| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12, HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (\<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported., Baseline (Day 1), Week 12 | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8, HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as \<6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported., Baseline(Day 1), Week 2, 4, 8|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14, Baseline (Day 1), Week 1, 2, 4, 8, 12, 14|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12, HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as \<6.5 percent by the study-specific central laboratory used and data are presented in categories of \<6.5 percent and \<7 percent., Week 12|Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data, Criteria for increase from baseline data: PR interval (percent change of greater than or equal to \[\>=\] 25/50% \[if baseline\>200 then percent change of \>25% counts; if baseline \<=200 then percent change of \>50% counts\]; QRS complex (percent change of \>=50%); QT Fridericia's correction (QTcF) interval (change of \>=30 to \<60 millisecond \[msec\], and change of \>=60 msec)., Baseline (Day 1) up to Week 14|Number of Participants With Increase/Decrease From Baseline Vital Signs Data, Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of \>=30 millimeter of mercury (mmHg); sitting diastolic BP of \>=20 mmHg and pulse rate was based on investigator's discretion., Baseline (Day 1) up to Week 14|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs), An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events., Baseline (Day 1) up to 14 days after last dose (up to 101 days)|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode, A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =\< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =\<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =\<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =\<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers., Baseline (Day 1) up to Week 14|Number of Hypoglycemic Events (HAE) Episodes Per Participant, A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported, Baseline (Day 1) up to Week 14|Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14, Baseline (Day 1), Week 2, 4, 8 , 12 , 14|Number of Participants With Abnormal Laboratory Values, Hemoglobin,hematocrit,red blood cells(RBC) count:less than \[\<\]0.8\*lower limit of normal\[LLN\],platelets:\<0.5\*LLN/greater than \[\>\]1.75\*upper limit of normal \[ULN\],white blood cells(WBC):\<0.6\*LLN or \>1.5\*ULN,lymphocytes,total neutrophils:\<0.8\*LLN or \>1.2\*ULN, basophils,eosinophil,monocytes:\>1.2\*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:\>0.3\*ULN,total protein,albumin:\<0.8\*LLN or \>1.2\*ULN;total bilirubin,direct bilirubin,indirect bilirubin:\>1.5\*ULN;triglycerides,cholesterol:\>1.3\*ULN, HDL:\<0.8\*LLN, LDL:\>1.2\*ULN,blood urea nitrogen,creatinine:\>1.3\*ULN,uric acid:\>1.2\*ULN;sodium: \<0.95\*LLN or \>1.05\*ULN,potassium,chloride,calcium,bicarbonate:\<0.9\*LLN or \>1.1\*ULN;creatine kinase:\>2.0\*ULN;glucose:\<0.6\*LLN or \>1.5\*ULN,urine WBC and RBC:\>= 20/High Power Field \[HPF\]),urine epithelial cells (\>=1 HPF),urine bacteria \>20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (\>=1);urine(protein,nitrite,mucus,leukocyte \>=1 in urine dipstick test)., Baseline (Day 1) up to Week 14
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| Locations: |
Anaheim Clinical Trials, Anaheim, California, 92801, United States|National Research Institute, Los Angeles, California, 90057, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|The Family Doctors of Belleview, Belleview, Florida, 34420, United States|Swiss Medical Research, Miami, Florida, 33135, United States|Renstar Medical Research, Ocala, Florida, 34471, United States|Rockdale Medical Research Associates, Conyers, Georgia, 30094, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Central Kentucky Research Associates, Inc., Mount Sterling, Kentucky, 40353, United States|Mount Sterling Clinic, Mount Sterling, Kentucky, 40353, United States|The Office of Dr. Matthew S. Barton, MD, Las Vegas, Nevada, 89144, United States|TKL Research, Inc., Paramus, New Jersey, 07652, United States|Rochester Clinical Research, Inc., Rochester, New York, 14609, United States|Lillestol Research, LLC, Fargo, North Dakota, 58103, United States|PriMed Clinical Research, Kettering, Ohio, 45429, United States|PriMed Physicians, Kettering, Ohio, 45429, United States|Lynn Health Science Institute, Oklahoma City, Oklahoma, 73112, United States|Medical Research South, LLC, Charleston, South Carolina, 29407, United States|Newton Family Medicine, Charleston, South Carolina, 29407, United States|Austin Center for Clinical Research, Austin, Texas, 78756, United States|Texas Center for Drug Development, Inc., Houston, Texas, 77081, United States|Plano Primary Care Clinic, Plano, Texas, 75024, United States|Pioneer Research Solutions, Inc., Sugar Land, Texas, 77479, United States|Martin Diagnostic Clinic, Tomball, Texas, 77375, United States|DRC Kft., Balatonfured, 8230, Hungary|Dr. Rethy Pal Korhaz-Rendelointezet, Bekescsaba, 5600, Hungary|Qualiclinic Kft., Budapest, 1036, Hungary|Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Debrecen, 4032, Hungary|Kenezy Korhaz Rendelointezet Egeszsegugyi Nonprofit Kft., Debrecen, 4043, Hungary|Petz Aladar Megyei Oktato Korhaz, Gyor, 9023, Hungary|Polgar es Tersege Egeszsegugyi Kozpont Nonprofit Zrt., Polgar, 4090, Hungary|Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged, 6720, Hungary|Zala Megyei Korhaz, Zalaegerszeg, 8900, Hungary|Bhatia Hospital, Mumbai, Maharashtra, 400 007, India|Seth G S Medical College & KEM Hospital, Dept of Endocrinology,, Mumbai, Maharashtra, 400 012, India|Jehangir Clinical Development Centre Pvt. Ltd., Pune, Maharashtra, 411001, India|S.R. Kalla Memorial Gastro and General Hospital, Jaipur, Rajasthan, 302001, India|Vicente Sotto Memorial Medical Center, Cebu City, 6000, Philippines|Institute for Studies on Diabetes Foundation Inc., Marikina City, 1810, Philippines|The Medical City, Pasig City, 1605, Philippines|Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Cluj-Napoca, Jud. Cluj, 400006, Romania|Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu, Bucuresti, 011234, Romania|Institutul National de Diabet, Nutritie si Boli Metabolice Prof. Dr. N. Paulescu, Bucuresti, 020475, Romania|Metabolicke centrum MUDr. Katariny Raslovej, s.r.o., Bratislava, 831 01, Slovakia|Medispektrum Plus, s.r.o., Bratislava, 851 01, Slovakia|IN-DIA, s.r.o., Lucenec, 984 01, Slovakia|MUDr. Zuzana Ochodnicka, Interna diabetologicka ambulancia, s.r.o., Nitra, 949 01, Slovakia|NOEMIS, s.r.o., Nove Mesto nad Vahom, 915 01, Slovakia|DIABETOL, s.r.o., Presov, 080 01, Slovakia|Areteus, s.r.o., Trebisov, 075 01, Slovakia|Diabetes centrum, s.r.o., Trencin, 911 01, Slovakia|Bloemfontein Medi-Clinic, Bloemfontein, Free State, 9301, South Africa|Dr DR Lakha's Practice, Johannesburg, Gauteng, 1829, South Africa|Midrand Medical Centre, Midrand, Gauteng, 1685, South Africa|Medi-Clinic Heart Hospital, Pretoria, Gauteng, 0083, South Africa|Dr Bhana, Waverley, Gauteng, 2090, South Africa|Dr JH Mynhardt, Kimberley, Northern Cape, 8301, South Africa|Randles Road Medical Centre, Durban, 4091, South Africa|AA Mahomed Medical Centre, Moloto, 1022, South Africa|Changhua Christian Hospital, Changhua City, 500, Taiwan|Far Eastern Memorial Hospital, Division of Endocrinology and Metabolism, New Taipei City, 220, Taiwan|Taichung Veterans General Hospital, Division of Metabolism and Endocrinology, Taichung, 40705, Taiwan|Chi Mei Medical Center, Tainan, 710, Taiwan
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