Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Colesevelam for Children With Type 2 Diabetes (WELKid DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01258075
Recruitment Status : Completed
First Posted : December 10, 2010
Results First Posted : December 22, 2020
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: High-dose colesevelam
Drug: Low-dose colesevelam
Enrollment 236
Recruitment Details 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).
Pre-assignment Details 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.
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner. Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
Period Title: Overall Study
Started 141 95
Completed 99 72
Not Completed 42 23
Reason Not Completed
Adverse Event             8             3
Lost to Follow-up             11             6
Withdrawal by Subject             10             7
Hyperglycemia meeting protocol-specified discontinuation criteria             1             2
Other             12             5
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose) Total
Hide Arm/Group Description Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner. Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner. Total of all reporting groups
Overall Number of Baseline Participants 141 95 236
Hide Baseline Analysis Population Description
Baseline demographic characteristics were assessed in the Randomized Set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants 95 participants 236 participants
14.1  (2.09) 14.2  (2.02) 14.2  (2.06)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 95 participants 236 participants
10-13 years
51
  36.2%
33
  34.7%
84
  35.6%
14-17 years
90
  63.8%
62
  65.3%
152
  64.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 95 participants 236 participants
Female
114
  80.9%
67
  70.5%
181
  76.7%
Male
27
  19.1%
28
  29.5%
55
  23.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 95 participants 236 participants
American Indian or Alaska Native
0
   0.0%
1
   1.1%
1
   0.4%
Asian
4
   2.8%
3
   3.2%
7
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.1%
1
   0.4%
Black or African American
49
  34.8%
38
  40.0%
87
  36.9%
White
71
  50.4%
46
  48.4%
117
  49.6%
More than one race
15
  10.6%
5
   5.3%
20
   8.5%
Unknown or Not Reported
2
   1.4%
1
   1.1%
3
   1.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 141 participants 95 participants 236 participants
141 95 236
1.Primary Outcome
Title Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
Hide Description 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.
Time Frame Baseline to Month 6 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Change in HbA1c levels were assessed in the Intent-to-Treat population.
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description:
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
Overall Number of Participants Analyzed 132 88
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
0.09
(-0.18 to 0.36)
0.21
(-0.11 to 0.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Welchol 3.75 g (High-dose), Welchol 0.625 g (Low-dose)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5494
Comments [Not Specified]
Method ANCOVA
Comments Based on a mixed effect ANCOVA model with treatment and previous type 2 diabetes treatment stratum as fixed effects and baseline as a covariate.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.54 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.210
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
Hide Description 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.
Time Frame Baseline to Month 12 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description:
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
Overall Number of Participants Analyzed 122 83
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
Month 3 Number Analyzed 122 participants 83 participants
-0.27
(-0.49 to -0.06)
-0.05
(-0.31 to 0.22)
Month 6 Number Analyzed 93 participants 62 participants
-0.12
(-0.38 to 0.14)
-0.06
(-0.37 to 0.26)
Month 9 Number Analyzed 65 participants 38 participants
-0.06
(-0.42 to 0.30)
-0.16
(-0.61 to 0.30)
Month 12 Number Analyzed 52 participants 32 participants
-0.31
(-0.61 to -0.01)
-0.38
(-0.76 to 0.01)
Month 12/Early termination Number Analyzed 70 participants 40 participants
-0.19
(-0.54 to 0.15)
-0.10
(-0.55 to 0.35)
3.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
Hide Description Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points.
Time Frame Baseline to Month 12 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FPG values were assessed in the Intent-to-Treat population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description:
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
Overall Number of Participants Analyzed 90 61
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
Month 6 Number Analyzed 90 participants 61 participants
11.6
(1.8 to 21.4)
16.7
(4.7 to 28.7)
Month 12 Number Analyzed 44 participants 27 participants
15.5
(2.9 to 28.1)
10.6
(-5.8 to 27.0)
Month 12/Early termination Number Analyzed 50 participants 27 participants
14.6
(2.9 to 26.4)
11.6
(-4.5 to 27.7)
4.Secondary Outcome
Title Number of Participants Achieving a Response to Therapy to Month 12
Hide Description 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.
Time Frame Baseline to Month 12 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Response to therapy was assessed in the Intent-to-Treat population.
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description:
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
Overall Number of Participants Analyzed 132 88
Measure Type: Count of Participants
Unit of Measure: Participants
Month 6 (LOCF): Achieving HBA1C <7%
39
  29.5%
26
  29.5%
Month 6 (LOCF): Achieving HBA1C <6.5%
26
  19.7%
11
  12.5%
Month 6 (LOCF): Achieving a reduction in HBA1C of ≥0.7%
32
  24.2%
20
  22.7%
Month 6 (LOCF): Achieving a reduction in HBA1C of ≥0.5%
44
  33.3%
32
  36.4%
Month 6 (LOCF): Achieving a reduction in FPG ≥30 mg/dL
17
  12.9%
10
  11.4%
Reduction in HBA1C of ≥0.7% and/or in FPG of ≥30 mg/dL from baseline to Month 6 with & without LOCF
37
  28.0%
25
  28.4%
Reduction in HBA1C of ≥0.5% and/or in FPG of ≥30 mg/dL from baseline to Month 6 with & without LOCF
49
  37.1%
36
  40.9%
Month 12: Achieving HBA1C <7%
26
  19.7%
18
  20.5%
Month 12: Achieving HBA1C <6.5%
19
  14.4%
8
   9.1%
Month 12: Achieving a reduction in HBA1C of ≥0.7%
15
  11.4%
11
  12.5%
Month 12: Achieving a reduction in HBA1C of ≥0.5%
19
  14.4%
16
  18.2%
Month 12: Achieving a reduction in FPG ≥30 mg/dL
4
   3.0%
0
   0.0%
Reduction in HBA1C of ≥0.7% and/or in FPG of ≥30 mg/dL from baseline to Month 12
15
  11.4%
11
  12.5%
Reduction in HBA1C of ≥0.5% and/or in FPG of ≥30 mg/dL from baseline to Month 12
19
  14.4%
16
  18.2%
Month 12/Early termination: Achieving HBA1C <7%
33
  25.0%
19
  21.6%
Month 12/Early termination: Achieving HBA1C <6.5%
21
  15.9%
8
   9.1%
Month 12/Early termination: Achieving a reduction in HBA1C of ≥0.7%
20
  15.2%
13
  14.8%
Month 12/Early termination: Achieving a reduction in HBA1C of ≥0.5%
27
  20.5%
18
  20.5%
Month 12/Early termination: Achieving a reduction in FPG ≥30 mg/dL
5
   3.8%
0
   0.0%
Reduction in HBA1C of ≥0.7% and/or in FPG of ≥30 mg/dL from baseline to Month 12/Early termination
21
  15.9%
13
  14.8%
Reduction in HBA1C of ≥0.5% and/or in FPG of ≥30 mg/dL from baseline to Month 12/Early termination
28
  21.2%
18
  20.5%
5.Secondary Outcome
Title Percent Change From Baseline to Month 6 in Plasma Lipids
Hide Description 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.
Time Frame Baseline to Month 6 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description:
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
Overall Number of Participants Analyzed 117 77
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
Total cholesterol Number Analyzed 117 participants 77 participants
1.0
(-1.3 to 3.4)
3.2
(0.3 to 6.1)
Low-density lipoprotein cholesterol Number Analyzed 115 participants 76 participants
-1.1
(-4.7 to 2.4)
4.4
(0 to 8.8)
High-density lipoprotein cholesterol Number Analyzed 117 participants 77 participants
1.9
(-0.8 to 4.7)
2.3
(-1.1 to 5.7)
Non-High-density lipoprotein cholesterol Number Analyzed 117 participants 77 participants
1.2
(-1.9 to 4.2)
4.1
(0.4 to 7.8)
Apolipoprotein A-1 Number Analyzed 117 participants 77 participants
2.3
(0.2 to 4.5)
3.1
(0.4 to 5.7)
Apolipoprotein B Number Analyzed 117 participants 77 participants
0.8
(-2.0 to 3.5)
2.7
(-0.7 to 6.2)
6.Secondary Outcome
Title Percent Change From Baseline to Month 6 in Triglycerides
Hide Description 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.
Time Frame Baseline to Month 6 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Triglyceride values were assessed in the Intent-to-Treat population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description:
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
Overall Number of Participants Analyzed 117 77
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
10.0
(2.8 to 17.8)
6.4
(-3.8 to 15.8)
7.Secondary Outcome
Title Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
Hide Description 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.
Time Frame Baseline to Month 12 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants meeting rescue criteria were assessed in the Intent-to-Treat population.
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description:
Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner.
Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
Overall Number of Participants Analyzed 132 88
Measure Type: Count of Participants
Unit of Measure: Participants
Met rescue criteria 1 time
16
  12.1%
8
   9.1%
Took rescue medication after meeting criteria 1 time
4
   3.0%
0
   0.0%
Did not take rescue medication after meeting criteria 1 time
12
   9.1%
8
   9.1%
Met rescue criteria 2 times
18
  13.6%
5
   5.7%
Took rescue medication after meeting criteria 2 times
12
   9.1%
3
   3.4%
Did not take rescue medication after meeting criteria 2 times
6
   4.5%
2
   2.3%
Met rescue criteria >2 times
50
  37.9%
45
  51.1%
Took rescue medication after meeting criteria >2 times
43
  32.6%
42
  47.7%
Did not take rescue medication after meeting criteria >2 times
7
   5.3%
3
   3.4%
Initially met rescue criteria at Month 3 to <Month 6
25
  18.9%
19
  21.6%
Initially met rescue criteria at Month 6 to <Month 9
41
  31.1%
29
  33.0%
Initially met rescue criteria at Month 9 to <Month 12
9
   6.8%
6
   6.8%
Initially met rescue criteria at >Month 12
9
   6.8%
4
   4.5%
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Hide Arm/Group Description Participants who were randomized to receive Welchol 3.75 g (high-dose) suspended in a drink for oral administration once daily with dinner. Participants who were randomized to receive Welchol 0.625 g (low-dose) suspended in a drink for oral administration once daily with dinner.
All-Cause Mortality
Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/141 (0.00%)   0/95 (0.00%) 
Hide Serious Adverse Events
Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/141 (7.09%)   9/95 (9.47%) 
Cardiac disorders     
Tachycardia  1  1/141 (0.71%)  0/95 (0.00%) 
Eye disorders     
Vision blurred  1  1/141 (0.71%)  0/95 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/141 (0.00%)  1/95 (1.05%) 
Infections and infestations     
Cellulitis  1  0/141 (0.00%)  1/95 (1.05%) 
Appendicitis  1  2/141 (1.42%)  0/95 (0.00%) 
Injury, poisoning and procedural complications     
Intentional overdose  1  0/141 (0.00%)  1/95 (1.05%) 
Ankle fracture  1  0/141 (0.00%)  1/95 (1.05%) 
Fall  1  1/141 (0.71%)  0/95 (0.00%) 
Ankle fracture  1  1/141 (0.71%)  0/95 (0.00%) 
Fibula fracture  1  1/141 (0.71%)  0/95 (0.00%) 
Procedural hypertension  1  1/141 (0.71%)  0/95 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycemia  1  0/141 (0.00%)  1/95 (1.05%) 
Diabetic ketoacidosis  1  1/141 (0.71%)  0/95 (0.00%) 
Nervous system disorders     
Headache  1  1/141 (0.71%)  0/95 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Intra-uterine death  1  0/141 (0.00%)  1/95 (1.05%) 
Premature labor  1  0/141 (0.00%)  1/95 (1.05%) 
Abortion spontaneous  1  0/141 (0.00%)  1/95 (1.05%) 
Psychiatric disorders     
Affective disorder  1  0/141 (0.00%)  1/95 (1.05%) 
Abnormal behavior  1  0/141 (0.00%)  1/95 (1.05%) 
Conversion disorder  1  0/141 (0.00%)  1/95 (1.05%) 
Suicidal ideation  1  2/141 (1.42%)  0/95 (0.00%) 
Depression  1  2/141 (1.42%)  0/95 (0.00%) 
Drug abuse  1  1/141 (0.71%)  0/95 (0.00%) 
Suicide attempt  1  1/141 (0.71%)  0/95 (0.00%) 
Aggression  1  1/141 (0.71%)  0/95 (0.00%) 
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Welchol 3.75 g (High-dose) Welchol 0.625 g (Low-dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   85/141 (60.28%)   51/95 (53.68%) 
Gastrointestinal disorders     
Abdominal pain  1  8/141 (5.67%)  4/95 (4.21%) 
Abdominal pain upper  1  12/141 (8.51%)  9/95 (9.47%) 
Constipation  1  10/141 (7.09%)  1/95 (1.05%) 
Diarrhea  1  13/141 (9.22%)  10/95 (10.53%) 
Nausea  1  8/141 (5.67%)  7/95 (7.37%) 
Vomiting  1  20/141 (14.18%)  11/95 (11.58%) 
General disorders     
Pyrexia  1  7/141 (4.96%)  5/95 (5.26%) 
Infections and infestations     
Upper respiratory tract infection  1  24/141 (17.02%)  9/95 (9.47%) 
Urinary tract infection  1  7/141 (4.96%)  6/95 (6.32%) 
Nasopharyngitis  1  10/141 (7.09%)  8/95 (8.42%) 
Injury, poisoning and procedural complications     
Joint sprain  1  3/141 (2.13%)  6/95 (6.32%) 
Metabolism and nutrition disorders     
Hyperglycemia  1  18/141 (12.77%)  14/95 (14.74%) 
Nervous system disorders     
Headache  1  17/141 (12.06%)  8/95 (8.42%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/141 (7.09%)  6/95 (6.32%) 
Oropharyngeal pain  1  10/141 (7.09%)  10/95 (10.53%) 
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Contact of Clinical Trial Information
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01258075    
Other Study ID Numbers: WEL-A-U307
First Submitted: December 9, 2010
First Posted: December 10, 2010
Results First Submitted: November 25, 2020
Results First Posted: December 22, 2020
Last Update Posted: May 13, 2021