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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK523338 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0) and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tucson | Arizona | 85745 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| AVS101946 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed Dose Combination (FDC) 4/40 Milligram (mg) | Participants received FDC of rosiglitazone (RSG) 4.0 mg and simvastatin (SIMV) 40 mg (FDC 4/40) and matching placebo once a day for 16 weeks. In case of the participants who had Low Density Lipoprotein-cholesterol (LDL-c) > 130 milligram per deciliter (mg/dL) at Visit 4a (Week 6) the treatment doses were up titrated to FDC RSG/SIMV 4/40 mg and SIMV 40 mg from Week 6 till Week 16. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline (Week 0) and Week 16 |
| 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. | Baseline (Week 0) and Week 6 |
| 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. | Baseline (Week 0) and Week 16 |
| 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. | Baseline (Week 0) and Week 16 |
| 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. | Week 6 |
| 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. | Up to Week 16 |
| 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. | Week 16 |
| 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. | Up to Week 16 |
| 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. | Up to Week 16 |
| 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. | Up to Week 16 |
| 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. | Up to Week 16 |
| 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. | Up to Week 16 |
| Fresno |
| California |
| 93720 |
| United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Waterbury | Connecticut | 06708 | United States |
| GSK Investigational Site | Miami | Florida | 33156 | United States |
| GSK Investigational Site | Saint Cloud | Florida | 34769 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | Chicago | Illinois | 60607 | United States |
| GSK Investigational Site | Melrose Park | Illinois | 60160 | United States |
| GSK Investigational Site | Springfield | Illinois | 62704 | United States |
| GSK Investigational Site | Avon | Indiana | 46123 | United States |
| GSK Investigational Site | Elkhart | Indiana | 46515 | United States |
| GSK Investigational Site | Sunset | Louisiana | 70584 | United States |
| GSK Investigational Site | Waltham | Massachusetts | 02453 | United States |
| GSK Investigational Site | City of Saint Peters | Missouri | 63376 | United States |
| GSK Investigational Site | Billings | Montana | 59102 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89103 | United States |
| GSK Investigational Site | Jamaica | New York | 11432 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | Columbus | Ohio | 43212 | United States |
| GSK Investigational Site | Bend | Oregon | 97701 | United States |
| GSK Investigational Site | Portland | Oregon | 97216 | United States |
| GSK Investigational Site | Portland | Oregon | 97219 | United States |
| GSK Investigational Site | Portland | Oregon | 97239 | United States |
| GSK Investigational Site | Tualatin | Oregon | 97062 | United States |
| GSK Investigational Site | Beaver | Pennsylvania | 15009 | United States |
| GSK Investigational Site | Fleetwood | Pennsylvania | 19522 | United States |
| GSK Investigational Site | Jefferson Hills | Pennsylvania | 15025 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19152 | United States |
| GSK Investigational Site | Clinton | South Carolina | 29325 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Bryan | Texas | 77802 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Georgetown | Texas | 78626 | United States |
| GSK Investigational Site | Midland | Texas | 79705 | United States |
| GSK Investigational Site | Plano | Texas | 75093 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84143 | United States |
| GSK Investigational Site | Burke | Virginia | 22015 | United States |
| GSK Investigational Site | Manassas | Virginia | 20110 | United States |
| GSK Investigational Site | Bellevue | Washington | 98004 | United States |
| GSK Investigational Site | Spokane | Washington | 99208 | United States |
| GSK Investigational Site | Vancouver | Washington | 98664 | United States |
| GSK Investigational Site | Wollongong | New South Wales | 2500 | Australia |
| GSK Investigational Site | Kippa-Ring | Queensland | 4021 | Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Keswick | South Australia | 5035 | Australia |
| GSK Investigational Site | Port Lincoln | South Australia | 5606 | Australia |
| GSK Investigational Site | Box Hill | Victoria | 3128 | Australia |
| GSK Investigational Site | Heidelberg West | Victoria | 3081 | Australia |
| GSK Investigational Site | Ringwood East | Victoria | 3135 | Australia |
| GSK Investigational Site | Edmonton | Alberta | T5J 3N4 | Canada |
| GSK Investigational Site | Edmonton | Alberta | T5N 3Y6 | Canada |
| GSK Investigational Site | Coquitlam | British Columbia | V3K 3V9 | Canada |
| GSK Investigational Site | Moncton | New Brunswick | E1G1A7 | Canada |
| GSK Investigational Site | Mount Pearl | Newfoundland and Labrador | A1N 1W7 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 5R3 | Canada |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 3T1 | Canada |
| GSK Investigational Site | Greater Sudbury | Ontario | P3A 1Y8 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8M 1K7 | Canada |
| GSK Investigational Site | North Bay | Ontario | P1B 2H3 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3H 5S4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M8V 3X8 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Woodstock | Ontario | N4S 4G3 | Canada |
| GSK Investigational Site | Bonaventure | Quebec | G0C 1E0 | Canada |
| GSK Investigational Site | Gatineau | Quebec | J8Y 6S8 | Canada |
| GSK Investigational Site | Granby | Quebec | J2G 8Z9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2K 4L5 | Canada |
| GSK Investigational Site | Plessisville | Quebec | G6L 3J1 | Canada |
| GSK Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Saint-Marc-des-Carrieres | Quebec | G0A 4B0 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 1V6 | Canada |
| GSK Investigational Site | Sainte-Foy | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1H 4J6 | Canada |
| GSK Investigational Site | Saskatoon | Saskatchewan | S7K 7H9 | Canada |
| GSK Investigational Site | Guadalajara | Jalisco | 44340 | Mexico |
| GSK Investigational Site | Cuernavaca | Morelos | 62420 | Mexico |
| GSK Investigational Site | Monterrey | Nuevo León | 64570 | Mexico |
| GSK Investigational Site | México | 14080 | Mexico |
| GSK Investigational Site | Manila | 1008 | Philippines |
| GSK Investigational Site | Quezon City | 1100 | Philippines |
| GSK Investigational Site | Quezon City | 1113 | Philippines |
| GSK Investigational Site | Carolina | 00983 | Puerto Rico |
For additional information about this study please refer to the GSK Clinical Study Register |
| AVS101946 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVS101946 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVS101946 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVS101946 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVS101946 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| AVS101946 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | FDC 4/80 mg | Participants received FDC RSG/SIMV 4/80 mg and SIMV 40 mg matching placebo once a day for 16 weeks. |
| FG002 | FDC 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 from Week 6 till Week 16. |
| FG003 | FDC 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | SIMV 80mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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|
Safety Population comprised of all participants who were randomized and received at least one dose of study medication. No race information available for one participant in arm SIMV 40mg.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | SIMV 80mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Full Range | Percent change in LDL-c | Baseline (Week 0) and Week 6 |
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| 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. | Intent-to-Treat with LOCF. Only those participants available at the specified time point were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0) and Week 16 |
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| 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. | Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed. | Posted | Median | Full Range | Percent change in LDL-c | Baseline (Week 0) and Week 6 |
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| 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. | Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | mg/dl | Baseline (Week 0) and Week 16 |
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| 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. | Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimol per litre (mmol/L) | Baseline (Week 0) and Week 16 |
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| 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. | Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Week 6 |
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| 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. | Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to Week 16 |
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| 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. | Intent-to-Treat with LOCF. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Week 16 |
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| 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. | 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. | Posted | Count of Participants | Participants | Up to Week 16 |
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| 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. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Kilogram | Up to Week 16 |
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| 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. | Safety population | Posted | Count of Participants | Participants | Up to Week 16 |
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| 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. | Safety population. | Posted | Count of Participants | Participants | Up to Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety population | Posted | Count of Participants | Participants | Up to Week 16 |
|
SAEs and nSAEs were recorded up to Week 16
Safety population was used to record AEs
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 45 | 0 | 47 | 4 | 47 |
| EG001 | 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. | 0 | 44 | 0 | 44 | 4 | 44 |
| EG002 | 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. | 0 | 42 | 1 | 45 | 3 | 45 |
| EG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. | 0 | 45 | 1 | 46 | 10 | 46 |
| EG004 | RSG 4 mg | 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. | 0 | 47 | 0 | 48 | 4 | 48 |
| EG005 | RSG 8 mg | 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. | 0 | 43 | 3 | 46 | 4 | 46 |
| EG006 | SIMV 40 mg | 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. | 0 | 44 | 0 | 46 | 5 | 46 |
| EG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. | 0 | 47 | 0 | 47 | 6 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Male |
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| American Indian or Alaska Native |
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| Asian - Central/South Asian Heritage |
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| Asian - East Asian Heritage |
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| Asian - South East Asian Heritage |
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| Native Hawaiian or other Pacific Islander |
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| White - Arabic/North African Heritage |
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| White -White/Caucasian/European Heritage |
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| Mixed Race |
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| Missing |
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| OG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| OG004 | RSG 4 mg | 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. |
| OG005 | RSG 8 mg | 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. |
| OG006 | SIMV 40 mg | 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. |
| OG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
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| OG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| OG004 | RSG 4 mg | 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. |
| OG005 | RSG 8 mg | 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. |
| OG006 | SIMV 40 mg | 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. |
| OG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
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| OG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| OG004 | RSG 4 mg | 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. |
| OG005 | RSG 8 mg | 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. |
| OG006 | SIMV 40 mg | 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. |
| OG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
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| 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. |
| OG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| OG004 | RSG 4 mg | 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. |
| OG005 | RSG 8 mg | 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. |
| OG006 | SIMV 40 mg | 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. |
| OG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
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|
| OG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| OG004 | RSG 4 mg | 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. |
| OG005 | RSG 8 mg | 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. |
| OG006 | SIMV 40 mg | 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. |
| OG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
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|
| OG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| OG004 | RSG 4 mg | 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. |
| OG005 | RSG 8 mg | 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. |
| OG006 | SIMV 40 mg | 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. |
| OG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
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| OG002 | 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. |
| OG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| OG004 | RSG 4 mg | 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. |
| OG005 | RSG 8 mg | 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. |
| OG006 | SIMV 40 mg | 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. |
| OG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
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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. |
| OG003 | FDC RSG/SIMV 8/80 mg | Participants received FDC RSG/SIMV 8/80 mg and matching placebo once a day for 16 weeks. |
| OG004 | RSG 4 mg | 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. |
| OG005 | RSG 8 mg | 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. |
| OG006 | SIMV 40 mg | 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. |
| OG007 | SIMV 80 mg | Participants received SIMV/SIMV 40/40 mg once a day for 16 weeks. |
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