diagnosis of: * T2DM or prediabetes, to be enrolled in the respective cohorts, or * CHD, CVD, and/or primary hypercholesterolemia + BMI greater than or equal to 25 mg/kg2 to be screened for T2DM or pre-diabetes. * Understanding of the study procedures and agreement to participate in the study by giving written informed consent at screening visit. * Women may be enrolled if all 3 of the following criteria (in addition to the above criteria)are met: * They are not pregnant (women of childbearing potential must have a negative serum pregnancy test \[serum beta human chorionic gonadotropin )\] at screening visit); * They are not breast-feeding; and * They do not plan to become pregnant during the study. * In addition to all of the above criteria, women must also meet 1 of the following 3 criteria to be enrolled: * They have been post-menopausal for at least 1 year; or * They are of childbearing potential and will practice 1 of the following methods of birth control throughout the study: oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide. Methods of contraception that are not acceptable are partner's use of condoms or partner's vasectomy.
Exclusion criteria
* History of type 1 diabetes and/or history of acute or chronic metabolic acidosis, including diabetic ketoacidosis. * History of chronic (requiring daily for greater than 2 months) use of insulin therapy, except for the treatment of gestational diabetes. * Current or prior (within the past 3 months) treatment with an oral antidiabetic drug. * Current or prior (within the past 3 months) treatment with colesevelam HCl (WelChol), colestipol, colestimide, or cholestyramine. * History of dysphagia, swallowing disorders, or intestinal motility disorder. * Any serious disorder, including pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data. * Acute coronary syndrome (eg, myocardial infarction or unstable angina), coronary intervention (coronary artery bypass graft or percutaneous transluminal coronary angioplasty or similar procedure), congestive heart failure (requiring pharmacological treatment), or transient ischemic attack within 3 months of screening visit. * History of pancreatitis. * History of acquired immune deficiency syndrome or human immunodeficiency virus. * History of drug or alcohol abuse within the past 2 years. * Hospitalization for any cause within 14 days prior to screening visit. * History of an allergic or toxic response to colesevelam HCl or any of its components. * Known hypersensitivity to metformin HCl. * Serum TG greater than or equal to 500 mg/dL. * Body mass index (BMI) greater than 40 kg/m2 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects. | Baseline to 16 weeks |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 16 weeks | — |
| Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 16 weeks | — |
| Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | — |
| 30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | — |
| 1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | — |
| 2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | — |
| 2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 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 | — |
| 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, and 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, and 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, and 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, and 16 weeks | — |
| Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 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, and 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, and 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, and 16 weeks | — |
| Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 weeks | — |
| Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | — |
| Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 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 | These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary. |
| Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary. |
| 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, 8, 12, and 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, 8, 12 and 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 Weeks 8, and 16 | — |
| 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 Weeks 8, and 16 | — |
| Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | — |
| Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks | Baseline to 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 vs. 16 Weeks | — |
| Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects | Baseline to 16 Weeks | These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary. |
| 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 Week 16 | — |
| 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 | — |
| Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 Weeks | — |
| Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 Weeks | — |
| Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 Weeks | — |
| Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 Weeks | — |
| Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 Weeks | — |
| Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 Weeks | — |
| Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 Weeks | — |
| Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8, and 16 Weeks | — |
| Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline 16 Weeks | — |
| Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | — |
| Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | — |
| Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary. |
| Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 16 Weeks | — |
| Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 16 weeks | — |
| Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4, 8, 12, and 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 | — |
| Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 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 | — |
| Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 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 | — |
| Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects | Baseline to 8, and 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, and 16 Weeks | — |
| Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | — |
| Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | — |
| Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 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 | — |
| 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, 8, 12, and 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, 8, 12 and 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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, 8, 12, and 16 weeks | — |
Countries
Colombia, India, Mexico, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 141 |
| 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. | 145 |
| Pre-diabetic Group: Placebo This group received 6 colesevelam matching placebo tablets once per day for 16 weeks | 108 |
| Pre-diabetic Group: Colesevelam This group received 6 colesevelam tablets, 625mg, once per day for 16 weeks. | 108 |
| Total | 502 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 6 | 2 | 2 |
| Overall Study | Lost to Follow-up | 4 | 5 | 4 | 1 |
| Overall Study | Met discontinuation criteria | 1 | 0 | 1 | 1 |
| Overall Study | Other | 0 | 2 | 5 | 3 |
| Overall Study | Physician Decision | 1 | 1 | 0 | 0 |
| Overall Study | Required restricted medication | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 7 | 3 | 5 |
Baseline characteristics
| Characteristic | Total | Type 2 Diabetes Group: Colesevelam + Metformin | Type 2 Diabetes Group: Placebo + Metformin | Pre-diabetic Group: Placebo | Pre-diabetic Group: Colesevelam |
|---|---|---|---|---|---|
| Age Continuous | 53.3 years STANDARD_DEVIATION 10.81 | 52.7 years STANDARD_DEVIATION 11.46 | 53.9 years STANDARD_DEVIATION 10.11 | 55.7 years STANDARD_DEVIATION 11.14 | 53.3 years STANDARD_DEVIATION 12.27 |
| Body Mass Index | 30.19 kg/m squared STANDARD_DEVIATION 4.57 | 30.58 kg/m squared STANDARD_DEVIATION 4.669 | 29.78 kg/m squared STANDARD_DEVIATION 4.44 | 30.82 kg/m squared STANDARD_DEVIATION 4.18 | 30.93 kg/m squared STANDARD_DEVIATION 4.89 |
| Fasting glucose | 149.6 mg/dL STANDARD_DEVIATION 38.43 | 153.4 mg/dL STANDARD_DEVIATION 39.04 | 145.7 mg/dL STANDARD_DEVIATION 37.54 | 106.8 mg/dL STANDARD_DEVIATION 14.8 | 104.1 mg/dL STANDARD_DEVIATION 11.33 |
| Fasting insulin | 13.34 uIU/mL STANDARD_DEVIATION 12.66 | 13.86 uIU/mL STANDARD_DEVIATION 15.75 | 12.82 uIU/mL STANDARD_DEVIATION 8.44 | 11.03 uIU/mL STANDARD_DEVIATION 5.55 | 13.12 uIU/mL STANDARD_DEVIATION 8.75 |
| Glucose 2 hours after meal | 227.7 mg/dL STANDARD_DEVIATION 65.74 | 234.7 mg/dL STANDARD_DEVIATION 71.36 | 220.3 mg/dL STANDARD_DEVIATION 58.68 | 153.7 mg/dL STANDARD_DEVIATION 39.81 | 153.7 mg/dL STANDARD_DEVIATION 37.9 |
| Height | 161.5 cm STANDARD_DEVIATION 10.18 | 162.3 cm STANDARD_DEVIATION 9.67 | 160.6 cm STANDARD_DEVIATION 10.64 | 159.1 cm STANDARD_DEVIATION 9.95 | 160.8 cm STANDARD_DEVIATION 9.96 |
| Hemoglobin A1c | 7.65 Percent STANDARD_DEVIATION 1 | 7.76 Percent STANDARD_DEVIATION 1.04 | 7.53 Percent STANDARD_DEVIATION 0.94 | 6.07 Percent STANDARD_DEVIATION 0.45 | 6.02 Percent STANDARD_DEVIATION 0.46 |
| Low Density Lipoprotein Cholesterol | 132.2 mg/dL STANDARD_DEVIATION 25.07 | 129.1 mg/dL STANDARD_DEVIATION 23.08 | 135.5 mg/dL STANDARD_DEVIATION 26.66 | 136.8 mg/dL STANDARD_DEVIATION 28.48 | 132.8 mg/dL STANDARD_DEVIATION 23.88 |
| Previously diagnosed with neither diabetes nor pre-diabetes | 77 Participant | 15 Participant | 14 Participant | 26 Participant | 22 Participant |
| Previously diagnosed with pre-diabetes | 204 Participant | 21 Participant | 17 Participant | 81 Participant | 85 Participant |
| Previously diagnosed with type 2 diabetes | 221 Participant | 109 Participant | 110 Participant | 1 Participant | 1 Participant |
| Race/Ethnicity, Customized Asian | 91 Participants | 32 Participants | 30 Participants | 15 Participants | 14 Participants |
| Race/Ethnicity, Customized Black/African American | 6 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 339 Participants | 89 Participants | 90 Participants | 78 Participants | 82 Participants |
| Race/Ethnicity, Customized White | 66 Participants | 21 Participants | 20 Participants | 14 Participants | 11 Participants |
| Region of Enrollment Colombia | 124 participants | 26 participants | 25 participants | 36 participants | 37 participants |
| Region of Enrollment India | 90 participants | 31 participants | 30 participants | 15 participants | 14 participants |
| Region of Enrollment Mexico | 195 participants | 58 participants | 56 participants | 40 participants | 41 participants |
| Region of Enrollment United States | 93 participants | 30 participants | 30 participants | 17 participants | 16 participants |
| Sex: Female, Male Female | 310 Participants | 76 Participants | 85 Participants | 81 Participants | 68 Participants |
| Sex: Female, Male Male | 192 Participants | 69 Participants | 56 Participants | 27 Participants | 40 Participants |
| Weight | 79.08 kg STANDARD_DEVIATION 15.92 | 80.84 kg STANDARD_DEVIATION 15.53 | 77.26 kg STANDARD_DEVIATION 16.17 | 78.18 kg STANDARD_DEVIATION 13.76 | 80.63 kg STANDARD_DEVIATION 18.02 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 97 / 141 | 97 / 141 | 63 / 108 | 57 / 107 |
| serious Total, serious adverse events | 1 / 141 | 2 / 145 | 2 / 108 | 2 / 107 |
Outcome results
Primary
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) in Pre-Diabetic Subjects From Baseline to 16 Weeks | -13.89 Percentage of change in LDL-C | Standard Error 2.088 |
p-value: <0.000195% CI: [-21.07, -10.11]ANCOVA
Primary
Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change of Hemoglobin A1C (HbA1C) From Baseline to 16 Weeks When Given as Initial Therapy to Drug-naïve, Diabetic Subjects. | -1.09 Percentage of change of hemoglobin A1C | Standard Error 0.064 |
p-value: 0.003595% CI: [-0.44, -0.09]ANCOVA
Secondary
1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 1 Hour Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -41.9 mg/dL | Standard Error 3.88 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -39.1 mg/dL | Standard Error 3.94 |
Comparison: Baseline to 16 weeksp-value: 0.19595% CI: [-17.5, 3.6]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.158395% CI: [-18.3, 3]ANCOVA
Secondary
2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 2 Hour Post-Meal C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -0.102 ng/mL | Standard Error 0.2373 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.135 ng/mL | Standard Error 0.2374 |
Comparison: Baseline to 16 Weeksp-value: 0.516195% CI: [-0.437, 0.867]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.831995% CI: [-0.581, 0.722]ANCOVA
Secondary
2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -36.2 mg/dL | Standard Error 4.14 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 2 Hour Post-Meal Glucose Levels to in Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -38.14 mg/dL | Standard Error 4.02 |
Comparison: Baseline to 16 Weeksp-value: 0.366395% CI: [-16.1, 6]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.252495% CI: [-17.9, 4.7]ANCOVA
Secondary
2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 2 Hour Post-Meal Insulin Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -10.551 uIU/mL | Standard Error 3.237 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -10.156 uIU/mL | Standard Error 3.4399 |
Comparison: Baseline to 16 Weeksp-value: 0.815895% CI: [-7.828, 9.929]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.743395% CI: [-10.966, 7.836]ANCOVA
Secondary
30 Minute Post-Meal Glucose Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 3.43 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -30.4 mg/dL | Standard Error 3.45 |
Comparison: Baseline to 16 weeksp-value: 0.993395% CI: [-9.3, 9.4]ANCOVA
Comparison: Baseline to 16 weeks LOCFp-value: 0.820395% CI: [-10.5, 8.3]ANCOVA
Secondary
Area Under the Curve for Plasma Glucose From 0 to 120 Minutes During the Oral Glucose Tolerance Tests in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -8.27 mg/dL*hr | Standard Error 5.878 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -9.20 mg/dL*hr | Standard Error 5.685 |
Comparison: Baseline to 16 Weeksp-value: 0.705195% CI: [-18.64, 12.64]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.526795% CI: [-19.72, 10.13]ANCOVA
Secondary
Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -2.56 lb | Standard Error 0.823 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -3.24 lb | Standard Error 0.832 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in Body Weight in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks LOCF: Pla N=103, Col N=101 | -3.25 lb | Standard Error 0.779 |
Comparison: Baseline to 16 Weeksp-value: 0.535395% CI: [-2.84, 1.48]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.547595% CI: [-2.64, 1.4]ANCOVA
Secondary
Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in Body Weight When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -4.91 lb | Standard Error 0.552 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -4.56 lb | Standard Error 0.519 |
Comparison: Baseline to 16 Weeksp-value: 0.795995% CI: [-1.32, 1.72]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.837195% CI: [-1.28, 1.57]ANCOVA
Secondary
Change in Plasma Glucose Area Under the Curve (0 to 120 Minutes) From the Baseline Glucose Tolerance Test (GTT) to the 16 Week GTT
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 6.46 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -77.56 mg/dL*hr | Standard Error 6.266 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -71.88 mg/dL*hr | Standard Error 6.524 |
Comparison: Baseline to 16 Weeksp-value: 0.228995% CI: [-27.53, 6.62]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.199795% CI: [-29.22, 6.14]ANCOVA
Secondary
Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Calculated High Density Lipoprotein Cholesterol When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | 5.8 mg/dL | Standard Error 0.62 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 5.6 mg/dL | Standard Error 0.6 |
Comparison: Baseline to 16 Weeksp-value: 0.003395% CI: [0.9, 4.3]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.000895% CI: [1.2, 4.4]ANCOVA
Secondary
Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Calculated Total Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | 17.6 mg/dL | Standard Error 6.43 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 18.2 mg/dL | Standard Error 5.93 |
Comparison: Baseline to 16 Weeksp-value: 0.003695% CI: [8.6, 43.5]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.00195% CI: [11.2, 43.3]ANCOVA
Secondary
Change in the Calculated Very Low Density Lipoprotein Triglycerides When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 22.4 mg/dL | Standard Error 6.34 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 22.9 mg/dL | Standard Error 5.86 |
Comparison: Baseline to 16 Weeksp-value: 0.000895% CI: [12.5, 47]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.000295% CI: [14.9, 46.6]ANCOVA
Secondary
Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 0.16 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium HDL Particles | 0.50 nmol/L | Standard Error 0.274 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small VLDL Particles | -4.00 nmol/L | Standard Error 1.532 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -303.3 nmol/L | Standard Error 27.05 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Large HDL Particles | 1.09 nmol/L | Standard Error 0.161 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small LDL Particles | -256.7 nmol/L | Standard Error 31.63 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small HDL Particles | 0.74 nmol/L | Standard Error 0.384 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Intermediate Density Lipoprotein Particles | -21.3 nmol/L | Standard Error 4.24 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Large LDL Particles | -25.5 nmol/L | Standard Error 15.69 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium Small LDL Particles | -48.2 nmol/L | Standard Error 7.15 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium VLDL Particles | 4.84 nmol/L | Standard Error 1.492 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | VLDL Chylomicron Particles | 1.73 nmol/L | Standard Error 0.552 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 2.41 nmol/L | Standard Error 0.351 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Very Small LDL Particles | -208.7 nmol/L | Standard Error 24.97 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 2.81 nmol/L | Standard Error 2.355 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small VLDL Particles | -0.83 nmol/L | Standard Error 1.413 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 | -3.71 nmol/L | Standard Error 2.167 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 0.507 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Large LDL Particles | 45.1 nmol/L | Standard Error 14.6 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Very Small LDL Particles | -115.3 nmol/L | Standard Error 23.31 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Large HDL Particles | 0.55 nmol/L | Standard Error 0.153 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium HDL Particles | -0.26 nmol/L | Standard Error 0.259 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium VLDL Particles | -2.28 nmol/L | Standard Error 1.383 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 | -109.5 nmol/L | Standard Error 25.49 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Intermediate Density Lipoprotein Particles | -8.9 nmol/L | Standard Error 4.03 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small LDL Particles | -145.9 nmol/L | Standard Error 29.52 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium Small LDL Particles | -30.8 nmol/L | Standard Error 6.72 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 | 1.34 nmol/L | Standard Error 0.332 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small HDL Particles | 1.05 nmol/L | Standard Error 0.362 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium VLDL Particles | 4.85 nmol/L | Standard Error 1.396 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | 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 | 2.68 nmol/L | Standard Error 2.188 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | VLDL Chylomicron Particles | 1.76 nmol/L | Standard Error 0.511 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium Small LDL Particles | -46.2 nmol/L | Standard Error 6.78 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Large HDL Particles | 1.00 nmol/L | Standard Error 0.155 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Very Small LDL Particles | -206.6 nmol/L | Standard Error 23.57 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | 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 | 2.35 nmol/L | Standard Error 0.335 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Large LDL Particles | -24.2 nmol/L | Standard Error 14.73 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small HDL Particles | 0.70 nmol/L | Standard Error 0.366 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Medium HDL Particles | 0.59 nmol/L | Standard Error 0.261 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Intermediate Density Lipoprotein Particles | -19.6 nmol/L | Standard Error 4.08 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | 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 | -295.5 nmol/L | Standard Error 25.77 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small VLDL Particles | -4.06 nmol/L | Standard Error 1.426 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Levels of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Small LDL Particles | -252.7 nmol/L | Standard Error 29.84 |
Comparison: Small VLDL Particlesp-value: 0.100795% CI: [-7.1, 0.63]ANCOVA
Comparison: Total Very Low Density Lipoprotein (VLDL) Particlesp-value: 0.036395% CI: [0.44, 13.24]ANCOVA
Comparison: Total Very Low Density Lipoprotein (VLDL) Particlesp-value: 0.034795% CI: [0.46, 12.31]ANCOVA
Comparison: VLDL Chylomicron Particlesp-value: 0.002895% CI: [0.8, 3.81]ANCOVA
Comparison: VLDL Chylomicron Particlesp-value: 0.00195% CI: [0.96, 3.73]ANCOVA
Comparison: Medium VLDL Particlesp-value: 0.000695% CI: [3.1, 11.21]ANCOVA
Comparison: Medium VLDL Particlesp-value: 0.000395% CI: [3.35, 10.91]ANCOVA
Comparison: Small VLDL Particlesp-value: 0.17595% CI: [-7.04, 1.29]ANCOVA
Comparison: Total Low Density Lipoprotein (LDL) Particlesp-value: <0.000195% CI: [-272.9, -125.8]ANCOVA
Comparison: Total Low Density Lipoprotein (LDL) Particlesp-value: 0.000195% CI: [-255.9, -116.3]ANCOVA
Comparison: Intermediate Density Lipoprotein Particlesp-value: 0.046695% CI: [-23.3, -0.2]ANCOVA
Comparison: Intermediate Density Lipoprotein Particlesp-value: 0.05795% CI: [-21.8, 0.3]ANCOVA
Comparison: Large LDL Particlesp-value: 0.000495% CI: [-120.3, -35]ANCOVA
Comparison: Large LDL Particlesp-value: 0.000795% CI: [-109.2, -29.3]ANCOVA
Comparison: Small LDL Particlesp-value: 0.012495% CI: [-195.8, -23.9]ANCOVA
Comparison: Small LDL Particlesp-value: 0.009895% CI: [-187.6, -26]ANCOVA
Comparison: Medium Small LDL Particlesp-value: 0.10295% CI: [-35.6, 3.2]ANCOVA
Comparison: Medium Small LDL Particlesp-value: 0.099795% CI: [-33.8, 3]ANCOVA
Comparison: Very Small LDL Particlesp-value: 0.006995% CI: [-161.6, -25.9]ANCOVA
Comparison: Very Small LDL Particlesp-value: 0.005295% CI: [-155.2, -27.5]ANCOVA
Comparison: Total High Density Lipoprotein (HDL) Particlesp-value: 0.052495% CI: [-0.01, 1.9]ANCOVA
Comparison: Total High Density Lipoprotein (HDL) Particlesp-value: 0.030195% CI: [0.1, 1.91]ANCOVA
Comparison: Large HDL Particlesp-value: 0.041695% CI: [0.02, 0.89]ANCOVA
Comparison: Large HDL Particlesp-value: 0.033395% CI: [0.04, 0.88]ANCOVA
Comparison: Medium HDL Particlesp-value: 0.069395% CI: [-0.05, 1.44]ANCOVA
Comparison: Medium HDL Particlesp-value: 0.018795% CI: [0.14, 1.56]ANCOVA
Comparison: Small HDL Particlesp-value: 0.576595% CI: [-1.34, 0.75]ANCOVA
Comparison: Small HDL Particlesp-value: 0.476295% CI: [-1.35, 0.63]ANCOVA
Secondary
Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 1.41 nm | Standard Error 0.866 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | High Density Lipoprotein Particles | 0.17 nm | Standard Error 0.023 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Low Density Lipoprotein Particles | 0.15 nm | Standard Error 0.053 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Low Density Lipoprotein Particles | 0.19 nm | Standard Error 0.049 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 | -1.02 nm | Standard Error 0.796 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 0.021 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | 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 | 1.73 nm | Standard Error 0.804 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | High Density Lipoprotein Particles | 0.17 nm | Standard Error 0.022 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change in the Size of Various Lipoprotein Particles When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Low Density Lipoprotein Particles | 0.15 nm | Standard Error 0.05 |
Comparison: Very Low Density Lipoprotein Particlesp-value: 0.065295% CI: [-0.14, 4.57]ANCOVA
Comparison: Very Low Density Lipoprotein Particlesp-value: 0.013795% CI: [0.57, 4.92]ANCOVA
Comparison: Low Density Lipoprotien Particlesp-value: 0.472695% CI: [-0.2, 0.09]ANCOVA
Comparison: Low Density Lipoprotein Particlesp-value: 0.571595% CI: [-0.17, 0.1]ANCOVA
Comparison: High Density Lipoprotein Particlesp-value: 0.008395% CI: [0.02, 0.15]ANCOVA
Comparison: High Density Lipoprotein Particlesp-value: 0.002295% CI: [0.03, 0.15]ANCOVA
Secondary
Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in Waist-to-Hip Ratio in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -0.0058 Change in Ratio | Standard Error 0.0048 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.0061 Change in Ratio | Standard Error 0.00447 |
Comparison: Baseline to 16 Weeksp-value: 0.067895% CI: [-0.0241, 0.0009]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.058595% CI: [-0.0228, 0.0004]ANCOVA
Secondary
Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change in Waist-to-Hip Ratio When Given to Drug-Naive Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -0.0067 Ratio | Standard Error 0.00323 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.0065 Ratio | Standard Error 0.00304 |
Comparison: Baseline to 16 Weeksp-value: 0.458495% CI: [-0.0122, 0.0055]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.403995% CI: [-0.0118, 0.0048]ANCOVA
Secondary
Change of C-Peptide Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.598 ng/mL | Standard Error 0.3449 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.551 ng/mL | Standard Error 0.3359 |
Comparison: Baseline to 16 Weeksp-value: 0.744795% CI: [-1.068, 0.765]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.947695% CI: [-0.853, 0.911]ANCOVA
Secondary
Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: Baseline to 16 Weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change of Fasting C-peptide Levels in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -0.050 ng/mL | Standard Error 0.1132 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.057 ng/mL | Standard Error 0.1059 |
Comparison: Baseline to 16 Weeksp-value: 0.55395% CI: [-0.385, 0.207]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.455495% CI: [-0.383, 0.172]ANCOVA
Secondary
Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change of Glucose Levels 1 Hour Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -8.0 mg/dL | Standard Error 4.33 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -8.6 mg/dL | Standard Error 4.19 |
Comparison: Baseline to 16 Weeksp-value: 0.23395% CI: [-18.5, 4.5]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.141295% CI: [-19.2, 2.8]ANCOVA
Secondary
Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 4.4 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change of Glucose Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -6.3 mg/dL | Standard Error 4.65 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -6.1 mg/dL | Standard Error 4.46 |
Comparison: Baseline to 16 Weeksp-value: 0.819295% CI: [-13.7, 10.8]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.751395% CI: [-13.5, 9.7]ANCOVA
Secondary
Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 3.6 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change of Glucose Levels 30 Minutes Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -1.8 mg/dL | Standard Error 3.71 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -2.5 mg/dL | Standard Error 3.58 |
Comparison: Baseline to 16 Weeksp-value: 0.858395% CI: [-10.7, 8.9]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.797595% CI: [-10.5, 8.1]ANCOVA
Secondary
Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change of Insulin Levels 2 Hours Post Oral Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -15.472 uIU/mL | Standard Error 6.4814 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -14.954 uIU/mL | Standard Error 6.2745 |
Comparison: Baseline to 16 Weeksp-value: 0.430195% CI: [-24.156, 10.336]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.536995% CI: [-21.661, 11.321]ANCOVA
Secondary
Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 5.7 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Changes in Calculated Total Triglycerides | 19.4 mg/dL | Standard Error 5.91 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Changes in Calculated High Density Lipoprotein -C | 2.9 mg/dL | Standard Error 0.74 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Changes: Calculated Very Low Density Triglycerides | 21.7 mg/dL | Standard Error 5.64 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Changes: Calculated Very Low Density Triglycerides | -5.9 mg/dL | Standard Error 5.34 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Changes in Calculated Total Triglycerides | -6.4 mg/dL | Standard Error 5.6 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 0.69 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Changes in Calculated Total Triglycerides | 18.0 mg/dL | Standard Error 5.62 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Changes in Calculated High Density Lipoprotein -C | 2.9 mg/dL | Standard Error 0.69 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Change of Various Calculated Lipid Parameters in Pre-Diabetic Subjects From Baseline to 16 Weeks | Changes: Calculated Very Low Density Triglycerides | 20.6 mg/dL | Standard Error 5.36 |
Comparison: Changes in Calculated Total Triglyceridesp-value: 0.002295% CI: [8.9, 39.9]ANCOVA
Comparison: Changes in Calculated Total Triglyceridesp-value: 0.001395% CI: [9.6, 39.1]ANCOVA
Comparison: Changes: Calculated Very Low Density Triglyceridesp-value: 0.000695% CI: [11.5, 41]ANCOVA
Comparison: Changes: Calculated Very Low Density Triglyceridesp-value: 0.000395% CI: [12.5, 40.6]ANCOVA
Comparison: Changes in Calculated High Density Lipoprotein-Cholesterolp-value: 0.125795% CI: [-0.4, 3.5]ANCOVA
Comparison: Changes in Calculated High Density Lipoprotein-Cholesterolp-value: 0.105495% CI: [-0.3, 3.3]ANCOVA
Secondary
Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 0.065 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Fasting C-Peptide Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -0.449 ng/mL | Standard Error 0.0683 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.426 ng/mL | Standard Error 0.0644 |
Comparison: Baseline to 16 weeksp-value: 0.107895% CI: [-0.34, 0.034]ANCOVA
Comparison: Baseline to 16 weeks (LOCF)p-value: 0.114695% CI: [-0.317, 0.035]ANCOVA
Secondary
Fasting Insulin When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -2.637 uIU/mL | Standard Error 0.6644 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -2.427 uIU/mL | Standard Error 0.7219 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -3.007 uIU/mL | Standard Error 0.5376 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -3.708 uIU/mL | Standard Error 0.5048 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -2.802 uIU/mL | Standard Error 0.7217 |
Comparison: Baseline to 4 weeksp-value: 0.760695% CI: [-2.259, 1.653]ANCOVA
Comparison: Baseline to 8 weeksp-value: 0.178295% CI: [-2.477, 0.447]ANCOVA
Comparison: Baseline to 12 weeksp-value: 0.033295% CI: [-2.887, -0.121]ANCOVA
Comparison: Baseline to 16 weeksp-value: 0.86195% CI: [-1.805, 2.158]ANCOVA
Comparison: Baseline to 16 weeks (LOCF)p-value: 0.819695% CI: [-1.599, 2.019]ANCOVA
Secondary
Fasting Plasma Glucose When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -28.0 mg/dL | Standard Error 2.18 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -24.0 mg/dL | Standard Error 2.3 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -27.6 mg/dL | Standard Error 1.94 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -28.4 mg/dL | Standard Error 2.18 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -30.5 mg/dL | Standard Error 2.16 |
Comparison: Baseline to 4 Weeksp-value: 0.111295% CI: [-11.3, 1.2]ANCOVA
Comparison: Baseline to 8 Weeksp-value: 0.216795% CI: [-8.6, 2]ANCOVA
Comparison: Baseline to 12 weeksp-value: 0.726995% CI: [-7, 4.9]ANCOVA
Comparison: Baseline to 16 weeksp-value: 0.406395% CI: [-8.4, 3.4]ANCOVA
Comparison: Baseline to 16 weeks (LOCF)p-value: 0.490995% CI: [-8, 3.9]ANCOVA
Secondary
Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Very Small LDL Particles | -78.3 nmol/L | Standard Error 35.6 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large LDL Particles | 91.3 nmol/L | Standard Error 29.2 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium Small LDL Particles | -28.2 nmol/L | Standard Error 8.95 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium HDL Particles | -0.03 nmol/L | Standard Error 0.334 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total Very Low Density Lipoprotein (VLDL) Particle | 1.92 nmol/L | Standard Error 3.337 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large VLDL Chylomicron Particles | 1.64 nmol/L | Standard Error 0.453 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium VLDL Particles | 6.59 nmol/L | Standard Error 1.986 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small VLDL Particles | -6.34 nmol/L | Standard Error 1.951 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total Low Density Lipoprotein (LDL) Particles | -135.2 nmol/L | Standard Error 37.83 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Intermediate Density Lipoprotein (LDL) Particles | -15.3 nmol/L | Standard Error 5.69 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large LDL Particles | 27.6 nmol/L | Standard Error 28.99 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small LDL Particles | -148.6 nmol/L | Standard Error 43.79 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Very Small LDL Particles | -120.3 nmol/L | Standard Error 35.32 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total High Density Lipoprotein (HDL) Particles | 0.28 nmol/L | Standard Error 0.452 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large HDL Particles | 1.09 nmol/L | Standard Error 0.21 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small HDL Particles | -0.77 nmol/L | Standard Error 0.471 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Intermediate Density Lipoprotein (LDL) Particles | -14.7 nmol/L | Standard Error 5.37 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large HDL Particles | 0.53 nmol/L | Standard Error 0.197 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Very Small LDL Particles | -81.0 nmol/L | Standard Error 33.68 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small HDL Particles | 0.10 nmol/L | Standard Error 0.45 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium HDL Particles | -0.24 nmol/L | Standard Error 0.31 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small LDL Particles | -102.5 nmol/L | Standard Error 41.72 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large LDL Particles | 91.3 nmol/L | Standard Error 26.79 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small VLDL Particles | 0.52 nmol/L | Standard Error 1.837 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total Very Low Density Lipoprotein (VLDL) Particle | 0.72 nmol/L | Standard Error 3.132 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium VLDL Particles | 1.15 nmol/L | Standard Error 1.89 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total High Density Lipoprotein (HDL) Particles | 0.38 nmol/L | Standard Error 0.428 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total Low Density Lipoprotein (LDL) Particles | -25.7 nmol/L | Standard Error 35.97 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium Small LDL Particles | -21.5 nmol/L | Standard Error 8.48 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large VLDL Chylomicron Particles | -0.86 nmol/L | Standard Error 0.424 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large VLDL Chylomicron Particles | 1.53 nmol/L | Standard Error 0.426 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Intermediate Density Lipoprotein (LDL) Particles | -17.0 nmol/L | Standard Error 5.41 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large HDL Particles | 1.10 nmol/L | Standard Error 0.198 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Large LDL Particles | 27.5 nmol/L | Standard Error 26.93 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total Very Low Density Lipoprotein (VLDL) Particle | 2.25 nmol/L | Standard Error 3.149 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small LDL Particles | -149.4 nmol/L | Standard Error 41.94 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium Small LDL Particles | -28.3 nmol/L | Standard Error 8.52 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium HDL Particles | -0.05 nmol/L | Standard Error 0.312 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Very Small LDL Particles | -121.0 nmol/L | Standard Error 33.86 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Medium VLDL Particles | 6.40 nmol/L | Standard Error 1.895 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small HDL Particles | -0.75 nmol/L | Standard Error 0.453 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Small VLDL Particles | -5.73 nmol/L | Standard Error 1.844 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total Low Density Lipoprotein (LDL) Particles | -138.4 nmol/L | Standard Error 36.15 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Level of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Total High Density Lipoprotein (HDL) Particles | 0.28 nmol/L | Standard Error 0.43 |
Comparison: Total VLDL Particlesp-value: 0.983895% CI: [-8.66, 8.84]ANCOVA
Comparison: Total VLDL Particlesp-value: 0.715795% CI: [-6.73, 9.79]ANCOVA
Comparison: Large VLDL Chylomicron Particlesp-value: <0.000195% CI: [1.25, 3.63]ANCOVA
Comparison: Large VLDL Chylomicron Particlesp-value: <0.000195% CI: [1.27, 3.51]ANCOVA
Comparison: Medium VLDL Chylomicron Particlesp-value: 0.057795% CI: [-0.17, 10.24]ANCOVA
Comparison: Medium VLDL Chylomicron Particlesp-value: 0.03995% CI: [0.27, 10.22]ANCOVA
Comparison: Small VLDL Particlesp-value: 0.004495% CI: [-12.61, -2.37]ANCOVA
Comparison: Small VLDL Particlesp-value: 0.011895% CI: [-11.09, -1.4]ANCOVA
Comparison: Total Low Density Lipoprotein (LDL) Particlesp-value: 0.029395% CI: [-209.9, -11.3]ANCOVA
Comparison: Total Low Density Lipoprotein (LDL) Particlesp-value: 0.020295% CI: [-207.6, -17.8]ANCOVA
Comparison: Intermediate Density Lipoprotein (LDL) Particlesp-value: 0.962995% CI: [-15.2, 14.5]ANCOVA
Comparison: Intermediate Density Lipoprotein (LDL) Particlesp-value: 0.748595% CI: [-16.5, 11.9]ANCOVA
Comparison: Large LDL Particlesp-value: 0.100795% CI: [-139.7, 12.5]ANCOVA
Comparison: Large LDL Particlesp-value: 0.076895% CI: [-134.6, 6.9]ANCOVA
Comparison: Small LDL Particlesp-value: 0.414395% CI: [-162.7, 67.3]ANCOVA
Comparison: Small LDL Particlesp-value: 0.40295% CI: [-157.1, 63.3]ANCOVA
Comparison: Medium Small LDL Particlesp-value: 0.637895% CI: [-29.1, 17.9]ANCOVA
Comparison: Medium Small LDL Particlesp-value: 0.552895% CI: [-29.1, 15.6]ANCOVA
Comparison: Very Small LDL Particlesp-value: 0.37395% CI: [-134.8, 50.8]ANCOVA
Comparison: Very Small LDL Particlesp-value: 0.376495% CI: [-129, 49]ANCOVA
Comparison: Total High Density Lipoprotein (HDL) Particlesp-value: 0.980795% CI: [-1.2, 1.17]ANCOVA
Comparison: Total High Density Lipoprotein (HDL) Particlesp-value: 0.861595% CI: [-1.23, 1.03]ANCOVA
Comparison: Large HDL Particlesp-value: 0.036495% CI: [0.04, 1.14]ANCOVA
Comparison: Large HDL Particlesp-value: 0.03495% CI: [0.04, 1.08]ANCOVA
Comparison: Medium HDL Particlesp-value: 0.658795% CI: [-0.68, 1.07]ANCOVA
Comparison: Medium HDL Particlesp-value: 0.655495% CI: [-0.63, 1]ANCOVA
Comparison: Small HDL Particlesp-value: 0.195795% CI: [-2.06, 0.42]ANCOVA
Comparison: Small HDL Particlesp-value: 0.162295% CI: [-2.03, 0.34]ANCOVA
Secondary
Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Very Low Density Lipoprotein Particles | 4.15 nm | Standard Error 0.948 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | High Density Lipoprotein Particles | 0.15 nm | Standard Error 0.026 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Low Density Lipoprotein Particles | 0.11 nm | Standard Error 0.068 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Low Density Lipoprotein Particles | 0.23 nm | Standard Error 0.064 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Very Low Density Lipoprotein Particles | -1.43 nm | Standard Error 0.877 |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | High Density Lipoprotein Particles | 0.05 nm | Standard Error 0.024 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Very Low Density Lipoprotein Particles | 3.89 nm | Standard Error 0.883 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | High Density Lipoprotein Particles | 0.15 nm | Standard Error 0.024 |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | Particle Size of Various Lipoprotein Particles in Pre-Diabetic Subjects From Baseline to 16 Weeks | Low Density Lipoprotein Particles | 0.12 nm | Standard Error 0.065 |
Comparison: Very Low Density Lipoprotein Particlesp-value: <0.000195% CI: [3.51, 8.48]ANCOVA
Comparison: Very Low Density Lipoprotein Particlesp-value: <0.000195% CI: [3, 7.63]ANCOVA
Comparison: Low Density Lipoprotein Particlesp-value: 0.174295% CI: [-0.3, 0.05]ANCOVA
Comparison: Low Density Lipoprotein Particlesp-value: 0.18795% CI: [-0.28, 0.06]ANCOVA
Comparison: High Density Lipoprotein Particlesp-value: 0.006395% CI: [0.03, 0.16]ANCOVA
Comparison: High Density Lipoprotein Particlesp-value: 0.00295% CI: [0.04, 0.16]ANCOVA
Secondary
Percent Achievement of <100 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 100 mg/dL From Baseline to 4, 8, 12 and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 39.7 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 39.7 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 29.7 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 33.8 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 40.6 Percent of participants |
Comparison: Baseline to 4 Weeksp-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Baseline to 8 Weeksp-value: 0.4058Cochran-Mantel-Haenszel
Comparison: Baseline to 12 Weeksp-value: 0.0254Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.149995% CI: [0.74, 3.55]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.04295% CI: [0.97, 4.45]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.224Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.0593Regression, Logistic
Secondary
Percent Achievement of <110 mg/dL Fasting Plasma Glucose in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 110 mg/dL From Baseline to 4, 8, 12, and 16 Weeks
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 48.3 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 57.7 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 42.3 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 53.8 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 44.0 Percent of participants |
Comparison: Baseline to 4 Weeksp-value: 0.2079Cochran-Mantel-Haenszel
Comparison: Baseline to 8 Weeksp-value: 0.4053Cochran-Mantel-Haenszel
Comparison: Baseline to 12 Weeksp-value: 0.5752Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.799495% CI: [0.25, 2.29]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.99695% CI: [0.32, 3.03]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.7783Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.9774Regression, Logistic
Secondary
Percent Achievement of <140 mg/dL Plasma Glucose 2 Hours Post the Oral Glucose Tolerance Test in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was >or= to 140 mg/dL From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 37.3 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 37.7 Percent of participants |
Comparison: Baseline to 16 Weeksp-value: 0.588295% CI: [0.4, 1.83]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.709895% CI: [0.44, 1.96]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.6835Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.8461Regression, Logistic
Secondary
Percent Achievement of <140 mg/dL Plasma Glucose Post 2 Hour Glucose Tolerance Test and Fasting Plasma Glucose <110 mg/dL in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 32.0 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 30.6 Percent of participants |
Comparison: Baseline to 16 Weeksp-value: 0.479495% CI: [0.31, 1.4]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.666795% CI: [0.37, 1.55]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.2768Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.4395Regression, Logistic
Secondary
Percent Achievement of Hs-C-Reactive Protein <2.0 mg/L in Pre-Diabetic Subjects Whose Corresponding Baseline Value Was > or = to 2.0 mg/L From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 21.7 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 20.8 Percent of participants |
Comparison: Baseline to 16 Weeksp-value: 0.137595% CI: [0.89, 6.64]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.199695% CI: [0.85, 5.82]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.0829Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.1037Regression, Logistic
Secondary
Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 1.15 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 5.46 Percentage of change | Standard Error 1.232 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Apolipoprotein A-1 in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | 3.18 Percentage of change | Standard Error 1.19 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 5.67 Percentage of change | Standard Error 1.323 |
Comparison: Baseline to 8 Weeksp-value: 0.025795% CI: [0.43, 6.57]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.223895% CI: [-1.32, 5.58]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.276395% CI: [-1.44, 4.99]ANCOVA
Secondary
Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Apolipoprotein B in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | -8.62 Percentage of change | Standard Error 1.487 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -8.00 Percentage of change | Standard Error 1.807 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -7.52 Percentage of change | Standard Error 1.685 |
Comparison: Baseline to 8 Weeksp-value: <0.000195% CI: [-13.68, -5.98]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.000495% CI: [-13.4, -3.94]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.000495% CI: [-12.5, -3.68]ANCOVA
Secondary
Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 19.83 Percentage of change | Standard Error 4.611 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Apolipoprotein CIII in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | 17.71 Percentage of change | Standard Error 3.043 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 20.89 Percentage of change | Standard Error 5.231 |
Comparison: Baseline to 8 Weeksp-value: 0.000795% CI: [5.87, 21.74]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.090195% CI: [-1.83, 24.99]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.091895% CI: [-1.71, 22.62]ANCOVA
Secondary
Percent Change in Hemoglobin A1C (HbA1C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 4, 8, 12 and 16 Weeks.
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -1.17 Percentage of change in HbA1c | Standard Error 0.063 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.53 Percentage of change in HbA1c | Standard Error 0.044 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -1.05 Percentage of change in HbA1c | Standard Error 0.059 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.84 Percentage of change in HbA1c | Standard Error 0.055 |
Comparison: Baseline to 4 weeksp-value: 0.012395% CI: [-0.27, -0.03]ANCOVA
Comparison: Baseline to 8 Weeksp-value: 0.020195% CI: [-0.33, -0.03]ANCOVA
Comparison: Baseline to 12 weeksp-value: 0.023995% CI: [-0.36, -0.03]ANCOVA
Comparison: Baseline to 16 weeksp-value: 0.004695% CI: [-0.42, -0.08]ANCOVA
Secondary
Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 1.58 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 3.57 Percentage of change | Standard Error 1.601 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | 2.85 Percentage of change | Standard Error 1.433 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 3.56 Percentage of change | Standard Error 1.481 |
Comparison: Baseline to 8 Weeksp-value: 0.035795% CI: [0.27, 7.66]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.687895% CI: [-5.01, 3.31]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.797295% CI: [-4.37, 3.36]ANCOVA
Secondary
Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Hs-C-Reactive Protein in Pre-Diabetic Subjects From Baseline to 16 Weeks | Baseline to 16 Weeks | -13.43 Percentage of change |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -14.12 Percentage of change |
Comparison: Baseline to 16 Weeksp-value: 0.652395% CI: [-17.5, 10.32]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.393495% CI: [-17.51, 8.77]ANCOVA
Secondary
Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Low Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | -17.88 Percentage of change | Standard Error 1.921 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -15.08 Percentage of change | Standard Error 2.209 |
Comparison: Baseline to 8 Weeksp-value: <0.000195% CI: [-24.61, -14.63]ANCOVA
Comparison: Baseline to 16 Weeksp-value: <0.000195% CI: [-23.24, -11.69]ANCOVA
Secondary
Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 1.85 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Non-High Density Lipoprotein-Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | -10.98 Percentage of change | Standard Error 1.461 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -9.08 Percentage of change | Standard Error 1.867 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -8.37 Percentage of change | Standard Error 1.77 |
Comparison: Baseline to 8 Weeksp-value: <0.000195% CI: [-16.26, -8.69]ANCOVA
Comparison: Baseline to 16 Weeksp-value: <0.000195% CI: [-15.15, -5.41]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.000295% CI: [-13.69, -4.42]ANCOVA
Secondary
Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Total Cholesterol in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | -8.15 Percentage of change | Standard Error 1.206 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -6.59 Percentage of change | Standard Error 1.536 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -6.01 Percentage of change | Standard Error 1.452 |
Comparison: Baseline to 8 Weeksp-value: <0.000195% CI: [-12.02, -5.8]ANCOVA
Comparison: Baseline to 16 Weeksp-value: <0.000195% CI: [-12.25, -4.26]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.000295% CI: [-11.03, -3.44]ANCOVA
Secondary
Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | 0.00 Percentage of change |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change in Triglycerides in Pre-Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | 16.57 Percentage of change |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 5.91 Percentage of change |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 5.91 Percentage of change |
Comparison: Baseline to 8 Weeksp-value: 0.000595% CI: [6.27, 25.83]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.001195% CI: [6.33, 26.02]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.000995% CI: [5.11, 23.84]ANCOVA
Secondary
Percent Change of Apolipoprotein A-1 (Apo A-1) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 6.12 Percentage of change in Apo A-1 | Standard Error 1.027 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 8.51 Percentage of change in Apo A-1 | Standard Error 1.024 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 8.45 Percentage of change in Apo A-1 | Standard Error 0.953 |
Comparison: Baseline to 8 weeksp-value: 0.049695% CI: [0, 5.62]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.011795% CI: [0.82, 6.47]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.000995% CI: [1.83, 7.03]ANCOVA
Secondary
Percent Change of Apolipoprotein B (Apo B)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 1.34 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 16.15 Percentage of change in Apo B | Standard Error 1.158 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -13.42 Percentage of change in Apo B | Standard Error 1.307 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -12.17 Percentage of change in Apo B | Standard Error 1.239 |
Comparison: Baseline to 8 Weeksp-value: <0.000195% CI: [-14.74, -8.38]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.000195% CI: [-13.14, -5.92]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: <0.000195% CI: [-11.35, -4.59]ANCOVA
Secondary
Percent Change of Apolipoprotein C3 (Apo C3)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 17.89 Percentage of change in Apo C3 | Standard Error 2.62 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 12.58 Percentage of change in Apo C3 | Standard Error 2.495 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 18.58 Percentage of change in Apo C3 | Standard Error 2.871 |
Comparison: Baseline to 8 Weeksp-value: 0.000395% CI: [5.76, 19.38]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.000395% CI: [6.64, 22.4]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: <0.000195% CI: [7.95, 22.2]ANCOVA
Secondary
Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.512 Percentage of change | Standard Error 1.077 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change of Fasting Insulin in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4 Weeks | -0.348 Percentage of change | Standard Error 0.6769 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.513 Percentage of change | Standard Error 0.4377 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -2.066 Percentage of change | Standard Error 0.4463 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.497 Percentage of change | Standard Error 1.198 |
Comparison: Baseline to 4 Weeksp-value: 0.298295% CI: [-0.821, 2.663]ANCOVA
Comparison: Baseline to 8 Weeksp-value: 0.236195% CI: [-0.458, 1.848]ANCOVA
Comparison: Baseline to 12 Weeksp-value: 0.041395% CI: [-2.388, -0.049]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.785895% CI: [-3.583, 2.715]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.731495% CI: [-3.321, 2.335]ANCOVA
Secondary
Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -3.1 Percentage of change | Standard Error 1.67 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -3.1 Percentage of change | Standard Error 0.95 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -2.4 Percentage of change | Standard Error 1.13 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -2.8 Percentage of change | Standard Error 1.86 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change of Fasting Plasma Glucose in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4 weeks | -3.5 Percentage of change | Standard Error 0.97 |
Comparison: Baseline to 4 Weeksp-value: 0.000995% CI: [-6.8, -1.8]ANCOVA
Comparison: Baseline to 8 Weeksp-value: 0.118495% CI: [-4.5, 0.5]ANCOVA
Comparison: Baseline to 12 Weeksp-value: 0.061595% CI: [-5.8, 0.1]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.361795% CI: [-7.2, 2.6]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.237295% CI: [-7, 1.7]ANCOVA
Secondary
Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 0.03 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.12 Percentage of change | Standard Error 0.031 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.10 Percentage of change | Standard Error 0.026 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change of HbA1c in Pre-Diabetic Subjects From Baseline to 4, 8, 12, and 16 Weeks | Baseline to 4 weeks | -0.09 Percentage of change | Standard Error 0.028 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.11 Percentage of change | Standard Error 0.027 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -0.11 Percentage of change | Standard Error 0.034 |
Comparison: Baseline to 4 Weeksp-value: 0.297195% CI: [-0.11, 0.03]ANCOVA
Comparison: Baseline to 8 Weeksp-value: 0.256795% CI: [-0.11, 0.03]ANCOVA
Comparison: Baseline to 12 Weeksp-value: 0.108195% CI: [-0.13, 0.01]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.07995% CI: [-0.17, 0.01]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.020695% CI: [-0.18, -0.01]ANCOVA
Secondary
Percent Change of High Density Lipoprotein Cholesterol(HDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 1.16 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 8.78 Percentage of change | Standard Error 1.25 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 8.39 Percentage of change | Standard Error 1.165 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 5.61 Percentage of change | Standard Error 1.488 |
Comparison: Baseline to 8 Weeksp-value: 0.202695% CI: [-1.43, 6.7]ANCOVA
Comparison: Baseline to 16 Weeksp-value: 0.450695% CI: [-2.12, 4.75]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.260995% CI: [-1.35, 4.97]ANCOVA
Secondary
Percent Change of Non-High Density Lipoprotein (Non-HDL) Levels When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 1.46 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -18.19 percentage of change in non-HDL | Standard Error 1.316 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -14.36 percentage of change in non-HDL | Standard Error 1.436 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -13.70 percentage of change in non-HDL | Standard Error 1.346 |
Comparison: Baseline to 8 Weeksp-value: <0.000195% CI: [-15.99, -8.81]ANCOVA
Comparison: Baseline to 16 Weeksp-value: <0.000195% CI: [-13.23, -5.34]ANCOVA
Comparison: Baseline to 16 Week LOCFp-value: <0.000195% CI: [-11.98, -4.67]ANCOVA
Secondary
Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -9.31 Percentage of change of TC | Standard Error 1.121 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change of Total Cholesterol (TC) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | -13.26 Percentage of change of TC | Standard Error 1 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -9.79 Percentage of change of TC | Standard Error 1.197 |
Comparison: Baseline to 8 Weeksp-value: <0.000195% CI: [-11.53, -6.08]ANCOVA
Comparison: Baseline to 16 Weeksp-value: <0.000195% CI: [-10.23, -3.66]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: 0.000195% CI: [-9.14, -3.05]ANCOVA
Secondary
Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent Change of Triglycerides (TG)When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks | Baseline to 8 Weeks | 1.28 Percentage of change of TG |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 8.80 Percentage of change of TG |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 8.63 Percentage of change of TG |
Comparison: Baseline to 8 weeksp-value: 0.017195% CI: [-0.33, 13.99]ANCOVA
Comparison: Baseline to 16 Weeksp-value: <0.000195% CI: [9.66, 25.54]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: <0.000195% CI: [11.18, 25.74]ANCOVA
Secondary
Percent Change of Various Calculated Lipid Parameters When Given as Initial Therapy to Drug-naïve, Diabetic From Baseline to 16 Weeks Subjects
These calculated values are reported as part of an NMR analysis. The calculations are done by LipoScience, Inc., and are proprietary.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 30.28 Percentage of change |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 14.48 Percentage of change |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 17.86 Percentage of change |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 | 8.70 Percentage of change |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 | 0.99 Percentage of change |
| Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF) | 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 | 6.62 Percentage of change |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | 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 | 31.34 Percentage of change |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | 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 | 15.11 Percentage of change |
| Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF) | 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 | 17.39 Percentage of change |
Comparison: Calculated Triglyceridesp-value: 0.014495% CI: [2.57, 23.05]ANCOVA
Comparison: Calculated Triglyceridesp-value: 0.003795% CI: [4.63, 23.61]ANCOVA
Comparison: Calculated Very Low Density Lipoprotein Triglyceridesp-value: 0.00695% CI: [6.59, 39]ANCOVA
Comparison: Calculated Very Low Density Lipoprotein Triglyceridesp-value: 0.001395% CI: [9.71, 39.73]ANCOVA
Comparison: Calculated High Density Lipoprotein-Cholesterolp-value: 0.000595% CI: [3.71, 13]ANCOVA
Comparison: Calculated High Density Lipoprotein-Cholesterolp-value: 0.000195% CI: [4.27, 13.11]ANCOVA
Secondary
Percent of Subject Achieving HbA1c Goal of <6.5% at Weeks 4, 8, 12, and 16 When Given to Drug-naïve, Diabetic Subjects
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 52.2 Percent of particpants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 51.3 Percent of particpants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 24.8 Percent of particpants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 36.4 Percent of particpants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 55.9 Percent of particpants |
Comparison: Baseline to 4 Weeksp-value: 0.0008Cochran-Mantel-Haenszel
Comparison: Baseline to 8 Weeksp-value: 0.028Cochran-Mantel-Haenszel
Comparison: Baseline to 12 Weeksp-value: 0.0414Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.084Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.0589Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.009595% CI: [1.21, 3.96]Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.008895% CI: [1.2, 3.6]Regression, Logistic
Secondary
Percent of Subjects Achieving 2-Hr. Post Meal Glucose Goal of <180 mg/dL When Given to Drug-naïve, Diabetic Subjects From Baseline to Week 16
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 41.6 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 41.2 Percent of participants |
Comparison: Baseline to 16 Weeksp-value: 0.880495% CI: [0.63, 2.34]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.552595% CI: [0.73, 2.6]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.5648Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.317Regression, Logistic
Secondary
Percent of Subjects Achieving HbA1c Goal of <7.0% at Weeks 4, 8, 12, and 16 if Baseline HbA1c Was > or = to 7.0% When Given to Drug-naïve, Diabetics
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 66.7 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 25.8 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 48.4 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 64.0 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 72.4 Percent of participants |
Comparison: Baseline to 4 Weeksp-value: 0.5848Cochran-Mantel-Haenszel
Comparison: Baseline to 8 weeksp-value: 0.8147Cochran-Mantel-Haenszel
Comparison: Baseline to 12 Weeksp-value: 0.4957Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.0467Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.0589Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.004995% CI: [1.38, 6.1]Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.009295% CI: [1.25, 4.76]Regression, Logistic
Secondary
Percent of Subjects Achieving Hs-C-Reactive Protein Goal of <2.0 mg/L When Given to Drug-naïve, Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 22.0 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 20.0 Percent of participants |
Comparison: Baseline to 16 Weeksp-value: 0.900895% CI: [0.66, 4.06]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.903595% CI: [0.6, 3.37]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.2874Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.4344Regression, Logistic
Secondary
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol Goal of <70 mg/dL at Weeks 8, 16 When Given as to Drug-naïve, Diabetics
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 13.7 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 12.9 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 12.5 Percent of participants |
Comparison: Baseline to 8 Weeksp-value: 0.0004Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.0326Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.0157Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.08795% CI: [0.88, 7.07]Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.0043995% CI: [1.03, 7.94]Regression, Logistic
Secondary
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects | Baseline to 8 Weeks | 29.2 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 29.1 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 28.7 Percent of participants |
Comparison: Baseline to 8 Weeksp-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.001895% CI: [2.06, 13.58]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.001995% CI: [1.89, 10.54]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.0005Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.0007Regression, Logistic
Secondary
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <100 mg/dL at Weeks 8, 16 When Given to Drug-naïve, Diabetic Subjects
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 54.8 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 50.0 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 48.0 Percent of participants |
Comparison: Baseline to 8 Weeksp-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: <0.000195% CI: [2.78, 11.23]Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: <0.000195% CI: [2.53, 9.1]Regression, Logistic
Secondary
Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | Percent of Subjects Achieving Low Density Lipoprotein-Cholesterol of <70 mg/dL at Weeks 8, 16 in Pre-Diabetic Subjects | Baseline to 8 Weeks | 11.2 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 7.4 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 6.8 Percent of participants |
Comparison: Baseline to 8 Weeksp-value: 0.0104Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.222495% CI: [0.53, 9.39]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeks LOCFp-value: 0.19995% CI: [0.53, 9.33]Cochran-Mantel-Haenszel
Comparison: Baseline to 16 Weeksp-value: 0.2778Regression, Logistic
Comparison: Baseline to 16 Weeks LOCFp-value: 0.2785Regression, Logistic
Secondary
Percent of Subjects Meeting Type 2 Diabetes Criteria (Fasting Plasma Glucose >or= to 126 mg/dL or Plasma Glucose >or= to 200 mg/dL Post 2 Hr Glucose Tolerance Test in Pre-Diabetic Subjects From Baseline to 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 11.1 Percent of participants |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | 10.7 Percent of participants |
Secondary
The Percent Change of Low Density Lipoprotein Cholesterol (LDL-C) When Given to Drug-naïve, Diabetic Subjects From Baseline to 8, and 16 Weeks
Time frame: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Placebo+Metformin | 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 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -24.01 percentage of change in LDL-C | Standard Error 1.614 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -22.02 percentage of change in LDL-C | Standard Error 1.813 |
| Type 2 Diabetes Group:Colesevelam+Metformin | 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 | -21.44 percentage of change in LDL-C | Standard Error 1.7 |
Comparison: Baseline to 8 Weeksp-value: <0.000195% CI: [-22.61, -13.76]ANCOVA
Comparison: Baseline to 16 Weeksp-value: <0.000195% CI: [-22.09, -12.08]ANCOVA
Comparison: Baseline to 16 Weeks LOCFp-value: <0.000195% CI: [-20.96, -11.69]ANCOVA