| 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 was reported., Baseline (Day 1), Week 12 | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 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 less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported., Baseline (Day 1), Week 2, 4, 6, 8|Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12, Baseline (Day 1), Week 2, 4, 6, 8, 12|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 less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent., Week 12|Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data, Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to \[\>=\] 25/50% \[if baseline value was \>200 then percent change of \>25% counts; if baseline value was \<=200 then percent change of \>50% counts\]); 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 of study treatment (up to 101 days)|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode, A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was 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 was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported., Baseline (Day 1) up to Week 14|Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant, Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs., Baseline (Day 1) up to Week 14|Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14, Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)|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: |
Sierra Clinical Research, Roseville, California, 95661, United States|California Research Foundation, San Diego, California, 92103, United States|Diablo Clinical Research, Inc., Walnut Creek, California, 94598, United States|Meridien Research, Bradenton, Florida, 34208, United States|South Broward Research, LLC, Pembroke Pines, Florida, 33027, United States|East-West Medical Research Institute, Honolulu, Hawaii, 96814, United States|Clinical Research Center of Cape Cod, Inc., Hyannis, Massachusetts, 02601, United States|Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States|Sterling Research Group, Ltd., Cincinnati, Ohio, 45246, United States|Community Research, Cincinnati, Ohio, 45255, United States|Coastal Carolina Research Center, Mount Pleasant, South Carolina, 29464, United States|Holston Medical Group, Bristol, Tennessee, 37620, United States|Chattanooga Medical Research, LLC, Chattanooga, Tennessee, 37404, United States|Diagnostic Center, Chattanooga, Tennessee, 37404, United States|University Diabetes and Endocrine Consultants, Chattanooga, Tennessee, 37411, United States|Clinical Research Associates, Inc., Nashville, Tennessee, 37203, United States|Bristol Clinical Research, LLC, Austin, Texas, 78728, United States|DiscoveResearch, Inc., Bryan, Texas, 77802, United States|Dallas Diabetes and Endocrine Center, Dallas, Texas, 75230, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States|National Clinical Research - Norfolk, Inc., Norfolk, Virginia, 23502, United States|National Clinical Research - Richmond, Inc., Richmond, Virginia, 23294, United States|Aurora Advanced Healthcare, Inc., Milwaukee, Wisconsin, 53209, United States|MBAL Yulia Vrevska - Byala, Otdelenie po vatreshni bolesti, Byala, 7100, Bulgaria|MBAL - Ruse AD, Vtoro otdelenie po vatreshni bolesti, Ruse, 7002, Bulgaria|DKTs Akta Medika, Kabinet po endokrinologia, Sevlievo, 5400, Bulgaria|UMBAL Aleksandrovska, Klinika po endokrinologia i bolesti na obmyanata, Sofia, 1431, Bulgaria|VMA - MBAL - Sofia, Klinika po endokrinologia i bolesti na obmyanata, Sofia, 1606, Bulgaria|UMBAL Stara Zagora, Klinika po endokrinologia i bolesti na obmyanata, Stara Zagora, 6003, Bulgaria|Glover Medical Clinic, Langley, British Columbia, V3A 4H9, Canada|Ocean West Research Clinic Inc., Surrey, British Columbia, V3S 2N6, Canada|Rivergrove Medical Clinic, Winnipeg, Manitoba, R2V 4W3, Canada|Aggarwal and Associates Limited, Brampton, Ontario, L6T 0G1, Canada|DCTM CLinical Trials Group Ltd., Strathroy, Ontario, N7G 1Y7, Canada|Manna Research, Toronto, Ontario, M9W 4L6, Canada|Pro-Recherche, St-Romuald, Quebec, G6W 5M6, Canada|Centre de cardiologie et de Recherche Clinique Pierre-Le Gardeur, Terrebonne, Quebec, J6V 1S8, Canada|Alpha Recherche Clinique, Quebec, G3K 2P8, Canada|Dr. Kenessey Albert Korhaz-Rendelointezet/Belgyogyaszat, Balassagyarmat, 2660, Hungary|Synexus Magyarorszag Kft., Budapest, 1036, Hungary|Semmelweis Egyetem/I. sz. Belgyogyaszati Klinika, Budapest, 1083, Hungary|Fejer Megyei Szent Gyorgy Korhaz/II. Belgyogyaszati Osztaly, Szekesfehervar, 8000, Hungary|BGS Global Hospital, Bangalore, Karnataka, 560060, India|Deenanath Mangeshkar Hospital & Research Centre, Pune, Maharashtra, 411 004, India|Diabetes Unit, K.E.M. Hospital Research Centre, Pune, Maharashtra, 411 011, India|Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica, Banska Bystrica, 975 17, Slovakia|Interna A Diabetologicka Ambulancia, Moldava Nad Bodvou, 045 01, Slovakia|FUNKYSTUFF, s.r.o., Nove Zamky, 940 01, Slovakia|MEDIAB, s.r.o., Pezinok, 902 01, Slovakia|MEDIVASA, s.r.o., Zilina, 010 01, Slovakia|China Medical University Hospital, Taichung, 404, Taiwan|National Taiwan University Hospital, Taipei, 100, Taiwan|Taipei Medical University Hospital, Taipei, 110, Taiwan
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