Trial Outcomes & Findings for Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes (NCT NCT00993824)
NCT ID: NCT00993824
Last Updated: 2015-11-30
Results Overview
Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
21 participants
Primary outcome timeframe
2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Results posted on
2015-11-30
Participant Flow
Recruitment Jan 2010 to Mar 2011. Medical Clinic Setting.
Participant milestones
| Measure |
Welchol Then Placebo
3.75 grams of colesevelam HCl (Welchol) taken for 12 weeks at evening meal, and then crossover to placebo taken at evening meal fro 12 weeks.
|
Placebo Then Welchol
Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glycemic Effect of Colesevelam HCl (Welchol) in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Welchol Then Placebo
n=11 Participants
3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
|
Placebo Then Welchol
n=10 Participants
Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
|
Total
n=21 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
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
59.5 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Total norm AUC average
|
162.2 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 16.0 • n=5 Participants
|
167.7 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 25.9 • n=7 Participants
|
164.8 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 20.9 • n=5 Participants
|
|
Sleep norm Area under the curve average by group
|
157.1 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 14.3 • n=5 Participants
|
161.2 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 23.4 • n=7 Participants
|
159.1 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 18.8 • n=5 Participants
|
|
Wake norm area under the curve average by group
|
165.2 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 17.8 • n=5 Participants
|
170.0 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 28.1 • n=7 Participants
|
167.5 mg/(dL/hr) (normalized)
STANDARD_DEVIATION 22.8 • n=5 Participants
|
|
Hypoglycemia percentage of time <70 mg/dL average by group
|
0.4 percentage of time <70 mg/dL
STANDARD_DEVIATION 0.4 • n=5 Participants
|
0.3 percentage of time <70 mg/dL
STANDARD_DEVIATION 0.6 • n=7 Participants
|
0.4 percentage of time <70 mg/dL
STANDARD_DEVIATION 0.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.Double Blinded CGM used for 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.
Outcome measures
| Measure |
Welchol Then Placebo
n=11 Participants
3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
|
Placebo Then Welchol
n=10 Participants
Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
|
|---|---|---|
|
Total Norm AUC Average by Group (Normalized)
Start of Treatment 1
|
150.8 mg/(dL/hr) normalized
Standard Deviation 10.8
|
175.9 mg/(dL/hr) normalized
Standard Deviation 29.2
|
|
Total Norm AUC Average by Group (Normalized)
End of Treatment 1
|
149.9 mg/(dL/hr) normalized
Standard Deviation 17.2
|
175.1 mg/(dL/hr) normalized
Standard Deviation 27.4
|
|
Total Norm AUC Average by Group (Normalized)
Start of Treatment 2
|
163.2 mg/(dL/hr) normalized
Standard Deviation 23.5
|
159.4 mg/(dL/hr) normalized
Standard Deviation 23.9
|
|
Total Norm AUC Average by Group (Normalized)
End of Treatment 2
|
177.9 mg/(dL/hr) normalized
Standard Deviation 33.2
|
159.4 mg/(dL/hr) normalized
Standard Deviation 25.3
|
PRIMARY outcome
Timeframe: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.Overnight glucose captured by CGM.
Outcome measures
| Measure |
Welchol Then Placebo
n=11 Participants
3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
|
Placebo Then Welchol
n=10 Participants
Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
|
|---|---|---|
|
Sleep Norm AUC Average by Group (Normalized)
Start of Treatment 1
|
147.4 mg/(dL/hr) normalized
Standard Deviation 16.6
|
161.9 mg/(dL/hr) normalized
Standard Deviation 25.7
|
|
Sleep Norm AUC Average by Group (Normalized)
End of Treatment 1
|
148.0 mg/(dL/hr) normalized
Standard Deviation 24.0
|
160.2 mg/(dL/hr) normalized
Standard Deviation 27.9
|
|
Sleep Norm AUC Average by Group (Normalized)
Start of Treatment 2
|
158.8 mg/(dL/hr) normalized
Standard Deviation 31.8
|
147.9 mg/(dL/hr) normalized
Standard Deviation 24.4
|
|
Sleep Norm AUC Average by Group (Normalized)
End of Treatment 2
|
172.0 mg/(dL/hr) normalized
Standard Deviation 32.5
|
143.6 mg/(dL/hr) normalized
Standard Deviation 18.6
|
PRIMARY outcome
Timeframe: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.Wake glucose captured by continuous glucose monitoring (CGM).
Outcome measures
| Measure |
Welchol Then Placebo
n=11 Participants
3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
|
Placebo Then Welchol
n=10 Participants
Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
|
|---|---|---|
|
Wake Norm AUC Average by Group (Normalized)
Start of Treatment 1
|
153.3 mg/(dL/hr) (normalized)
Standard Deviation 11.7
|
180.9 mg/(dL/hr) (normalized)
Standard Deviation 32.2
|
|
Wake Norm AUC Average by Group (Normalized)
End of Treatment 1
|
151.2 mg/(dL/hr) (normalized)
Standard Deviation 16.0
|
180.6 mg/(dL/hr) (normalized)
Standard Deviation 29.6
|
|
Wake Norm AUC Average by Group (Normalized)
Start of Treatment 2
|
165.2 mg/(dL/hr) (normalized)
Standard Deviation 21.2
|
163.8 mg/(dL/hr) (normalized)
Standard Deviation 25.6
|
|
Wake Norm AUC Average by Group (Normalized)
End of Treatment 2
|
180.9 mg/(dL/hr) (normalized)
Standard Deviation 34.2
|
165.2 mg/(dL/hr) (normalized)
Standard Deviation 30.5
|
PRIMARY outcome
Timeframe: 2 week periods at the start of treatment 1, end of treatment 1, start of treatment 2, and end of treatment 2.Ambulatory glucose profile (AGP) reports were examined for the changes in the incidence of hypoglycemia (CGM\<70 mg/dL)
Outcome measures
| Measure |
Welchol Then Placebo
n=11 Participants
3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
|
Placebo Then Welchol
n=10 Participants
Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
|
|---|---|---|
|
Hypoglycemia Percentage of Time <70 mg/dL Average by Group
End of Treatment 2
|
0.6 percentage of time <70 mg/dL
Standard Deviation 1.2
|
0.6 percentage of time <70 mg/dL
Standard Deviation 1.1
|
|
Hypoglycemia Percentage of Time <70 mg/dL Average by Group
Start of Treatment 1
|
1.2 percentage of time <70 mg/dL
Standard Deviation 1.3
|
0.3 percentage of time <70 mg/dL
Standard Deviation 0.6
|
|
Hypoglycemia Percentage of Time <70 mg/dL Average by Group
End of Treatment 1
|
0.8 percentage of time <70 mg/dL
Standard Deviation 1.1
|
0.4 percentage of time <70 mg/dL
Standard Deviation 0.6
|
|
Hypoglycemia Percentage of Time <70 mg/dL Average by Group
Start of Treatment 2
|
0.8 percentage of time <70 mg/dL
Standard Deviation 1.2
|
0.7 percentage of time <70 mg/dL
Standard Deviation 1.0
|
Adverse Events
Welchol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place