Trial Outcomes & Findings for Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin (NCT NCT00484419)
NCT ID: NCT00484419
Last Updated: 2016-10-04
Results Overview
Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.
COMPLETED
PHASE3
169 participants
16 weeks change = week 16 - week 0.
2016-10-04
Participant Flow
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.
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
Participant milestones
| Measure |
Colesevelam
colesevelam tablets 625 mg
|
Rosiglitazone
rosiglitazone maleate 4mg
|
Sitagliptin
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
57
|
56
|
56
|
|
Overall Study
COMPLETED
|
45
|
51
|
45
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
11
|
Reasons for withdrawal
| Measure |
Colesevelam
colesevelam tablets 625 mg
|
Rosiglitazone
rosiglitazone maleate 4mg
|
Sitagliptin
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
|
Overall Study
subject met discontinuation criteria
|
2
|
2
|
4
|
|
Overall Study
required restricted medication
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
|
Overall Study
subject unable to receive medication
|
1
|
0
|
0
|
|
Overall Study
subject relocated
|
0
|
1
|
0
|
|
Overall Study
sponsor decision, randomized in error
|
0
|
0
|
2
|
Baseline Characteristics
Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin
Baseline characteristics by cohort
| Measure |
Colesevelam
n=57 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=56 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=56 Participants
sitagliptin phosphate tablets 100mg
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 9.19 • n=5 Participants
|
54.7 years
STANDARD_DEVIATION 10.92 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 9.96 • n=4 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
21 participants
n=5 Participants
|
12 participants
n=7 Participants
|
19 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=5 Participants
|
19 participants
n=7 Participants
|
12 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
74 participants
n=4 Participants
|
|
Fasting Insulin
|
9.406 uIU/mL
n=5 Participants
|
9.945 uIU/mL
n=7 Participants
|
8.886 uIU/mL
n=5 Participants
|
9.396 uIU/mL
n=4 Participants
|
|
Fasting Plasma Glucose
|
174.5 mg/dL
n=5 Participants
|
177.7 mg/dL
n=7 Participants
|
180.6 mg/dL
n=5 Participants
|
177.6 mg/dL
n=4 Participants
|
|
HbA1c
|
8.10 percent
n=5 Participants
|
8.06 percent
n=7 Participants
|
8.17 percent
n=5 Participants
|
8.11 percent
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=46 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=51 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=43 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
|
-0.31 % change HbA1c
Standard Deviation 0.898
|
-0.65 % change HbA1c
Standard Deviation 0.836
|
-0.56 % change HbA1c
Standard Deviation 1.044
|
SECONDARY outcome
Timeframe: 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.
Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=56 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=54 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=55 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean
|
-0.27 % change in HbA1c
Interval -0.52 to -0.02
|
-0.58 % change in HbA1c
Interval -0.83 to -0.32
|
-0.38 % change in HbA1c
Interval -0.64 to -0.13
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Colesevelam
n=51 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=53 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=48 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8
|
-0.31 % change in HbA1c
Standard Deviation 0.772
|
-0.19 % change in HbA1c
Standard Deviation 0.842
|
-0.48 % change in HbA1c
Standard Deviation 0.751
|
SECONDARY outcome
Timeframe: 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.
change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
Outcome measures
| Measure |
Colesevelam
n=51 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=53 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=48 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean
|
-15.6 mg/dL
Interval -25.8 to -5.3
|
-28.9 mg/dL
Interval -38.9 to -18.8
|
-17.4 mg/dL
Interval -28.0 to -6.9
|
SECONDARY outcome
Timeframe: 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.
change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=46 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=51 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=45 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
|
-17.3 mg/dL
Interval -28.9 to -5.7
|
-31.4 mg/dL
Interval -42.5 to -20.4
|
-24.4 mg/dL
Interval -36.1 to -12.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Colesevelam
n=51 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=53 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=48 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Change in FPG From Week 0(Baseline) to Week 8
|
-12.5 mg/dL
Standard Deviation 32.22
|
-30.8 mg/dL
Standard Deviation 59.67
|
-18.6 mg/dL
Standard Deviation 63.56
|
SECONDARY outcome
Timeframe: 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.
change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=46 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=51 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=45 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Change in FPG From Week 0(Baseline) to Week 16
|
-15.8 mg/dL
Standard Deviation 41.53
|
-34.0 mg/dL
Standard Deviation 63.55
|
-23.1 mg/dL
Standard Deviation 59.49
|
SECONDARY outcome
Timeframe: 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.
change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
Outcome measures
| Measure |
Colesevelam
n=48 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=47 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=45 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean
|
0.075 uIU/mL
Interval -3.442 to 3.592
|
-2.156 uIU/mL
Interval -5.72 to 1.408
|
4.002 uIU/mL
Interval 0.371 to 7.633
|
SECONDARY outcome
Timeframe: 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.
change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=45 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=45 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=44 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean
|
-0.320 uIU/mL
Interval -1.757 to 1.116
|
-1.482 uIU/mL
Interval -2.922 to -0.041
|
0.092 uIU/mL
Interval -1.363 to 1.547
|
SECONDARY outcome
Timeframe: 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.
mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.
Outcome measures
| Measure |
Colesevelam
n=48 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=47 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=45 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8
|
0.107 uIU/mL
Standard Deviation 4.1543
|
-2.213 uIU/mL
Standard Deviation 6.5833
|
4.028 uIU/mL
Standard Deviation 20.1202
|
SECONDARY outcome
Timeframe: 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.
mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=45 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=45 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=44 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16
|
-0.212 uIU/mL
Standard Deviation 3.7914
|
-1.910 uIU/mL
Standard Deviation 8.5117
|
-0.419 uIU/mL
Standard Deviation 3.6669
|
SECONDARY outcome
Timeframe: 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.
change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=45 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=48 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=45 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean
|
-17.7 mg/dL
Interval -34.8 to -0.7
|
-53.6 mg/dL
Interval -70.1 to -37.1
|
-43.6 mg/dL
Interval -60.7 to -26.6
|
SECONDARY outcome
Timeframe: 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.
mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=45 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=48 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=45 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16
|
-20.1 mg/dL
Standard Deviation 62.73
|
-54.0 mg/dL
Standard Deviation 67.51
|
-40.9 mg/dL
Standard Deviation 65.72
|
SECONDARY outcome
Timeframe: 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.
mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=43 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=46 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=44 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16
|
3.898 mg/dL
Standard Deviation 22.8717
|
1.962 mg/dL
Standard Deviation 26.0326
|
4.832 mg/dL
Standard Deviation 24.6608
|
SECONDARY outcome
Timeframe: 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.
change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=43 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=47 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=44 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean
|
-19.5 mg/dL
Interval -26.5 to -12.6
|
4.9 mg/dL
Interval -1.8 to 11.5
|
6.2 mg/dL
Interval -0.7 to 13.0
|
SECONDARY outcome
Timeframe: 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.
mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=43 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=47 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=44 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Change in LDL-C From Week 0(Baseline) to Week 16
|
-19.7 mg/dL
Standard Deviation 23.85
|
5.5 mg/dL
Standard Deviation 28.27
|
5.7 mg/dL
Standard Deviation 22.33
|
SECONDARY outcome
Timeframe: 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.
mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.
Outcome measures
| Measure |
Colesevelam
n=43 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=47 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=44 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
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
|
7.41 % change in LDL-C
Standard Deviation 25.989
|
7.61 % change in LDL-C
Standard Deviation 21.180
|
SECONDARY outcome
Timeframe: 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.
percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)
Outcome measures
| Measure |
Colesevelam
n=43 Participants
colesevelam tablets 625 mg
|
Rosiglitazone
n=47 Participants
rosiglitazone maleate 4mg
|
Sitagliptin
n=44 Participants
sitagliptin phosphate tablets 100mg
|
|---|---|---|---|
|
Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)
|
-16.24 % change in LDL-C
Interval -22.68 to -9.81
|
6.92 % change in LDL-C
Interval 0.76 to 13.08
|
7.98 % change in LDL-C
Interval 1.62 to 14.34
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Raia, Director, Professional Affairs
Daiichi Sankyo Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reflects the following restrictive language in the Clinical Study Agreements: "If identified by DSI, any of DSI's confidential information as defined herein shall be deleted…Nothing in this publication section shall be taken as giving DSI any right of editorial control over any publication prepared by the Study Site."
- Publication restrictions are in place
Restriction type: OTHER