Type 2 Diabetes, Hyperlipidemia
Conditions
Keywords
Colesevelam HCl,, rosiglitazone, sitagliptin, Type 2 diabetes, metformin
Brief summary
A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.
Interventions
DRUGColesevelam HCl
coleveselam tablets 625 mg; 6 tablets/day
rosiglitazone tablets 4mg
DRUGsitagliptin phosphate
sitagliptin phosphate tablets 100mg/day
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.
Exclusion criteria
* Subjects currently treated with a thiazolidinedione are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint | 16 weeks change = week 16 - week 0. | Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 | 8 weeks change = week 8- week 0. | change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0. |
| Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean | 8 weeks change = week 8- week 0. | change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0. |
| Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean | 16 weeks change = week 16 - week 0. | change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0. |
| Mean Change in FPG From Week 0(Baseline) to Week 8 | 8 weeks change = week 8- week 0. | mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0. |
| Mean Change in FPG From Week 0(Baseline) to Week 16 | 16 weeks change = week 16 - week 0. | change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0. |
| Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean | 8 weeks change = week 8- week 0. | change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0. |
| Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean | 16 weeks change = week 16 - week 0. | change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0. |
| Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 | 8 weeks change = week 8- week 0. | mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0. |
| Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean | 16 weeks change = week 16 - week 0. | Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0. |
| Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean | 16 weeks change = week 16 - week 0. | change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0. |
| Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 | 16 weeks change = week 16 - week 0. | mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0. |
| Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16 | 16 weeks change = week 16 - week 0. | mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0. |
| Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean | 16 weeks change = week 16 - week 0. | change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0. |
| Mean Change in LDL-C From Week 0(Baseline) to Week 16 | 16 weeks change = week 16 - week 0. | mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0. |
| Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 | 16 weeks change = week 16 - week 0. | mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0. |
| Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean) | 16 weeks change = week 16 - week 0. | percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval) |
| Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 | 16 weeks change = week 16 - week 0. | mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 18 May 2007 to 14 December 2007 at 6 sites in Colombia, 7 sites in Mexico, and 20 sites in the United States of America.
Pre-assignment details
Subjects on metformin-combination therapy entered a 4-week washout period from non-metformin antidiabetic drug. Population is type 2 diabetes mellitus subjects on stable metformin regimen, who discontinued other antidiabetic drugs, glycemia not controlled, and low-density lipoprotein-C (LDL-C) \>=60 mg/dL and triglycerides \<500 mg/dL
Participants by arm
| Arm | Count |
|---|---|
| Colesevelam colesevelam tablets 625 mg | 57 |
| Rosiglitazone rosiglitazone maleate 4mg | 56 |
| Sitagliptin sitagliptin phosphate tablets 100mg | 56 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 |
| Overall Study | Physician Decision | 1 | 1 | 1 |
| Overall Study | required restricted medication | 1 | 0 | 1 |
| Overall Study | sponsor decision, randomized in error | 0 | 0 | 2 |
| Overall Study | subject met discontinuation criteria | 2 | 2 | 4 |
| Overall Study | subject relocated | 0 | 1 | 0 |
| Overall Study | subject unable to receive medication | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | Colesevelam | Rosiglitazone | Sitagliptin | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants | 10 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 44 Participants | 46 Participants | 135 Participants |
| Age, Continuous | 56.6 years STANDARD_DEVIATION 9.19 | 54.7 years STANDARD_DEVIATION 10.92 | 54.8 years STANDARD_DEVIATION 9.76 | 55.4 years STANDARD_DEVIATION 9.96 |
| Fasting Insulin | 9.406 uIU/mL | 9.945 uIU/mL | 8.886 uIU/mL | 9.396 uIU/mL |
| Fasting Plasma Glucose | 174.5 mg/dL | 177.7 mg/dL | 180.6 mg/dL | 177.6 mg/dL |
| HbA1c | 8.10 percent | 8.06 percent | 8.17 percent | 8.11 percent |
| Region of Enrollment Colombia | 21 participants | 12 participants | 19 participants | 52 participants |
| Region of Enrollment Mexico | 12 participants | 19 participants | 12 participants | 43 participants |
| Region of Enrollment United States | 24 participants | 25 participants | 25 participants | 74 participants |
| Sex: Female, Male Female | 29 Participants | 33 Participants | 36 Participants | 98 Participants |
| Sex: Female, Male Male | 28 Participants | 23 Participants | 20 Participants | 71 Participants |
Outcome results
Primary
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint | -0.31 % change HbA1c | Standard Deviation 0.898 |
| Rosiglitazone | Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint | -0.65 % change HbA1c | Standard Deviation 0.836 |
| Sitagliptin | Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint | -0.56 % change HbA1c | Standard Deviation 1.044 |
Comparison: For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.p-value: 0.0234t-test, 2 sided
Comparison: For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.p-value: <0.0001t-test, 2 sided
Comparison: For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.p-value: 0.0011t-test, 2 sided
Secondary
Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean
change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Colesevelam | Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean | -0.320 uIU/mL |
| Rosiglitazone | Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean | -1.482 uIU/mL |
| Sitagliptin | Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean | 0.092 uIU/mL |
Secondary
Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean
change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
Time frame: 8 weeks change = week 8- week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Colesevelam | Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean | 0.075 uIU/mL |
| Rosiglitazone | Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean | -2.156 uIU/mL |
| Sitagliptin | Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean | 4.002 uIU/mL |
Secondary
Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean
change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
Time frame: 8 weeks change = week 8- week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Colesevelam | Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean | -15.6 mg/dL |
| Rosiglitazone | Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean | -28.9 mg/dL |
| Sitagliptin | Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean | -17.4 mg/dL |
Secondary
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Colesevelam | Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean | -17.3 mg/dL |
| Rosiglitazone | Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean | -31.4 mg/dL |
| Sitagliptin | Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean | -24.4 mg/dL |
Secondary
Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean
change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Colesevelam | Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean | -19.5 mg/dL |
| Rosiglitazone | Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean | 4.9 mg/dL |
| Sitagliptin | Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean | 6.2 mg/dL |
Secondary
Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean
change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Colesevelam | Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean | -17.7 mg/dL |
| Rosiglitazone | Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean | -53.6 mg/dL |
| Sitagliptin | Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean | -43.6 mg/dL |
Secondary
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16
mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 | -0.212 uIU/mL | Standard Deviation 3.7914 |
| Rosiglitazone | Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 | -1.910 uIU/mL | Standard Deviation 8.5117 |
| Sitagliptin | Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 | -0.419 uIU/mL | Standard Deviation 3.6669 |
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.7094t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.1394t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.4528t-test, 2 sided
Secondary
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8
mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.
Time frame: 8 weeks change = week 8- week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 | 0.107 uIU/mL | Standard Deviation 4.1543 |
| Rosiglitazone | Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 | -2.213 uIU/mL | Standard Deviation 6.5833 |
| Sitagliptin | Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 | 4.028 uIU/mL | Standard Deviation 20.1202 |
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.8596t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0257t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.1862t-test, 2 sided
Secondary
Mean Change in FPG From Week 0(Baseline) to Week 16
change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Change in FPG From Week 0(Baseline) to Week 16 | -15.8 mg/dL | Standard Deviation 41.53 |
| Rosiglitazone | Mean Change in FPG From Week 0(Baseline) to Week 16 | -34.0 mg/dL | Standard Deviation 63.55 |
| Sitagliptin | Mean Change in FPG From Week 0(Baseline) to Week 16 | -23.1 mg/dL | Standard Deviation 59.49 |
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0133t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0004t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0125t-test, 2 sided
Secondary
Mean Change in FPG From Week 0(Baseline) to Week 8
mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.
Time frame: 8 weeks change = week 8- week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Change in FPG From Week 0(Baseline) to Week 8 | -12.5 mg/dL | Standard Deviation 32.22 |
| Rosiglitazone | Mean Change in FPG From Week 0(Baseline) to Week 8 | -30.8 mg/dL | Standard Deviation 59.67 |
| Sitagliptin | Mean Change in FPG From Week 0(Baseline) to Week 8 | -18.6 mg/dL | Standard Deviation 63.56 |
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0077t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0004t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0483t-test, 2 sided
Secondary
Mean Change in LDL-C From Week 0(Baseline) to Week 16
mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Change in LDL-C From Week 0(Baseline) to Week 16 | -19.7 mg/dL | Standard Deviation 23.85 |
| Rosiglitazone | Mean Change in LDL-C From Week 0(Baseline) to Week 16 | 5.5 mg/dL | Standard Deviation 28.27 |
| Sitagliptin | Mean Change in LDL-C From Week 0(Baseline) to Week 16 | 5.7 mg/dL | Standard Deviation 22.33 |
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: <0.0001t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.1864t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0999t-test, 2 sided
Secondary
Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16
mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 | -20.1 mg/dL | Standard Deviation 62.73 |
| Rosiglitazone | Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 | -54.0 mg/dL | Standard Deviation 67.51 |
| Sitagliptin | Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 | -40.9 mg/dL | Standard Deviation 65.72 |
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0374t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: <0.0001t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0001t-test, 2 sided
Secondary
Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16
mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16 | 3.898 mg/dL | Standard Deviation 22.8717 |
| Rosiglitazone | Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16 | 1.962 mg/dL | Standard Deviation 26.0326 |
| Sitagliptin | Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16 | 4.832 mg/dL | Standard Deviation 24.6608 |
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.2701t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.6117t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.2007t-test, 2 sided
Secondary
Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean
Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Colesevelam | Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean | -0.27 % change in HbA1c |
| Rosiglitazone | Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean | -0.58 % change in HbA1c |
| Sitagliptin | Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean | -0.38 % change in HbA1c |
Secondary
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8
change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.
Time frame: 8 weeks change = week 8- week 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 | -0.31 % change in HbA1c | Standard Deviation 0.772 |
| Rosiglitazone | Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 | -0.19 % change in HbA1c | Standard Deviation 0.842 |
| Sitagliptin | Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 | -0.48 % change in HbA1c | Standard Deviation 0.751 |
Comparison: For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.p-value: 0.0061t-test, 2 sided
Comparison: For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.p-value: 0.109t-test, 2 sided
Comparison: For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.p-value: <0.0001t-test, 2 sided
Secondary
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16
mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Colesevelam | Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 | -16.40 % change in LDL-C | Standard Deviation 19.443 |
| Rosiglitazone | Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 | 7.41 % change in LDL-C | Standard Deviation 25.989 |
| Sitagliptin | Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 | 7.61 % change in LDL-C | Standard Deviation 21.18 |
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: <0.0001t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0566t-test, 2 sided
Comparison: P-value presents results from 1-sample t-test for within-treatment difference from baseline.p-value: 0.0217t-test, 2 sided
Secondary
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)
percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)
Time frame: 16 weeks change = week 16 - week 0.
Population: The Full Analysis Set population included all randomized subjects who had taken at least 1 dose of study medication, and had a baseline and at least 1 post baseline HbA1c measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Colesevelam | Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean) | -16.24 % change in LDL-C |
| Rosiglitazone | Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean) | 6.92 % change in LDL-C |
| Sitagliptin | Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean) | 7.98 % change in LDL-C |