Trial Outcomes & Findings for Welchol as Monotherapy for Type 2 Diabetes Mellitus (NCT NCT00789737)

NCT ID: NCT00789737

Last Updated: 2014-02-27

Results Overview

change in HbA1c from baseline to Week 24

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 357 participants
• Primary outcome timeframe: 24 week
• Results posted on: 2014-02-27

Participant Flow

From January 2009 through July 2011, subjects were recruited from medical clinics, private practice and research clinics.

There was a 2-week placebo lead-in prior to randomization to treatment arm. Participants were excluded if two or more fasting blood glucose readings >240 mg/dL occurred during lead-in. Subjects were excluded if there had been oral antidiabetic, significant insulin, or bile acid sequestrant therapy in the 3 months prior to screening.

Participant milestones

Measure	Welchol Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo placebo Placebo : placebo
Overall Study STARTED	176	181
Overall Study COMPLETED	128	126
Overall Study NOT COMPLETED	48	55

Reasons for withdrawal

Measure	Welchol Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo placebo Placebo : placebo
Overall Study Withdrawal by Subject	13	22
Overall Study Lost to Follow-up	10	14
Overall Study Adverse Event	8	8
Overall Study Protocol Violation	3	0
Overall Study Lack of Efficacy	3	0
Overall Study hyperglycemia that met protocol-specifie	0	4
Overall Study Other	11	7

Baseline Characteristics

Welchol as Monotherapy for Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Welchol n=176 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=181 Participants placebo Placebo : placebo	Total n=357 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	165 Participants n=5 Participants	167 Participants n=7 Participants	332 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	52.6 years STANDARD_DEVIATION 10.25 • n=5 Participants	51.8 years STANDARD_DEVIATION 10.52 • n=7 Participants	52.2 years STANDARD_DEVIATION 10.38 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	92 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	89 Participants n=7 Participants	183 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	86 Participants n=5 Participants	80 Participants n=7 Participants	166 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants	101 Participants n=7 Participants	191 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	29 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) White	122 Participants n=5 Participants	131 Participants n=7 Participants	253 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	176 participants n=5 Participants	181 participants n=7 Participants	357 participants n=5 Participants
Body mass index	32.0 kg/m*2 STANDARD_DEVIATION 6.5 • n=5 Participants	31.8 kg/m*2 STANDARD_DEVIATION 4.94 • n=7 Participants	31.9 kg/m*2 STANDARD_DEVIATION 5.75 • n=5 Participants
baseline body mass index category <30 kg/m*2	68 participants n=5 Participants	66 participants n=7 Participants	134 participants n=5 Participants
baseline body mass index category >= 30 kg/m*2	108 participants n=5 Participants	115 participants n=7 Participants	223 participants n=5 Participants
Duration of type 2 diabetes	4.3 years STANDARD_DEVIATION 4.69 • n=5 Participants	3.9 years STANDARD_DEVIATION 4.39 • n=7 Participants	4.1 years STANDARD_DEVIATION 4.54 • n=5 Participants

PRIMARY outcome

Timeframe: 24 week

Population: Intent to Treat, Last Observation Carried Forward (LOCF) Some participants may not have had lab results for this specific analysis and therefore excluded.

change in HbA1c from baseline to Week 24

Outcome measures

Measure	Welchol n=175 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=169 Participants placebo Placebo : placebo
Percent Change in Hemoglobin A1c	-0.41 percentage change of hemoglobin A1c Standard Error .091	-0.14 percentage change of hemoglobin A1c Standard Error 0.091

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

to determine changes in Glycemic control after 24 weeks on therapy

Outcome measures

Measure	Welchol n=172 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=166 Participants placebo Placebo : placebo
Change in Fasting Plasma Glucose	-4.6 mg/dL Standard Error 3.45 • Interval -19.96 to	5.7 mg/dL Standard Error 3.51

SECONDARY outcome

Timeframe: 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.

Outcome measures

Measure	Welchol n=175 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=169 Participants placebo Placebo : placebo
% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units	33.1 percentage of participants	19.5 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

% Subjects achieving an HbA1C goal of <7.0 at 24 weeks

Outcome measures

Measure	Welchol n=175 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=169 Participants placebo Placebo : placebo
% Subjects Achieving an HbA1C Goal of <7.0	20.0 percentage of participants	13.6 percentage of participants

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks

Outcome measures

Measure	Welchol n=175 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=169 Participants placebo Placebo : placebo
% Subjects With a Decrease in FPG >=30 mg/dL	26.9 percentage of participants	17.8 percentage of participants

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

To assess the effects of Welchol on changes in total cholesterol [TC]

Outcome measures

Measure	Welchol n=164 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=160 Participants placebo Placebo : placebo
Changes in Total Cholesterol [TC]	-3.3 mg/dL Standard Error 1.02	1.8 mg/dL Standard Error 1.03

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]

Outcome measures

Measure	Welchol n=162 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=160 Participants placebo Placebo : placebo
Changes in Low Density Lipoprotein Cholesterol [LDL-C]	-10.0 mg/dL Standard Error 1.62	1.2 mg/dL Standard Error 1.63

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]

Outcome measures

Measure	Welchol n=164 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=160 Participants placebo Placebo : placebo
Changes in High Density Lipoprotein Cholesterol [HDL-C]	1.7 md/dL Standard Error 1.19	-0.1 md/dL Standard Error 1.21

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

To assess the effects of Welchol on changes in non-HDL-C

Outcome measures

Measure	Welchol n=164 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=160 Participants placebo Placebo : placebo
Changes in Non-HDL-C	-4.4 mg/dL Standard Error 1.34	3.0 mg/dL Standard Error 1.36

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

To assess the effects of Welchol on changes in triglycerides [TG]

Outcome measures

Measure	Welchol n=164 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=160 Participants placebo Placebo : placebo
Changes in Triglycerides [TG]	15.5 mg/dL Standard Error 39.82	5.8 mg/dL Standard Error 38.39

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)

Outcome measures

Measure	Welchol n=164 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=160 Participants placebo Placebo : placebo
Changes in Apolipoprotein A-I (apoA-I)	3.2 mg/dL Standard Error 0.80	0.9 mg/dL Standard Error 0.81

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

To assess the effects of Welchol on changes in apolipoprotein B (apoB)

Outcome measures

Measure	Welchol n=164 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=160 Participants placebo Placebo : placebo
Changes in Apolipoprotein B (apoB)	-5.6 mg/dL Standard Error 1.18	0.9 mg/dL Standard Error 1.19

SECONDARY outcome

Timeframe: from baseline to 24 weeks

Population: Some participants may not have had lab results for this specific analysis and therefore excluded.

To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test

Outcome measures

Measure	Welchol n=131 Participants Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=125 Participants placebo Placebo : placebo
Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test	-9.3 mg/dL Standard Error 5.72	-1.5 mg/dL Standard Error 5.86

Adverse Events

Welchol

Serious events: 7 serious events

Other events: 91 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 77 other events

Deaths: 0 deaths

Serious adverse events

Measure	Welchol n=175 participants at risk Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=171 participants at risk placebo Placebo : placebo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ovarian adenoma	0.00% 0/175 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Vascular disorders hypotension	0.00% 0/175 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Psychiatric disorders suicide attempt	0.00% 0/175 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Musculoskeletal and connective tissue disorders tibia fracture	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Psychiatric disorders depression	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Psychiatric disorders psychotic disorder	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Injury, poisoning and procedural complications alcohol poisoning	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Vascular disorders coronary artery disease	1.1% 2/175 • Number of events 2 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Cardiac disorders acute myocardial infarction	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Respiratory, thoracic and mediastinal disorders pneumonia	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Hepatobiliary disorders liver function test abnormal	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Hepatobiliary disorders bilirubin increased	0.57% 1/175 • Number of events 2 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Renal and urinary disorders pyelonephritis	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.00% 0/171 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.

Other adverse events

Measure	Welchol n=175 participants at risk Welchol 625mg tablets Welchol : Welchol 625mg tablets	Placebo n=171 participants at risk placebo Placebo : placebo
Gastrointestinal disorders constipation	3.4% 6/175 • Number of events 6 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	1.8% 3/171 • Number of events 3 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Gastrointestinal disorders diarrhoea	4.0% 7/175 • Number of events 7 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	1.8% 3/171 • Number of events 3 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Gastrointestinal disorders gastrooesophageal reflux disease	2.3% 4/175 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Infections and infestations bronchitis	1.1% 2/175 • Number of events 2 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	2.3% 4/171 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Infections and infestations nasopharyngitis	1.1% 2/175 • Number of events 2 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	5.3% 9/171 • Number of events 9 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Infections and infestations tooth abcess	2.3% 4/175 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Infections and infestations upper respiratory tract infection	3.4% 6/175 • Number of events 6 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	1.2% 2/171 • Number of events 2 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Infections and infestations urinary tract infection	4.0% 7/175 • Number of events 7 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	8.8% 15/171 • Number of events 15 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Investigations aspartate aminotransferase increased	2.3% 4/175 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	1.2% 2/171 • Number of events 2 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Investigations blood creatine phosphokinase increased	2.3% 4/175 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Investigations c-reactive protein increased	3.4% 6/175 • Number of events 6 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	2.3% 4/171 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Metabolism and nutrition disorders diabetes mellitus	2.9% 5/175 • Number of events 5 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	3.5% 6/171 • Number of events 6 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Metabolism and nutrition disorders hyperglycaemia	2.9% 5/175 • Number of events 5 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	1.8% 3/171 • Number of events 3 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Metabolism and nutrition disorders hypoglycaemia	4.0% 7/175 • Number of events 7 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Metabolism and nutrition disorders hypokalaemia	0.00% 0/175 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	2.3% 4/171 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Musculoskeletal and connective tissue disorders arthralgia	2.3% 4/175 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	1.8% 3/171 • Number of events 3 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Musculoskeletal and connective tissue disorders back pain	5.1% 9/175 • Number of events 9 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	0.58% 1/171 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Musculoskeletal and connective tissue disorders pain in extremity	1.7% 3/175 • Number of events 3 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	2.3% 4/171 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Nervous system disorders dizziness	2.3% 4/175 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	2.3% 4/171 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Nervous system disorders headache	4.6% 8/175 • Number of events 8 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	2.9% 5/171 • Number of events 5 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Respiratory, thoracic and mediastinal disorders cough	2.3% 4/175 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	2.3% 4/171 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Vascular disorders hypertension	2.3% 4/175 • Number of events 4 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	1.2% 2/171 • Number of events 2 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.
Gastrointestinal disorders nausea	0.57% 1/175 • Number of events 1 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.	2.9% 5/171 • Number of events 5 • January 2009 through December 2011 Each visit and phone contact included questions to discover adverse events. The Safety Data Set (Welchol 175 Placebo 171) contains fewer subjects than the Overall Data Set (Welchol 176 Placebo 181) due to the Safety Data Set only includes subjects who took at least 1 dose of study medication and and have at least 1 post-baseline safety measure.

Additional Information

Director Metabolic Clinical Development

Daiichi Sankyo Pharma Development

Phone: 732-590-5000

Results disclosure agreements

• Principal investigator is a sponsor employee Until coordinated multicenter publication or one year after the study termination, whichever occurs first. After that, submit for Daiichi Sankyo, Inc. (DSI) review and comment at least 45 days before submission. DSI may ask up to 60 additional days, if patentable material is identified.
• Publication restrictions are in place

Restriction type: OTHER