Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes Type II
Brief summary
This study evaluates the effect of medicines for type 2 diabetes and lipids control. This study will require about 6 office visits for lab tests and examinations. All study related medicines and medical examinations will be provided at no cost to the subjects.
Interventions
DRUGGSK523338
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis type 2 diabetes mellitus. * Women must not be pregnant or breastfeeding during the study and 30 days after the study. * Must sign an informed consent form at the study clinic.
Exclusion criteria
* Severe chronic diseases that would prevent from participating and completing the study by investigator's judgement. * Use of an investigational drug within 30 days or 5 half lives before first dose of study medication. * Insulin use for \> 1 week in past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy | Baseline (Week 0) and Week 6 | Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Percent Change From Baseline to Week 6 in LDL-c | Baseline (Week 0) and Week 6 | Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. |
| Mean Change From Baseline to Week 16 in HbA1c | Baseline (Week 0) and Week 16 | Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. |
| Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | Baseline (Week 0) and Week 16 | Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. |
| Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6 | Week 6 | Number of participants achieving American Diabetes Association (ADA) target of LDL\<100 mg/dL (2.59 mmol/L) at Week 6 was compared between the FDC groups and the all SIMV group using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model. |
| Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16 | Up to Week 16 | Number of participants achieving ADA target of HbA1c \< 7.0% or reduction of HbA1c ≥ 0.7% at Week 16 was compared between the FDC groups and the RSG groups groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model. |
| Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy | Baseline (Week 0) and Week 16 | Mean change from Baseline to Week 16 in HbA1c in FDC and SIMV monotherapy was reported. Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of ANCOVA with terms for treatment, gender, current sulfonylurea use (at Baseline), country, and Baseline measurement. |
| On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Up to Week 16 | The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (\<85 and \>160 millimeter of mercury \[mmHg\]), diastolic blood pressure (\<45 and \>100 mmHg) and heart rate (\<40 and \>110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported. |
| On-Therapy Change From Baseline in Body Weight | Up to Week 16 | Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. Change from Baseline was computed as: Visit value - Baseline Value. |
| Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Up to Week 16 | Urine samples were observed for red blood cells and white blood cells. the results were reported as cells per high-power field (cells/HPF). The number of participants with cells in urine were reported. |
| Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Up to Week 16 | AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Up to Week 16 | The clinical chemistry parameters analyzed were sodium, potassium, bicarbonate, chloride, calcium, total protein, albumin, creatinine total bilirubin, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and alkaline phosphatase. The hematology parameters analyzed were hemoglobin, hematocrit, platelet count, total white cell count. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported. |
| Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 | Week 16 | Number of participants achieving ADA target of FPG\< 126 mg/dL (7.0 mmol/L) or reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 was compared between the all SIM monotherapy group and the all FDC RSG/SIMV groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model. |
Countries
Australia, Canada, Mexico, Philippines, Puerto Rico, United States
Participant flow
Recruitment details
The study was conducted between 17 April 2005 and 21 December 2006 at 68 centers in five countries including United States, Canada, Australia, Mexico, and the Philippines. A total of 370 participants were randomized of which 1 participant did not received study medication remaining 369 participants were included in safety population.
Pre-assignment details
Out of the 369 participants from safety population, 12 participants received at least one dose but did not have at least one On-Therapy value for any efficacy assessment, the remaining 357 participants were included in Intent- to-Treat population.
Participants by arm
| Arm | Count |
|---|---|
| FDC RSG/SIMV 4/40 mg Participants received FDC RSG/SIMV 4/40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL at Visit 4a (Week 6), the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg once a day from Week 6 till Week 16. | 47 |
| FDC RSG/SIMV 4/80 mg Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks. | 44 |
| FDC RSG/SIMV 8/40 mg Participants received FDC RSG/SIMV 8/40 mg once a day and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 8/40 mg and SIMV 40 mg once a day from Week 6 till Week 16. | 45 |
| FDC RSG/SIMV 8/80 mg Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. | 46 |
| RSG 4mg Participants received RSG 4.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL evaluated at Visit 4a (Week 6), the treatment doses were titrated up to RSG/SIMV 4/40 mg once a day from Week 6 till Week 16. | 48 |
| RSG 8mg Participants received RSG 8.0 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to RSG/SIMV 8/40 mg once a day from Week 6 till Week 16. | 46 |
| SIMV 40mg Participants received SIMV 40 mg and matching placebo once a day for 16 weeks. In case of the participants who had LDL-c \>130 mg/dL at Visit 4a (Week 6) the treatment doses were up titrated to SIMV/SIMV 40/40 mg once a day from Week 6 till Week 16. | 46 |
| SIMV 80mg Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. | 47 |
| Total | 369 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 | 1 | 2 | 2 | 1 | 4 |
| Overall Study | Fasting plasma glucose >240 mg/dL | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Glycemia over 13.3 millimole per litre | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Investigator's Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 2 | 3 | 2 | 0 | 1 | 2 |
| Overall Study | Non-compliance with study medication | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Participant out of assessment window | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Participant travelled Overseas | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by participant | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 1 | 2 | 2 | 3 | 2 |
Baseline characteristics
| Characteristic | SIMV 80mg | Total | FDC RSG/SIMV 4/40 mg | FDC RSG/SIMV 4/80 mg | FDC RSG/SIMV 8/40 mg | FDC RSG/SIMV 8/80 mg | RSG 4mg | RSG 8mg | SIMV 40mg |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.5 Years STANDARD_DEVIATION 10.49 | 54.6 Years STANDARD_DEVIATION 9.76 | 55 Years STANDARD_DEVIATION 9.13 | 55.1 Years STANDARD_DEVIATION 10.31 | 56.9 Years STANDARD_DEVIATION 9.07 | 55 Years STANDARD_DEVIATION 8.65 | 53.8 Years STANDARD_DEVIATION 11.37 | 54.6 Years STANDARD_DEVIATION 9.93 | 53.4 Years STANDARD_DEVIATION 9.03 |
| Race/Ethnicity, Customized African American/African Heritage | 2 Participants | 26 Participants | 1 Participants | 0 Participants | 5 Participants | 6 Participants | 7 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 4 Participants | 23 Participants | 1 Participants | 4 Participants | 4 Participants | 1 Participants | 4 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 2 Participants | 5 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 11 Participants | 67 Participants | 10 Participants | 6 Participants | 12 Participants | 6 Participants | 7 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed Race | 6 Participants | 31 Participants | 4 Participants | 7 Participants | 1 Participants | 1 Participants | 2 Participants | 8 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 2 Participants | 8 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White -White/Caucasian/European Heritage | 20 Participants | 203 Participants | 28 Participants | 23 Participants | 20 Participants | 30 Participants | 27 Participants | 27 Participants | 28 Participants |
| Sex: Female, Male Female | 25 Participants | 190 Participants | 23 Participants | 23 Participants | 23 Participants | 22 Participants | 24 Participants | 25 Participants | 25 Participants |
| Sex: Female, Male Male | 22 Participants | 179 Participants | 24 Participants | 21 Participants | 22 Participants | 24 Participants | 24 Participants | 21 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 44 | 0 / 42 | 0 / 45 | 0 / 47 | 0 / 43 | 0 / 44 | 0 / 47 |
| other Total, other adverse events | 4 / 47 | 4 / 44 | 3 / 45 | 10 / 46 | 4 / 48 | 4 / 46 | 5 / 46 | 6 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 44 | 1 / 45 | 1 / 46 | 0 / 48 | 3 / 46 | 0 / 46 | 0 / 47 |
Outcome results
Primary
Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy
Median percent change from Baseline to Week 6 in LDL-c in FDC and RSG monotherapy was reported. Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of an analysis of covariance (ANCOVA) with terms for treatment, gender, current sulfonylurea use (at baseline), country, and Baseline measurement. ANCOVA for LDL-c were performed based on log-transformed data.
Time frame: Baseline (Week 0) and Week 6
Population: Intent-to-Treat Population comprised of all participants who were randomized and had at least one On-Therapy value for an efficacy assessment. The Intent-to-Treat population with last observation carried forward (LOCF) was used for efficacy analyses. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All FDC RSG/SIMV Groups | Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy | -39.9 Percent change in LDL-c |
| All RSG Monotherapy Groups | Median Percent Change From Baseline to Week 6 in LDL-c in FDC and RSG Monotherapy | 5.4 Percent change in LDL-c |
p-value: <0.000195% CI: [-41.219, -32.879]ANCOVA
Secondary
Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG)
Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.
Time frame: Baseline (Week 0) and Week 16
Population: Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All FDC RSG/SIMV Groups | Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | -0.31 Millimol per litre (mmol/L) | Standard Deviation 2.202 |
| All RSG Monotherapy Groups | Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | -1.29 Millimol per litre (mmol/L) | Standard Deviation 3.365 |
| FDC RSG/SIMV 8/40 mg | Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | -2.10 Millimol per litre (mmol/L) | Standard Deviation 2.018 |
| FDC RSG/SIMV 8/80 mg | Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | -1.90 Millimol per litre (mmol/L) | Standard Deviation 2.176 |
| RSG 4 mg | Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | -1.88 Millimol per litre (mmol/L) | Standard Deviation 2.386 |
| RSG 8 mg | Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | -2.23 Millimol per litre (mmol/L) | Standard Deviation 1.621 |
| SIMV 40 mg | Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | 0.43 Millimol per litre (mmol/L) | Standard Deviation 2.526 |
| SIMV 80 mg | Mean Change From Baseline to Week 16 in Fasting Plasma Glucose (FPG) | 0.37 Millimol per litre (mmol/L) | Standard Deviation 2.483 |
Secondary
Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy
Mean change from Baseline to Week 16 in HbA1c in FDC and SIMV monotherapy was reported. Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. The hypothesis of treatment difference was tested at a 0.05 significance level based on two-sided tests. The point estimates and corresponding 95% confidence intervals for treatment differences was calculated. Treatment differences were assessed within the context of ANCOVA with terms for treatment, gender, current sulfonylurea use (at Baseline), country, and Baseline measurement.
Time frame: Baseline (Week 0) and Week 16
Population: Intent-to-Treat with LOCF. Only those participants available at the specified time point were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All FDC RSG/SIMV Groups | Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy | -0.01 mg/dL | Standard Deviation 1.131 |
| All RSG Monotherapy Groups | Mean Change From Baseline to Week 16 in Glycosylated Hemoglobin A1c (HbA1c) in FDC and SIMV Monotherapy | -0.83 mg/dL | Standard Deviation 1.093 |
p-value: <0.000195% CI: [-1.09, -0.55]ANCOVA
Secondary
Mean Change From Baseline to Week 16 in HbA1c
Change from Baseline was computed as (Visit value - Baseline value). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.
Time frame: Baseline (Week 0) and Week 16
Population: Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All FDC RSG/SIMV Groups | Mean Change From Baseline to Week 16 in HbA1c | -0.52 mg/dl | Standard Deviation 0.966 |
| All RSG Monotherapy Groups | Mean Change From Baseline to Week 16 in HbA1c | -0.54 mg/dl | Standard Deviation 1.285 |
| FDC RSG/SIMV 8/40 mg | Mean Change From Baseline to Week 16 in HbA1c | -1.24 mg/dl | Standard Deviation 1.035 |
| FDC RSG/SIMV 8/80 mg | Mean Change From Baseline to Week 16 in HbA1c | -1.06 mg/dl | Standard Deviation 0.901 |
| RSG 4 mg | Mean Change From Baseline to Week 16 in HbA1c | -1.04 mg/dl | Standard Deviation 0.964 |
| RSG 8 mg | Mean Change From Baseline to Week 16 in HbA1c | -1.31 mg/dl | Standard Deviation 1.216 |
| SIMV 40 mg | Mean Change From Baseline to Week 16 in HbA1c | 0.00 mg/dl | Standard Deviation 0.989 |
| SIMV 80 mg | Mean Change From Baseline to Week 16 in HbA1c | -0.02 mg/dl | Standard Deviation 1.258 |
Secondary
Median Percent Change From Baseline to Week 6 in LDL-c
Percent change from Baseline = 100\*(exponent \[change on log scale\]-1). Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available.
Time frame: Baseline (Week 0) and Week 6
Population: Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All FDC RSG/SIMV Groups | Median Percent Change From Baseline to Week 6 in LDL-c | -32.7 Percent change in LDL-c |
| All RSG Monotherapy Groups | Median Percent Change From Baseline to Week 6 in LDL-c | -39.4 Percent change in LDL-c |
| FDC RSG/SIMV 8/40 mg | Median Percent Change From Baseline to Week 6 in LDL-c | -39.0 Percent change in LDL-c |
| FDC RSG/SIMV 8/80 mg | Median Percent Change From Baseline to Week 6 in LDL-c | -44.4 Percent change in LDL-c |
| RSG 4 mg | Median Percent Change From Baseline to Week 6 in LDL-c | 5.6 Percent change in LDL-c |
| RSG 8 mg | Median Percent Change From Baseline to Week 6 in LDL-c | 5.4 Percent change in LDL-c |
| SIMV 40 mg | Median Percent Change From Baseline to Week 6 in LDL-c | -34.0 Percent change in LDL-c |
| SIMV 80 mg | Median Percent Change From Baseline to Week 6 in LDL-c | -44.2 Percent change in LDL-c |
Secondary
Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline
The clinical chemistry parameters analyzed were sodium, potassium, bicarbonate, chloride, calcium, total protein, albumin, creatinine total bilirubin, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, and alkaline phosphatase. The hematology parameters analyzed were hemoglobin, hematocrit, platelet count, total white cell count. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.
Time frame: Up to Week 16
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hemoglobin, Low | 1 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Aspartate Amino Transferase, High | 0 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Gamma Glutamyl Transferase, High | 0 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Alanine Amino Transferase, High | 0 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Creatine Kinase, High | 1 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Carbon Dioxide content / Bicarbonate, Low | 0 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hematocrit, Low | 1 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Calcium, Low | 0 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | White Blood Cells count, Low | 0 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Platelet Count, High | 1 Participants |
| All FDC RSG/SIMV Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Potassium, High | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Gamma Glutamyl Transferase, High | 1 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Carbon Dioxide content / Bicarbonate, Low | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Creatine Kinase, High | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Calcium, Low | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Aspartate Amino Transferase, High | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | White Blood Cells count, Low | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Potassium, High | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hemoglobin, Low | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Platelet Count, High | 1 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hematocrit, Low | 0 Participants |
| All RSG Monotherapy Groups | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Alanine Amino Transferase, High | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hematocrit, Low | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Calcium, Low | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Potassium, High | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Platelet Count, High | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Alanine Amino Transferase, High | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hemoglobin, Low | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Aspartate Amino Transferase, High | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | White Blood Cells count, Low | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Gamma Glutamyl Transferase, High | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Carbon Dioxide content / Bicarbonate, Low | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Creatine Kinase, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Potassium, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | White Blood Cells count, Low | 1 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Alanine Amino Transferase, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Aspartate Amino Transferase, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Creatine Kinase, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Carbon Dioxide content / Bicarbonate, Low | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Calcium, Low | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Platelet Count, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Gamma Glutamyl Transferase, High | 1 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hematocrit, Low | 4 Participants |
| FDC RSG/SIMV 8/80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hemoglobin, Low | 4 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Platelet Count, High | 0 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Creatine Kinase, High | 1 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | White Blood Cells count, Low | 0 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Carbon Dioxide content / Bicarbonate, Low | 0 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Gamma Glutamyl Transferase, High | 1 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Aspartate Amino Transferase, High | 0 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hemoglobin, Low | 0 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hematocrit, Low | 0 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Alanine Amino Transferase, High | 0 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Potassium, High | 0 Participants |
| RSG 4 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Calcium, Low | 1 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | White Blood Cells count, Low | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Calcium, Low | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Creatine Kinase, High | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Gamma Glutamyl Transferase, High | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hematocrit, Low | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Platelet Count, High | 1 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Carbon Dioxide content / Bicarbonate, Low | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Aspartate Amino Transferase, High | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hemoglobin, Low | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Potassium, High | 0 Participants |
| RSG 8 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Alanine Amino Transferase, High | 0 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Gamma Glutamyl Transferase, High | 3 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Calcium, Low | 0 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hemoglobin, Low | 1 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Aspartate Amino Transferase, High | 0 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Carbon Dioxide content / Bicarbonate, Low | 1 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Potassium, High | 0 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Creatine Kinase, High | 0 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hematocrit, Low | 1 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | White Blood Cells count, Low | 0 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Platelet Count, High | 0 Participants |
| SIMV 40 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Alanine Amino Transferase, High | 1 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Creatine Kinase, High | 0 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Potassium, High | 0 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Gamma Glutamyl Transferase, High | 1 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | White Blood Cells count, Low | 0 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Carbon Dioxide content / Bicarbonate, Low | 0 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Aspartate Amino Transferase, High | 1 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Platelet Count, High | 0 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Calcium, Low | 0 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Alanine Amino Transferase, High | 0 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hemoglobin, Low | 3 Participants |
| SIMV 80 mg | Number of of Participants With Laboratory Evaluations of Potential Clinical Concern at Any Time Post-baseline | Hematocrit, Low | 0 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE)
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Up to Week 16
Population: Safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All FDC RSG/SIMV Groups | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAEs | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any AEs | 21 Participants |
| All RSG Monotherapy Groups | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAEs | 0 Participants |
| All RSG Monotherapy Groups | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any AEs | 23 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any AEs | 22 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAEs | 1 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any AEs | 26 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAEs | 1 Participants |
| RSG 4 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any AEs | 19 Participants |
| RSG 4 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAEs | 0 Participants |
| RSG 8 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any AEs | 25 Participants |
| RSG 8 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAEs | 3 Participants |
| SIMV 40 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any AEs | 23 Participants |
| SIMV 40 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAEs | 0 Participants |
| SIMV 80 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any AEs | 21 Participants |
| SIMV 80 mg | Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAEs | 0 Participants |
Secondary
Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16
Number of participants achieving ADA target of FPG\< 126 mg/dL (7.0 mmol/L) or reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 was compared between the all SIM monotherapy group and the all FDC RSG/SIMV groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.
Time frame: Week 16
Population: Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All FDC RSG/SIMV Groups | Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 | 22 Participants |
| All RSG Monotherapy Groups | Number of Participants With FPG< 126 mg/dL (7.0 mmol/L) or Reduction of FPG ≥ 30 mg/dL (1.67 mmol/L) at Week 16 | 96 Participants |
p-value: <0.000195% CI: [2.21, 7]ANCOVA
Secondary
Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16
Number of participants achieving ADA target of HbA1c \< 7.0% or reduction of HbA1c ≥ 0.7% at Week 16 was compared between the FDC groups and the RSG groups groups using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.
Time frame: Up to Week 16
Population: Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All FDC RSG/SIMV Groups | Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16 | 26 Participants |
| All RSG Monotherapy Groups | Number of Participants With HbA1c < 7.0% or Reduction of HbA1c ≥ 0.7% at Week 16 | 108 Participants |
p-value: <0.000195% CI: [2.32, 7.07]ANCOVA
Secondary
Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine
Urine samples were observed for red blood cells and white blood cells. the results were reported as cells per high-power field (cells/HPF). The number of participants with cells in urine were reported.
Time frame: Up to Week 16
Population: Safety population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, Red Blood Cells/HPF | 6 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, White Blood Cells/HPF | 1 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, Red Blood Cells/HPF | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, White Blood Cells/HPF | 2 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, White Blood Cells/HPF | 1 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, White Blood Cells/HPF | 2 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, Red Blood Cells/HPF | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, Red Blood Cells/HPF | 1 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, Red Blood Cells/HPF | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, Red Blood Cells/HPF | 1 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 25-50, White Blood Cells/HPF | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Innumerable, White Blood Cells/HPF | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, White Blood Cells/HPF | 3 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, Red Blood Cells/HPF | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, White Blood Cells/HPF | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, White Blood Cells/HPF | 0 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, Red Blood Cells/HPF | 1 Participants |
| All FDC RSG/SIMV Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, White Blood Cells/HPF | 0 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, Red Blood Cells/HPF | 0 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, Red Blood Cells/HPF | 3 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, White Blood Cells/HPF | 1 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, White Blood Cells/HPF | 1 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, White Blood Cells/HPF | 1 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, Red Blood Cells/HPF | 3 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, Red Blood Cells/HPF | 1 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, Red Blood Cells/HPF | 0 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, White Blood Cells/HPF | 2 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, Red Blood Cells/HPF | 0 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, White Blood Cells/HPF | 1 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, Red Blood Cells/HPF | 1 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 25-50, White Blood Cells/HPF | 1 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, White Blood Cells/HPF | 0 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, White Blood Cells/HPF | 1 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, White Blood Cells/HPF | 0 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Innumerable, White Blood Cells/HPF | 0 Participants |
| All RSG Monotherapy Groups | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, Red Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, White Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, White Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, White Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, Red Blood Cells/HPF | 2 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Innumerable, White Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, Red Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, Red Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, Red Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, White Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, Red Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, White Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, Red Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, White Blood Cells/HPF | 6 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, White Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, Red Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, Red Blood Cells/HPF | 8 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 25-50, White Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, White Blood Cells/HPF | 3 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, White Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, Red Blood Cells/HPF | 3 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 25-50, White Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, Red Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, Red Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Innumerable, White Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, Red Blood Cells/HPF | 8 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, White Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, White Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, White Blood Cells/HPF | 3 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, Red Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, Red Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, White Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, White Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, White Blood Cells/HPF | 1 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, White Blood Cells/HPF | 5 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, Red Blood Cells/HPF | 0 Participants |
| FDC RSG/SIMV 8/80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, Red Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, White Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, Red Blood Cells/HPF | 1 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, Red Blood Cells/HPF | 1 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, Red Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, Red Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, Red Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, Red Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, Red Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, Red Blood Cells/HPF | 9 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, White Blood Cells/HPF | 3 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, White Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, White Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, White Blood Cells/HPF | 1 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 25-50, White Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, White Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, White Blood Cells/HPF | 1 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Innumerable, White Blood Cells/HPF | 0 Participants |
| RSG 4 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, White Blood Cells/HPF | 6 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, Red Blood Cells/HPF | 1 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, White Blood Cells/HPF | 4 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, Red Blood Cells/HPF | 2 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, White Blood Cells/HPF | 1 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, Red Blood Cells/HPF | 8 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 25-50, White Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, Red Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, White Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, Red Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, Red Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, White Blood Cells/HPF | 5 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, White Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, Red Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, White Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, Red Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Innumerable, White Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, White Blood Cells/HPF | 0 Participants |
| RSG 8 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, White Blood Cells/HPF | 1 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, Red Blood Cells/HPF | 2 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, White Blood Cells/HPF | 7 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, White Blood Cells/HPF | 0 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, White Blood Cells/HPF | 0 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, Red Blood Cells/HPF | 0 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Innumerable, White Blood Cells/HPF | 0 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, White Blood Cells/HPF | 1 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, Red Blood Cells/HPF | 0 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, White Blood Cells/HPF | 1 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, Red Blood Cells/HPF | 1 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, Red Blood Cells/HPF | 2 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, White Blood Cells/HPF | 2 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, White Blood Cells/HPF | 0 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, White Blood Cells/HPF | 1 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, Red Blood Cells/HPF | 7 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, Red Blood Cells/HPF | 0 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 25-50, White Blood Cells/HPF | 0 Participants |
| SIMV 40 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, Red Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, Red Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, White Blood Cells/HPF | 6 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, Red Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, White Blood Cells/HPF | 4 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, White Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 50-100, White Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 3-5, Red Blood Cells/HPF | 1 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, White Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 0-1, Red Blood Cells/HPF | 2 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | Innumerable, White Blood Cells/HPF | 3 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, White Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, White Blood Cells/HPF | 1 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 5-10, White Blood Cells/HPF | 3 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 15-25, Red Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | None seen, Red Blood Cells/HPF | 12 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 25-50, White Blood Cells/HPF | 0 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 10-15, Red Blood Cells/HPF | 1 Participants |
| SIMV 80 mg | Number of Participants With Specified Ranges of Red and White Blood Cell Counts Detected in Urine | 1-3, Red Blood Cells/HPF | 1 Participants |
Secondary
Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6
Number of participants achieving American Diabetes Association (ADA) target of LDL\<100 mg/dL (2.59 mmol/L) at Week 6 was compared between the FDC groups and the all SIMV group using logistic regression with terms for treatment, Baseline value, gender and current sulfonylurea use (at Baseline) in the model.
Time frame: Week 6
Population: Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All FDC RSG/SIMV Groups | Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6 | 20 Participants |
| All RSG Monotherapy Groups | Number of Participant With LDL<100 mg/dL (2.59 mmol/L) at Week 6 | 148 Participants |
p-value: <0.000195% CI: [16.52, 79.85]ANCOVA
Secondary
On-Therapy Change From Baseline in Body Weight
Baseline assessments were recorded at Visit 3 (Week 0). For a missing Baseline value, the Baseline value were replaced by the last pre-treatment measurement, if available. Change from Baseline was computed as: Visit value - Baseline Value.
Time frame: Up to Week 16
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All FDC RSG/SIMV Groups | On-Therapy Change From Baseline in Body Weight | Week 6 | 0.9 Kilogram | Standard Deviation 3.45 |
| All FDC RSG/SIMV Groups | On-Therapy Change From Baseline in Body Weight | Week 16 | 0.4 Kilogram | Standard Deviation 4.39 |
| All RSG Monotherapy Groups | On-Therapy Change From Baseline in Body Weight | Week 6 | -0.3 Kilogram | Standard Deviation 2.83 |
| All RSG Monotherapy Groups | On-Therapy Change From Baseline in Body Weight | Week 16 | 0.8 Kilogram | Standard Deviation 2.75 |
| FDC RSG/SIMV 8/40 mg | On-Therapy Change From Baseline in Body Weight | Week 6 | 0.0 Kilogram | Standard Deviation 1.8 |
| FDC RSG/SIMV 8/40 mg | On-Therapy Change From Baseline in Body Weight | Week 16 | 1.7 Kilogram | Standard Deviation 2.51 |
| FDC RSG/SIMV 8/80 mg | On-Therapy Change From Baseline in Body Weight | Week 6 | 0.4 Kilogram | Standard Deviation 1.85 |
| FDC RSG/SIMV 8/80 mg | On-Therapy Change From Baseline in Body Weight | Week 16 | 1.1 Kilogram | Standard Deviation 3.98 |
| RSG 4 mg | On-Therapy Change From Baseline in Body Weight | Week 6 | 0.5 Kilogram | Standard Deviation 2.07 |
| RSG 4 mg | On-Therapy Change From Baseline in Body Weight | Week 16 | 1.4 Kilogram | Standard Deviation 4.41 |
| RSG 8 mg | On-Therapy Change From Baseline in Body Weight | Week 6 | 0.8 Kilogram | Standard Deviation 2.66 |
| RSG 8 mg | On-Therapy Change From Baseline in Body Weight | Week 16 | 2.2 Kilogram | Standard Deviation 3.94 |
| SIMV 40 mg | On-Therapy Change From Baseline in Body Weight | Week 16 | -0.5 Kilogram | Standard Deviation 3.26 |
| SIMV 40 mg | On-Therapy Change From Baseline in Body Weight | Week 6 | -0.5 Kilogram | Standard Deviation 1.84 |
| SIMV 80 mg | On-Therapy Change From Baseline in Body Weight | Week 6 | -0.2 Kilogram | Standard Deviation 1.93 |
| SIMV 80 mg | On-Therapy Change From Baseline in Body Weight | Week 16 | -1.5 Kilogram | Standard Deviation 3.57 |
Secondary
On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate
The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (\<85 and \>160 millimeter of mercury \[mmHg\]), diastolic blood pressure (\<45 and \>100 mmHg) and heart rate (\<40 and \>110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.
Time frame: Up to Week 16
Population: Safety Population comprised of all participants who were randomized and received at least one dose of study medication. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All FDC RSG/SIMV Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, High | 1 Participants |
| All FDC RSG/SIMV Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Heart Rate, Low | 1 Participants |
| All FDC RSG/SIMV Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, Low | 1 Participants |
| All FDC RSG/SIMV Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, High | 0 Participants |
| All FDC RSG/SIMV Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, Low | 0 Participants |
| All RSG Monotherapy Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, Low | 0 Participants |
| All RSG Monotherapy Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, Low | 0 Participants |
| All RSG Monotherapy Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Heart Rate, Low | 1 Participants |
| All RSG Monotherapy Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, High | 0 Participants |
| All RSG Monotherapy Groups | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, High | 1 Participants |
| FDC RSG/SIMV 8/40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, Low | 2 Participants |
| FDC RSG/SIMV 8/40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Heart Rate, Low | 0 Participants |
| FDC RSG/SIMV 8/40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, High | 1 Participants |
| FDC RSG/SIMV 8/40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, Low | 0 Participants |
| FDC RSG/SIMV 8/40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Heart Rate, Low | 1 Participants |
| FDC RSG/SIMV 8/80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, High | 0 Participants |
| FDC RSG/SIMV 8/80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, Low | 3 Participants |
| FDC RSG/SIMV 8/80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, Low | 0 Participants |
| RSG 4 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, High | 0 Participants |
| RSG 4 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, High | 0 Participants |
| RSG 4 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, Low | 2 Participants |
| RSG 4 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, Low | 0 Participants |
| RSG 4 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Heart Rate, Low | 0 Participants |
| RSG 8 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, High | 0 Participants |
| RSG 8 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, Low | 0 Participants |
| RSG 8 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, Low | 3 Participants |
| RSG 8 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, High | 2 Participants |
| RSG 8 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Heart Rate, Low | 0 Participants |
| SIMV 40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Heart Rate, Low | 0 Participants |
| SIMV 40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, High | 2 Participants |
| SIMV 40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, High | 1 Participants |
| SIMV 40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, Low | 0 Participants |
| SIMV 40 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, Low | 0 Participants |
| SIMV 80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, Low | 1 Participants |
| SIMV 80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, Low | 1 Participants |
| SIMV 80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Diastolic BP, High | 0 Participants |
| SIMV 80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Systolic BP, High | 0 Participants |
| SIMV 80 mg | On-Therapy Vital Signs of Potential Clinical Concern Including Systolic, Diastolic Blood Pressure and Heart Rate | Heart Rate, Low | 2 Participants |