| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo, HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study., Baseline, Week 12 | Secondary: Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8, HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study. n represented the available number of participants for analysis at post-baseline days., Baseline, Weeks 2, 4, 8|Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12, Fasting plasma glucose response changed from baseline at Weeks 2,4,8 and 12. Baseline was defined as the average of the measurements obtained during Day 14 visit window and Day 1 pre-dose measurement. n represented the available number of participants for analysis at post-baseline days., Baseline, Weeks 2,4,8 and 12|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12., HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time., Week 12|Number of Participants With Laboratory Test Abnormalities, The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests., Baseline up to 98 days|Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria, ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): \>=140 milliseconds (msec); \>=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): \>=300 msec; \>=25 percent (%) increase when baseline \>200 msec; or increase \>=50% when baseline less than or equal to (\<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value \>=450 - \<480 msec, \>=480-\<500 msec, \>=500 msec; increase from baseline \>=30 - \<60, \>=60 msec., Baseline up to Day 98|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria, Vital signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (\<) 90 mm Hg; diastolic BP (DBP) \>=20 mm Hg change from baseline, diastolic \<50 mm Hg; 2), pulse rate \<40 or greater than (\>) 120 beats per minute (bpm)., Baseline up to Day 98|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs)., An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug; the event need not necessarily have a causal relationship with the treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reasons: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. Any events occurring following start of treatment (defined as blinded therapy, including single blind placebo administration on Day 14) or increasing in severity were counted as treatment emergent AE., Baseline up to Day 119|Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12, Fasting low density lipoprotein-cholesterol (LDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days., Baseline, Weeks 2, 4, 8 and 12|Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12, Triglycerides percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days. Triglycerides MMRM was not appropriate as the data were very skewed and not normally distributed, therefore per SAP non-parametric analysis were reported, presenting medians and CIs for medians, instead. If the data had many outliers even after the log transformation the following non parametric analysis was presented instead of the MMRM. An outlier was defined as any data point falling outside of 3.5 x standard deviations the median., Baseline, Weeks 2, 4, 8 and 12|Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12, Total cholesterol percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days., Baseline, Weeks 2, 4, 8 and 12|Percent Changes From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Weeks 2, 4, 8 and 12, High density lipoprotein-cholesterol (HDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days., Baseline, Weeks 2, 4, 8 and 12|Percent Changes From Baseline for Non-High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12, Non-HDL-C percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days., Baseline, Weeks 2, 4, 8 and 12|Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12., The body weight change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days., Baseline, Weeks 2, 4, 8 and 12
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| Locations: |
Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|National Research Institute, Los Angeles, California, 90057, United States|NRC Research Institute, Orange, California, 92868, United States|Sierra Clinical Research, Roseville, California, 95661, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Empire Clinical Research, Upland, California, 91786, United States|Diablo Clinical Research, Inc, Walnut Creek, California, 94598, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|Avail Clinical Research, LLC, DeLand, Florida, 32720, United States|Suncoast Research Group, Llc, Miami, Florida, 33135, United States|QPS-MRA, LLC (Miami Research Associates), South Miami, Florida, 33143, United States|Palm Beach Research Center, West Palm Beach, Florida, 33409, United States|WR-Mount Vernon Clinical Research, LLC, Sandy Springs, Georgia, 30328, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Midwest Institute for Clinical Research, Indianapolis, Indiana, 46260, United States|Crescent City Clinical Research Center, LLC, Metairie, Louisiana, 70006, United States|St. Louis Clinical Trials, LC, Saint Louis, Missouri, 63141, United States|ALAS Science Clinical Research, Las Vegas, Nevada, 89120, United States|Comprehensive Clinical Research, Berlin, New Jersey, 08009, United States|Clinilabs Inc., Eatontown, New Jersey, 07724, United States|Pharmaceutical Research Associates, Inc., Marlton, New Jersey, 08053, United States|TLB Research, Trenton, New Jersey, 08611, United States|Randolph Medical Associates, Asheboro, North Carolina, 27203, United States|High Point Clinical Trials Center, LLC, High Point, North Carolina, 27265, United States|Lillestol Research, LLC, Fargo, North Dakota, 58103, United States|Aventiv Research, Columbus, Ohio, 43213, United States|Juno Research, LLC, Houston, Texas, 77074, United States|Texas Center for Drug Development, Inc., Houston, Texas, 77081, United States|Juno Research, LLC, Katy, Texas, 77450, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|Northeast Clinical Research of San Antonio, LLC, Schertz, Texas, 78154, United States|National Clinical Research - Richmond, Inc., Richmond, Virginia, 23294, United States|Aggarwal and Associates Limited, Brampton, Ontario, L6T 0G1, Canada|LMC Clinical Research Inc. (Thornhill), Thornhill, Ontario, L4J 8L7, Canada|LMC Clinical Research Inc. (Bayview), Toronto, Ontario, M4G 3E8, Canada|Manna Research, Toronto, Ontario, M9W 4L6, Canada|Manna Research Inc., Lévis, Quebec, G6W 0M6, Canada|Omnispec Clinical Research, Inc., Mirabel, Quebec, J7J 2K8, Canada
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