Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, Blood glucose, Anti-diabetic, Bile acid sequestrant, Colesevelam HCl, Oral suspension, Pediatric, Add-on therapy, Add-on to metformin, Metformin, Adolescent, Lipid
Brief summary
This study will evaluate the efficacy and safety of the study drug in treating type 2 diabetes in children 10 to 17 years old. The groups will be low-dose (0.625 g Welchol) and high-dose (3.75 g Welchol). The children will have a 2 in 5 chance of being assigned to the low-dose group. They will have a 3 in 5 chance of being assigned to the high-dose group. We believe the study drug will be safe, well tolerated, and improve blood sugar control in children 10 to 17 years old.
Detailed description
Colesevelam oral suspension will be studied as treatment of type 2 diabetes mellitus (T2DM) to evaluate clinical safety and efficacy in patients aged 10-17 years. The patients may have been treated with Metformin or have had no antidiabetic drug treatment in the previous three months. Study Hypothesis: Colesevelam oral suspension for pediatric subjects with T2DM is safe, well tolerated, and shows improved blood sugar control (as evidenced by a significant change from baseline in hemoglobin A1C \[HbA1c\]).
Interventions
DRUGHigh-dose colesevelam
3.75 grams colesevelam hydrochloride in oral suspension
DRUGLow-dose colesevelam
0.625 grams colesevelam hydrochloride in oral suspension
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes mellitus, as defined by the American Diabetes Association; * Written informed consent of study participation * Males and females aged 10 to 17 years, inclusive, at randomization (randomization must occur before 18th birthday); * HbA1c at screening between 7.0% and 10.0%, inclusive; * Fasting C-peptide \>0.6 ng/mL; and * Anti-diabetic treatment at screening: * Treatment-naïve or untreated; OR * On metformin monotherapy: Metformin monotherapy has been initiated prior to screening.
Exclusion criteria
* Fasting plasma glucose \>270 mg/dL; * Diagnosis of type 1 diabetes; * History of more than one episode of ketoacidosis after the initial diagnosis of type 2 diabetes mellitus; * Clinical laboratory assessments/evaluations, eg. autoimmune markers, aminotransferases, triglycerides, creatinine clearance, and Hb variants, that are not within the protocol-defined parameters * Systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg * Use of medications not allowed by protocol-defined parameters, eg. insulin or any medication that affects insulin sensitivity or secretion, growth hormones/somatotropin, or anabolic steroids * Genetic syndrome or disorder known to affect glucose * Participation in a weight loss program or another interventional research study within 60 days; * Female participants who are lactating, pregnant, or plan to become pregnant within 1 year of screening; * Female participants who are sexually active and unwilling to use appropriate contraception for the duration of the study; * History of bowel obstruction; * Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the Investigator, would prevent full participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6 | Baseline to Month 6 post-dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 | Baseline to Month 12 post-dose | Change from baseline was assessed for FPG values at Month 6 and Month 12 categorical time points. |
| Number of Participants Achieving a Response to Therapy to Month 12 | Baseline to Month 12 post-dose | 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. |
| Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Baseline to Month 12 post-dose | 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. |
| Percent Change From Baseline to Month 6 in Triglycerides | Baseline to Month 6 post-dose | 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. |
| Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Baseline to Month 12 post-dose | 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. |
| Percent Change From Baseline to Month 6 in Plasma Lipids | Baseline to Month 6 post-dose | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 141 |
| 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. | 95 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 3 |
| Overall Study | Hyperglycemia meeting protocol-specified discontinuation criteria | 1 | 2 |
| Overall Study | Lost to Follow-up | 11 | 6 |
| Overall Study | Other | 12 | 5 |
| Overall Study | Withdrawal by Subject | 10 | 7 |
Baseline characteristics
| Characteristic | Welchol 3.75 g (High-dose) | Welchol 0.625 g (Low-dose) | Total |
|---|---|---|---|
| Age, Continuous | 14.1 years STANDARD_DEVIATION 2.09 | 14.2 years STANDARD_DEVIATION 2.02 | 14.2 years STANDARD_DEVIATION 2.06 |
| Age, Customized 10-13 years | 51 Participants | 33 Participants | 84 Participants |
| Age, Customized 14-17 years | 90 Participants | 62 Participants | 152 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 38 Participants | 87 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 5 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 71 Participants | 46 Participants | 117 Participants |
| Region of Enrollment United States | 141 participants | 95 participants | 236 participants |
| Sex: Female, Male Female | 114 Participants | 67 Participants | 181 Participants |
| Sex: Female, Male Male | 27 Participants | 28 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 141 | 0 / 95 |
| other Total, other adverse events | 85 / 141 | 51 / 95 |
| serious Total, serious adverse events | 10 / 141 | 9 / 95 |
Outcome results
Primary
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6
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
Population: Change in HbA1c levels were assessed in the Intent-to-Treat population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Welchol 3.75 g (High-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6 | 0.09 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 6 | 0.21 percent change |
p-value: 0.549495% CI: [-0.54, 0.29]ANCOVA
Secondary
Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12
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
Population: FPG values were assessed in the Intent-to-Treat population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Welchol 3.75 g (High-dose) | Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 | Month 6 | 11.6 mg/dL |
| Welchol 3.75 g (High-dose) | Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 | Month 12 | 15.5 mg/dL |
| Welchol 3.75 g (High-dose) | Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 | Month 12/Early termination | 14.6 mg/dL |
| Welchol 0.625 g (Low-dose) | Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 | Month 6 | 16.7 mg/dL |
| Welchol 0.625 g (Low-dose) | Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 | Month 12 | 10.6 mg/dL |
| Welchol 0.625 g (Low-dose) | Change in Fasting Plasma Glucose (FPG) From Baseline to Month 12 | Month 12/Early termination | 11.6 mg/dL |
Secondary
Number of Participants Achieving a Response to Therapy to Month 12
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
Population: Response to therapy was assessed in the Intent-to-Treat population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving a reduction in HBA1C of ≥0.5% | 19 Participants |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving a reduction in FPG ≥30 mg/dL | 4 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving HBA1C <6.5% | 26 Participants |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving a reduction in HBA1C of ≥0.5% | 44 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12/Early termination: Achieving HBA1C <7% | 33 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12/Early termination: Achieving HBA1C <6.5% | 21 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving HBA1C <7% | 26 Participants |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving HBA1C <7% | 39 Participants |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving HBA1C <6.5% | 19 Participants |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving a reduction in FPG ≥30 mg/dL | 17 Participants |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving a reduction in HBA1C of ≥0.7% | 15 Participants |
| Welchol 3.75 g (High-dose) | 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 |
| Welchol 3.75 g (High-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving a reduction in HBA1C of ≥0.7% | 32 Participants |
| Welchol 0.625 g (Low-dose) | 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 | 18 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving HBA1C <7% | 26 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving HBA1C <6.5% | 11 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving a reduction in HBA1C of ≥0.7% | 20 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving a reduction in HBA1C of ≥0.5% | 32 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 6 (LOCF): Achieving a reduction in FPG ≥30 mg/dL | 10 Participants |
| Welchol 0.625 g (Low-dose) | 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 | 25 Participants |
| Welchol 0.625 g (Low-dose) | 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 | 36 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving HBA1C <7% | 18 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving HBA1C <6.5% | 8 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving a reduction in HBA1C of ≥0.7% | 11 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving a reduction in HBA1C of ≥0.5% | 16 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12: Achieving a reduction in FPG ≥30 mg/dL | 0 Participants |
| Welchol 0.625 g (Low-dose) | 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 | 11 Participants |
| Welchol 0.625 g (Low-dose) | 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 | 16 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12/Early termination: Achieving HBA1C <6.5% | 8 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12/Early termination: Achieving a reduction in HBA1C of ≥0.7% | 13 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12/Early termination: Achieving a reduction in HBA1C of ≥0.5% | 18 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12/Early termination: Achieving a reduction in FPG ≥30 mg/dL | 0 Participants |
| Welchol 0.625 g (Low-dose) | 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 | 13 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Achieving a Response to Therapy to Month 12 | Month 12/Early termination: Achieving HBA1C <7% | 19 Participants |
Secondary
Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria
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
Population: Participants meeting rescue criteria were assessed in the Intent-to-Treat population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Did not take rescue medication after meeting criteria 1 time | 12 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Took rescue medication after meeting criteria >2 times | 43 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Took rescue medication after meeting criteria 2 times | 12 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Did not take rescue medication after meeting criteria >2 times | 7 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Took rescue medication after meeting criteria 1 time | 4 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Initially met rescue criteria at Month 3 to <Month 6 | 25 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Did not take rescue medication after meeting criteria 2 times | 6 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Initially met rescue criteria at Month 6 to <Month 9 | 41 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Met rescue criteria 2 times | 18 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Initially met rescue criteria at Month 9 to <Month 12 | 9 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Met rescue criteria >2 times | 50 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Initially met rescue criteria at >Month 12 | 9 Participants |
| Welchol 3.75 g (High-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Met rescue criteria 1 time | 16 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Initially met rescue criteria at >Month 12 | 4 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Met rescue criteria 1 time | 8 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Took rescue medication after meeting criteria 1 time | 0 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Did not take rescue medication after meeting criteria 1 time | 8 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Met rescue criteria 2 times | 5 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Took rescue medication after meeting criteria 2 times | 3 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Did not take rescue medication after meeting criteria 2 times | 2 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Met rescue criteria >2 times | 45 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Took rescue medication after meeting criteria >2 times | 42 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Did not take rescue medication after meeting criteria >2 times | 3 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Initially met rescue criteria at Month 3 to <Month 6 | 19 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Initially met rescue criteria at Month 6 to <Month 9 | 29 Participants |
| Welchol 0.625 g (Low-dose) | Number of Participants Requiring Rescue Medication Who Initially Met Rescue Criteria | Initially met rescue criteria at Month 9 to <Month 12 | 6 Participants |
Secondary
Percent Change From Baseline to Month 6 in Plasma Lipids
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Welchol 3.75 g (High-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Total cholesterol | 1.0 percent change |
| Welchol 3.75 g (High-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Low-density lipoprotein cholesterol | -1.1 percent change |
| Welchol 3.75 g (High-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | High-density lipoprotein cholesterol | 1.9 percent change |
| Welchol 3.75 g (High-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Non-High-density lipoprotein cholesterol | 1.2 percent change |
| Welchol 3.75 g (High-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Apolipoprotein A-1 | 2.3 percent change |
| Welchol 3.75 g (High-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Apolipoprotein B | 0.8 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Apolipoprotein A-1 | 3.1 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Total cholesterol | 3.2 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Non-High-density lipoprotein cholesterol | 4.1 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Low-density lipoprotein cholesterol | 4.4 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | Apolipoprotein B | 2.7 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change From Baseline to Month 6 in Plasma Lipids | High-density lipoprotein cholesterol | 2.3 percent change |
Secondary
Percent Change From Baseline to Month 6 in Triglycerides
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
Population: Triglyceride values were assessed in the Intent-to-Treat population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Welchol 3.75 g (High-dose) | Percent Change From Baseline to Month 6 in Triglycerides | 10.0 mg/dL |
| Welchol 0.625 g (Low-dose) | Percent Change From Baseline to Month 6 in Triglycerides | 6.4 mg/dL |
Secondary
Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12
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
Population: 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 | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Welchol 3.75 g (High-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 6 | -0.12 percent change |
| Welchol 3.75 g (High-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 12 | -0.31 percent change |
| Welchol 3.75 g (High-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 9 | -0.06 percent change |
| Welchol 3.75 g (High-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 12/Early termination | -0.19 percent change |
| Welchol 3.75 g (High-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 3 | -0.27 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 12/Early termination | -0.10 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 3 | -0.05 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 6 | -0.06 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 9 | -0.16 percent change |
| Welchol 0.625 g (Low-dose) | Percent Change in Hemoglobin A1c (HbA1c) From Baseline to Month 12 | Month 12 | -0.38 percent change |