| Outcome Measures: |
Primary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16, HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%., Baseline, Week 16 | Secondary: Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels, HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%., Baseline, Week 16|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2, HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%., Baseline, Week 2|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4, HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%., Baseline, Week 4|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6, HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%., Baseline, Week 6|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8, HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%., Baseline, Week 8|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12, HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%., Baseline, Week 12|Change From Baseline in Fasting Plasma Glucose at Week 2, The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 milligram per deciliter (mg/dL) to 99 mg/dL., Baseline, Week 2|Change From Baseline in Fasting Plasma Glucose at Week 4, The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL., Baseline, Week 4|Change From Baseline in Fasting Plasma Glucose at Week 6, The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL., Baseline, Week 6|Change From Baseline in Fasting Plasma Glucose at Week 8, The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL., Baseline, Week 8|Change From Baseline in Fasting Plasma Glucose at Week 12, The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL., Baseline, Week 12|Change From Baseline in Fasting Plasma Glucose at Week 16, The fasting plasma glucose test measures the levels of glucose (sugar) in the blood, with a normal range of 70 mg/dL to 99 mg/dL., Baseline, Week 16|Change From Baseline in Body Weight at Week 2, Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 2|Change From Baseline in Body Weight at Week 4, Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 4|Change From Baseline in Body Weight at Week 6, Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 6|Change From Baseline in Body Weight at Week 8, Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 8|Change From Baseline in Body Weight at Week 12, Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 12|Change From Baseline in Body Weight at Week 16, Weight was recorded using a calibrated scale (with the same scale used if possible for the duration of the study) reporting weight in kilograms (kg), and accuracy to the nearest 0.1 kg., Baseline, Week 16|Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs]), An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent., Baseline up to Week 21|Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality, Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, PT/INR, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin); lipid panel (low density lipoprotein cholesterol, high density lipoprotein cholesterol)., Baseline Through Week 21|Number of Participants With Treatment Emergent Vital Signs Abnormalities, Vital signs abnormality criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>= 20 mmHg., Baseline through Week 21|Number of Participants With Treatment Emergent ECG Abnormalities, ECG categorical abnormality criteria: 1. PR interval (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): a) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \>=140 msec, b) \>=50% increase from baseline. 3. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and \<=480 msec, b) \>480 msec and \<=500 msec, c) \>500 msec, d) \>30 msec and \<=60 msec increase from baseline, e) \>60 msec increase from baseline., Baseline Through Week 21
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| Locations: |
Holy Trinity Medical Clinic, Harbor City, California, 90710, United States|Innovative Clinical Research, Inc., Harbor City, California, 90710, United States|Long Beach Clinical Trials Services, Inc., Long Beach, California, 90806, United States|National Research Institute, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Empire Clinical Research, Pomona, California, 91767, United States|Rancho Cucamonga Clinical Research, Rancho Cucamonga, California, 91730, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|University Clinical Investigators, Incorporated, Tustin, California, 92780, United States|San Fernando Valley Health Institute, LLC, Van Nuys, California, 91405, United States|Diablo Clinical Research Incorporated, Walnut Creek, California, 94598, United States|Accel Research Sites - DeLand Clinical Research Unit, DeLand, Florida, 32720, United States|East Coast Institute for Research, LLC, Jacksonville, Florida, 32204, United States|East Coast Institute for Research, LLC, Jacksonville, Florida, 32216, United States|NewPhase Clinical Trials, Corp., Miami Beach, Florida, 33140, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Sunshine Research Center, Inc, Opa-locka, Florida, 33054, United States|Andres Patron D.O. P.A., Pembroke Pines, Florida, 33026, United States|Ellipsis Group, Alpharetta, Georgia, 30022, United States|East Coast Institute for Research, LLC, Macon, Georgia, 31210, United States|Cedar Crosse Research Center, Chicago, Illinois, 60607, United States|Buynak Clinical Research, Valparaiso, Indiana, 46383, United States|Viable Research Management LLC, Henderson, Nevada, 89014, United States|Premier Research, Trenton, New Jersey, 08611, United States|PharmQuest, Greensboro, North Carolina, 27408, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Velocity Clinical Research, Cincinnati, Ohio, 45242, United States|Conrad Clinical Research, Edmond, Oklahoma, 73013, United States|Family Medical Associates, Levittown, Pennsylvania, 19056, United States|Preferred Primary Care Physicians, Inc., Pittsburgh, Pennsylvania, 15236, United States|Spartanburg Medical Research, Spartanburg, South Carolina, 29303, United States|Palmetto Clinical Research, Summerville, South Carolina, 29485, United States|Palmetto Primary Care Physicians (physicals only), Summerville, South Carolina, 29485, United States|Dallas Diabetes Research Center, Dallas, Texas, 75230, United States|Endocrine Associates, Houston, Texas, 77004, United States|PrimeCare Medical Group, Houston, Texas, 77024, United States|Juno Research, LLC, Houston, Texas, 77074, United States|Northeast Clinical Research of San Antonio, Live Oak, Texas, 78233, United States|Sun Research Institute, San Antonio, Texas, 78215, United States|DM Clinical Research, Tomball, Texas, 77375, United States|Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|Rainier Clinical Research Center, Inc., Renton, Washington, 98057, United States|MHAT Dobrich AD, Dobrich, 9300, Bulgaria|Medical Center ASKLEPII OOD, Dupnitsa, 2600, Bulgaria|UMHAT Pulmed, Plovdiv, 4002, Bulgaria|Fourth MHAT - Sofia EAD, Sofia, 1606, Bulgaria|MHAT "Doverie" AD, Sofia, 1632, Bulgaria|MC "New rehabilitation center" EOOD, Stara Zagora, 6000, Bulgaria|GA Research Associates Ltd., Moncton, New Brunswick, E1G 1A7, Canada|Aggarwal and Associates Limited, Brampton, Ontario, L6T 0G1, Canada|Manna Research (Toronto), Toronto, Ontario, M9W4L6, Canada|Manna Research (Quebec), Levis, Quebec, G6W 0M5, Canada|Manna Research (Mirabel), Mirabel, Quebec, J7J 2K8, Canada|Diex Recherche Sherbrooke Inc., Sherbrooke, Quebec, J1L 0H8, Canada|Diex Recherche Victoriaville Inc., Victoriaville, Quebec, G6P 6P6, Canada|Diex Recherche Quebec Inc., Quebec, G1N 4V3, Canada|Centre de Recherche Saint-Louis, Quebec, G1W 4R4, Canada|Alpha Recherche Clinique, Quebec, G3K2P8, Canada|Belinus Orvosi es Szamitastechnikai Bt, Debrecen, 4025, Hungary|Debreceni Egyetem Klinikai Kozpont, Debrecen, 4032, Hungary|CRU Hungary Kft., Miskolc, 3529, Hungary|Borbanya Praxis Egeszsegugyi KFT, Nyiregyhaza, H-4405, Hungary|Clinfan Kft., Szekszard, H-7100, Hungary|Yonsei University-Wonju Severance Christian Hospital, Wonju-si, Gangwon-do, 26426, Korea, Republic of|Hanyang University Guri Hospital, Guri-si, Gyeonggi-do, 11923, Korea, Republic of|Ajou University Hospital, Suwon-si, Gyeonggi-do, 16499, Korea, Republic of|Samsung Medical Center, Gangnam-Gu, Seoul, 06351, Korea, Republic of|Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik, Bialystok, 15-351, Poland|Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne DIAB-ENDO-MET Sp. z o. o., Krakow, 31-261, Poland|Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer, Lodz, 94-060, Poland|MEDICOME Sp. z o.o., Oswiecim, 32-600, Poland|KO-MED CENTRA KLINICZNE Sp. z o.o. Ośrodek Badań Klinicznych w Puławach, Puławy, 24-100, Poland|Centralny Szpital Kliniczny MSWiA, Warszawa, 02-507, Poland|Metabol KLINIK s.r.o., Bratislava, 811 08, Slovakia|Medispektrum, s.r.o, Bratislava, 851 01, Slovakia|HUMAN-CARE, s.r.o., Kosice, 040 01, Slovakia|SchronerMED s.r.o., Moldava nad Bodvou, 04501, Slovakia|Funkystuff, s.r.o., Nove Zamky, 940 01, Slovakia|DIAB s.r.o., Roznava, 048 01, Slovakia|MUDr. Jana Rociakova, s.r.o., Zilina, 010 01, Slovakia|Far Eastern Memorial Hospital, New Taipei City, 220, Taiwan|Taichung Veterans General Hospital, Taichung, 40705, Taiwan|National Cheng Kung University Hospital, Tainan, 704, Taiwan
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