Trial Outcomes & Findings for Colesevelam for Children With Type 2 Diabetes (NCT NCT01258075)
NCT ID: NCT01258075
Last Updated: 2021-05-13
Results Overview
The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
236 participants
Primary outcome timeframe
Baseline to Month 6 post-dose
Results posted on
2021-05-13
Participant Flow
A total of 236 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized to either Welchol 3.75 g (high-dose) or Welchol 0.625 g (low-dose).
Participants may have either been receiving metformin monotherapy or untreated with antidiabetic agents. All participants entered a 2-week, single-blind lead in/stabilization period after eligibility was confirmed. Metformin dose remained the same during the stabilization period.
Participant milestones
| Measure |
Welchol 3.75 g (High-dose)
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
95
|
|
Overall Study
COMPLETED
|
99
|
72
|
|
Overall Study
NOT COMPLETED
|
42
|
23
|
Reasons for withdrawal
| Measure |
Welchol 3.75 g (High-dose)
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
3
|
|
Overall Study
Lost to Follow-up
|
11
|
6
|
|
Overall Study
Withdrawal by Subject
|
10
|
7
|
|
Overall Study
Hyperglycemia meeting protocol-specified discontinuation criteria
|
1
|
2
|
|
Overall Study
Other
|
12
|
5
|
Baseline Characteristics
Colesevelam for Children With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Welchol 3.75 g (High-dose)
n=141 Participants
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=95 Participants
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 2.09 • n=99 Participants
|
14.2 years
STANDARD_DEVIATION 2.02 • n=107 Participants
|
14.2 years
STANDARD_DEVIATION 2.06 • n=206 Participants
|
|
Age, Customized
10-13 years
|
51 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Age, Customized
14-17 years
|
90 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
152 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
181 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
141 participants
n=99 Participants
|
95 participants
n=107 Participants
|
236 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 6 post-dosePopulation: Change in HbA1c levels were assessed in the Intent-to-Treat population.
The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Outcome measures
| Measure |
Welchol 3.75 g (High-dose)
n=132 Participants
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=88 Participants
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
|
0.09 percent change
Interval -0.18 to 0.36
|
0.21 percent change
Interval -0.11 to 0.54
|
SECONDARY outcome
Timeframe: Baseline to Month 12 post-dosePopulation: Change in HbA1c levels were assessed in the Intent-to-Treat population. Only those participants with data available at the specified time points were analyzed.
The percent change in HbA1c from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Outcome measures
| Measure |
Welchol 3.75 g (High-dose)
n=122 Participants
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=83 Participants
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Month 3
|
-0.27 percent change
Interval -0.49 to -0.06
|
-0.05 percent change
Interval -0.31 to 0.22
|
|
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Month 9
|
-0.06 percent change
Interval -0.42 to 0.3
|
-0.16 percent change
Interval -0.61 to 0.3
|
|
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Month 6
|
-0.12 percent change
Interval -0.38 to 0.14
|
-0.06 percent change
Interval -0.37 to 0.26
|
|
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Month 12
|
-0.31 percent change
Interval -0.61 to -0.01
|
-0.38 percent change
Interval -0.76 to 0.01
|
|
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Month 12/Early termination
|
-0.19 percent change
Interval -0.54 to 0.15
|
-0.10 percent change
Interval -0.55 to 0.35
|
SECONDARY outcome
Timeframe: Baseline to Month 12 post-dosePopulation: FPG values were assessed in the Intent-to-Treat population. Only those participants with data available at the specified time points were analyzed.
Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.
Outcome measures
| Measure |
Welchol 3.75 g (High-dose)
n=90 Participants
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=61 Participants
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Month 6
|
11.6 mg/dL
Interval 1.8 to 21.4
|
16.7 mg/dL
Interval 4.7 to 28.7
|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Month 12
|
15.5 mg/dL
Interval 2.9 to 28.1
|
10.6 mg/dL
Interval -5.8 to 27.0
|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Month 12/Early termination
|
14.6 mg/dL
Interval 2.9 to 26.4
|
11.6 mg/dL
Interval -4.5 to 27.7
|
SECONDARY outcome
Timeframe: Baseline to Month 12 post-dosePopulation: Response to therapy was assessed in the Intent-to-Treat population.
Participants achieving a response to therapy, ie, glycemic control, were assessed with the last observation after 1 month before any rescue therapy carried forward at Month 6 and Month 12. Response to therapy was defined as HbA1c \<7.0% or \<6.5%, reduction in HbA1c ≥0.7% or ≥0.5% from baseline, and/or reduction in FPG ≥30 mg/dL from baseline.
Outcome measures
| Measure |
Welchol 3.75 g (High-dose)
n=132 Participants
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=88 Participants
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 6 (LOCF): Achieving HBA1C <6.5%
|
26 Participants
|
11 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 6 (LOCF): Achieving a reduction in HBA1C of ≥0.5%
|
44 Participants
|
32 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 6 (LOCF): Achieving a reduction in FPG ≥30 mg/dL
|
17 Participants
|
10 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Reduction in HBA1C of ≥0.7% and/or in FPG of ≥30 mg/dL from baseline to Month 6 with & without LOCF
|
37 Participants
|
25 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Reduction in HBA1C of ≥0.5% and/or in FPG of ≥30 mg/dL from baseline to Month 6 with & without LOCF
|
49 Participants
|
36 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12: Achieving HBA1C <7%
|
26 Participants
|
18 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12: Achieving HBA1C <6.5%
|
19 Participants
|
8 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12: Achieving a reduction in HBA1C of ≥0.7%
|
15 Participants
|
11 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12: Achieving a reduction in HBA1C of ≥0.5%
|
19 Participants
|
16 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12/Early termination: Achieving a reduction in HBA1C of ≥0.7%
|
20 Participants
|
13 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 6 (LOCF): Achieving HBA1C <7%
|
39 Participants
|
26 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 6 (LOCF): Achieving a reduction in HBA1C of ≥0.7%
|
32 Participants
|
20 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12: Achieving a reduction in FPG ≥30 mg/dL
|
4 Participants
|
0 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Reduction in HBA1C of ≥0.7% and/or in FPG of ≥30 mg/dL from baseline to Month 12
|
15 Participants
|
11 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Reduction in HBA1C of ≥0.5% and/or in FPG of ≥30 mg/dL from baseline to Month 12
|
19 Participants
|
16 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12/Early termination: Achieving HBA1C <7%
|
33 Participants
|
19 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12/Early termination: Achieving HBA1C <6.5%
|
21 Participants
|
8 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12/Early termination: Achieving a reduction in HBA1C of ≥0.5%
|
27 Participants
|
18 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Month 12/Early termination: Achieving a reduction in FPG ≥30 mg/dL
|
5 Participants
|
0 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Reduction in HBA1C of ≥0.7% and/or in FPG of ≥30 mg/dL from baseline to Month 12/Early termination
|
21 Participants
|
13 Participants
|
|
Number of Participants Achieving a Response to Therapy to Month 12
Reduction in HBA1C of ≥0.5% and/or in FPG of ≥30 mg/dL from baseline to Month 12/Early termination
|
28 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 6 post-dosePopulation: Change in lipid values were assessed in the Intent-to-Treat population. Only those participants with data available at the specified time points were analyzed.
The percent change in plasma lipids from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Outcome measures
| Measure |
Welchol 3.75 g (High-dose)
n=117 Participants
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=77 Participants
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Plasma Lipids
Total cholesterol
|
1.0 percent change
Interval -1.3 to 3.4
|
3.2 percent change
Interval 0.3 to 6.1
|
|
Percent Change From Baseline to Month 6 in Plasma Lipids
Low-density lipoprotein cholesterol
|
-1.1 percent change
Interval -4.7 to 2.4
|
4.4 percent change
Interval 0.0 to 8.8
|
|
Percent Change From Baseline to Month 6 in Plasma Lipids
High-density lipoprotein cholesterol
|
1.9 percent change
Interval -0.8 to 4.7
|
2.3 percent change
Interval -1.1 to 5.7
|
|
Percent Change From Baseline to Month 6 in Plasma Lipids
Non-High-density lipoprotein cholesterol
|
1.2 percent change
Interval -1.9 to 4.2
|
4.1 percent change
Interval 0.4 to 7.8
|
|
Percent Change From Baseline to Month 6 in Plasma Lipids
Apolipoprotein A-1
|
2.3 percent change
Interval 0.2 to 4.5
|
3.1 percent change
Interval 0.4 to 5.7
|
|
Percent Change From Baseline to Month 6 in Plasma Lipids
Apolipoprotein B
|
0.8 percent change
Interval -2.0 to 3.5
|
2.7 percent change
Interval -0.7 to 6.2
|
SECONDARY outcome
Timeframe: Baseline to Month 6 post-dosePopulation: Triglyceride values were assessed in the Intent-to-Treat population. Only those participants with data available at the specified time points were analyzed.
The percent change in triglycerides from baseline to Month 6 was assessed with the last observation after 1 month before any rescue therapy carried forward.
Outcome measures
| Measure |
Welchol 3.75 g (High-dose)
n=117 Participants
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=77 Participants
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Percent Change From Baseline to Month 6 in Triglycerides
|
10.0 mg/dL
Interval 2.8 to 17.8
|
6.4 mg/dL
Interval -3.8 to 15.8
|
SECONDARY outcome
Timeframe: Baseline to Month 12 post-dosePopulation: Participants meeting rescue criteria were assessed in the Intent-to-Treat population.
Rescue criteria was defined as HbA1c levels ≥8.5% after 3 months or ≥7.5% after 6 months (≥173 days) (confirmed persistent hyperglycemia) of study medication treatment, as measured by the central laboratory.
Outcome measures
| Measure |
Welchol 3.75 g (High-dose)
n=132 Participants
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=88 Participants
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Initially met rescue criteria at >Month 12
|
9 Participants
|
4 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Met rescue criteria 1 time
|
16 Participants
|
8 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Took rescue medication after meeting criteria 1 time
|
4 Participants
|
0 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Did not take rescue medication after meeting criteria 1 time
|
12 Participants
|
8 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Met rescue criteria 2 times
|
18 Participants
|
5 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Took rescue medication after meeting criteria 2 times
|
12 Participants
|
3 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Did not take rescue medication after meeting criteria 2 times
|
6 Participants
|
2 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Met rescue criteria >2 times
|
50 Participants
|
45 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Took rescue medication after meeting criteria >2 times
|
43 Participants
|
42 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Did not take rescue medication after meeting criteria >2 times
|
7 Participants
|
3 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Initially met rescue criteria at Month 3 to <Month 6
|
25 Participants
|
19 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Initially met rescue criteria at Month 6 to <Month 9
|
41 Participants
|
29 Participants
|
|
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Initially met rescue criteria at Month 9 to <Month 12
|
9 Participants
|
6 Participants
|
Adverse Events
Welchol 3.75 g (High-dose)
Serious events: 10 serious events
Other events: 85 other events
Deaths: 0 deaths
Welchol 0.625 g (Low-dose)
Serious events: 9 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Welchol 3.75 g (High-dose)
n=141 participants at risk
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=95 participants at risk
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labor
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Psychiatric disorders
Abnormal behavior
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Infections and infestations
Appendicitis
|
1.4%
2/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
2/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Psychiatric disorders
Depression
|
1.4%
2/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Nervous system disorders
Headache
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Eye disorders
Vision blurred
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Psychiatric disorders
Drug abuse
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Psychiatric disorders
Suicide attempt
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Psychiatric disorders
Aggression
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.71%
1/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
0.00%
0/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
Other adverse events
| Measure |
Welchol 3.75 g (High-dose)
n=141 participants at risk
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
|
Welchol 0.625 g (Low-dose)
n=95 participants at risk
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
8/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
4.2%
4/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
12/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
9.5%
9/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
10/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
1.1%
1/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
9.2%
13/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
10.5%
10/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Gastrointestinal disorders
Nausea
|
5.7%
8/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
7.4%
7/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
14.2%
20/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
11.6%
11/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
General disorders
Pyrexia
|
5.0%
7/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
5.3%
5/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.0%
24/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
9.5%
9/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
7/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
6.3%
6/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.1%
3/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
6.3%
6/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
10/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
8.4%
8/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.8%
18/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
14.7%
14/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Nervous system disorders
Headache
|
12.1%
17/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
8.4%
8/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
10/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
6.3%
6/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
10/141 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
10.5%
10/95 • Adverse event data were assessed from the date the participant signs the informed consent form up to the end of the study assessment and follow-up period, up to approximately 58 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place