| Outcome Measures: |
Primary: Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12, Fasted blood samples for HbA1c were collected at Baseline and Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Only those participants with a value at Baseline and at Week 12 (after Last Observation Carried Forward \[LOCF\]) were used for this analysis. Adjusted mean is presented as least square mean., Baseline (Week 0) and Week 12 | Secondary: Change From Baseline in HbA1c (%) at Weeks 4 and 8, Fasted blood samples for HbA1c were collected at Baseline and Weeks 4 and 8. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) and Week 4 and Week 8|Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12, Fasted blood samples for FPG were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) and Week 4, Week 8 and Week 12|Change From Baseline to Week 12 in Fructosamine, Fasted blood samples for fructosamine were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) to Week 12|Change From Baseline to Week 12 in Fasting Insulin, Fasted blood samples for insulin were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) to Week 12|Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG ≥1.7 mmol/L, Fasted blood samples for HbA1c were collected at Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Number of participants at Week 12 with: HbA1c \<= 6.5%, HbA1c \<7.0%; FPG \<7 mmo/L (126 milligram/deciliter \[mg/dL\]), FPG \<7.8 mmol/L (140 mg/dL); FPG \<5.5 mmol/L (100 mg/dL); a decrease from Baseline of HbA1c \>= 0.7%; a decrease from Baseline of FPG ≥1.7 mmol/L (30 mg/dL) are presented., Week 12|Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]), Fasted samples for TC, LDL-C, HDL-C and TG were collected at Week 12. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent Change based on log-transformed data: 100\*(exponentiated(mean change on log scale)-1), Baseline (Week 0) and Week 4, Week 8 and Week 12|Change From Baseline to Week 12 in Body Weight, Weight of participants was measured from Baseline (Week 0) to Week 12 and recorded in the case report form (CRF). Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) to Week 12|Change From Baseline to Week 12 in Waist Circumference, Waist circumference of participants was measured from Baseline (Week 0) to Week 12 and recorded in the CRF. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) to Week 12|Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine, A 24-hour urine collection was obtained from all participants at Baseline (Week 0) and Week 12 to measure glucose. Participants were provided with urine collection bottles and cooler prior to these visits and instructed that the urine collections must be kept cold and dropped off at the clinic prior to or at the scheduled visits. Site staff queried participants to determine whether the sample represented a full 24-hour collection. The total volume and the sample date and time were recorded. The entire 24-hour urine collection was well mixed in one container and a urine aliquot obtained. Samples were assayed for glucose. The 24-hour collections were used to derive 24-hour urine glucose excretion corrected for filtered load. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) and Week 12 (24-hour urine collection)|Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT), Post-prandial assessments of glucose were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time "0" started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)|Change From Baseline in Insulin AUC During a 2-hour OGTT, Post-prandial assessments of insulin were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time "0" started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) and Week 12 (0 to 2-hour OGTT)|Change From Baseline in C-peptide AUC During a 2-hr OGTT, Post-prandial assessments of C-peptide were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time "0" started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)|Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE), AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant., Up to 12 weeks|Number of Participants With On-therapy Hypoglycemia, Hypoglycemia is low blood glucose or low blood sugar. Hypoglycemic events were collected separately and reported separately from AE, including supplemental data which were not collected for AE. However, any hypoglycemic event which met the criteria for a SAE was included in the SAE summaries. The number of participants in each group that experienced a hypoglycemic event was summarized by frequency of the events., Up to 14 weeks|Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern, Vital signs included heart rate and blood pressure. Heart rate and blood pressure were taken before blood draws were performed. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. Heart rate and blood pressure was measured pre-dose in duplicate at the specified visits, after the participant had been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Heart rate was measured at the same time as blood pressure using the standardized blood pressure equipment that was provided. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Up to 14 weeks|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern, Full 12-lead ECGs were recorded at screening, Baseline (Week 0), Week 4, Week 12 or early withdrawal, and Week 14 (Follow-up) using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT and corrected QT (QTc) intervals. All 12-lead ECGs were read locally by the Investigator or his/her designate and were forwarded electronically to the central reader for interpretation. If the QTc was \>500 milliseconds (msec) on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was \>500 msec, the participant was withdrawn from the study., Up to Early withdrawal (Between Week 12 and Week 14)|Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern, Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. An additional fasting blood sample (serum and plasma) was drawn at Week 0, Week 4, Week 6 and Week 12 or at early withdrawal (up to 14 weeks) and kept in long-term storage for future testing of biomarkers for diabetes and complications of the disease. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values., Up to 14 weeks
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| Locations: |
GSK Investigational Site, Mesa, Arizona, 85206, United States|GSK Investigational Site, Hollywood, Florida, 33023, United States|GSK Investigational Site, Miami, Florida, 33156, United States|GSK Investigational Site, Saint Cloud, Florida, 34769, United States|GSK Investigational Site, Sunset, Louisiana, 70584, United States|GSK Investigational Site, Oxon Hill, Maryland, 20745, United States|GSK Investigational Site, Las Vegas, Nevada, 89016, United States|GSK Investigational Site, Las Vegas, Nevada, 89106, United States|GSK Investigational Site, Las Vegas, Nevada, 89128, United States|GSK Investigational Site, Albuquerque, New Mexico, 87102, United States|GSK Investigational Site, Canal Fulton, Ohio, 44614, United States|GSK Investigational Site, Simpsonville, South Carolina, 29681, United States|GSK Investigational Site, San Antonio, Texas, 78229, United States|GSK Investigational Site, Burke, Virginia, 22015, United States|GSK Investigational Site, Buenos Aries, Buenos Aires, C1425AWC, Argentina|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, C1012AAR, Argentina|GSK Investigational Site, Ciudad Autónoma de Buenos Aires, Buenos Aires, C1117ABH, Argentina|GSK Investigational Site, Cordoba, Córdova, 5000, Argentina|GSK Investigational Site, Buenos Aires, 1425, Argentina|GSK Investigational Site, Cordoba, X5002AOQ, Argentina|GSK Investigational Site, Mendoza, M5500CCG, Argentina|GSK Investigational Site, Quilmes, 1878, Argentina|GSK Investigational Site, Tucuman, 4000, Argentina|GSK Investigational Site, Pleven, 5800, Bulgaria|GSK Investigational Site, Plovdiv, 4000, Bulgaria|GSK Investigational Site, Sofia, 1233, Bulgaria|GSK Investigational Site, Sofia, 1606, Bulgaria|GSK Investigational Site, Varna, 9010, Bulgaria|GSK Investigational Site, Santiago, Región Metro De Santiago, 7500010, Chile|GSK Investigational Site, Santiago, Región Metro De Santiago, 7510605, Chile|GSK Investigational Site, San José, Costa Rica|GSK Investigational Site, Brno, 624 00, Czechia|GSK Investigational Site, Brno, 625 00, Czechia|GSK Investigational Site, Brno, 662 50, Czechia|GSK Investigational Site, Ceske Budejovice, 370 87, Czechia|GSK Investigational Site, Cheb, 350 02, Czechia|GSK Investigational Site, Havirov - Soumbrak, 736 01, Czechia|GSK Investigational Site, Olomouc, 779 00, Czechia|GSK Investigational Site, Prague, 181 00, Czechia|GSK Investigational Site, Praha 5, 15030, Czechia|GSK Investigational Site, Praha 5, 155 00, Czechia|GSK Investigational Site, Praha 5, 158 00, Czechia|GSK Investigational Site, Semily, 513 01, Czechia|GSK Investigational Site, Sumperk, 78752, Czechia|GSK Investigational Site, Usti nad Labem, 40001, Czechia|GSK Investigational Site, Znojmo, 67035, Czechia|GSK Investigational Site, Bammental, Baden-Wuerttemberg, 69245, Germany|GSK Investigational Site, Kippenheim, Baden-Wuerttemberg, 77971, Germany|GSK Investigational Site, Mannheim, Baden-Wuerttemberg, 68161, Germany|GSK Investigational Site, Weinheim, Baden-Wuerttemberg, 69469, Germany|GSK Investigational Site, Haag, Bayern, 83527, Germany|GSK Investigational Site, Hoehenkirchen-Siegertsbrunn, Bayern, 85635, Germany|GSK Investigational Site, Lampertheim, Hessen, 68623, Germany|GSK Investigational Site, Damme, Niedersachsen, 49401, Germany|GSK Investigational Site, Hannover, Niedersachsen, 30161, Germany|GSK Investigational Site, Hildesheim, Niedersachsen, 31139, Germany|GSK Investigational Site, Bergkamen, Nordrhein-Westfalen, 59192, Germany|GSK Investigational Site, Mainz, Rheinland-Pfalz, 55116, Germany|GSK Investigational Site, Rhaunen, Rheinland-Pfalz, 55624, Germany|GSK Investigational Site, Speyer, Rheinland-Pfalz, 67346, Germany|GSK Investigational Site, Berlin, 10787, Germany|GSK Investigational Site, Budapest, 1021, Hungary|GSK Investigational Site, Budapest, 1036., Hungary|GSK Investigational Site, Budapest, 1076, Hungary|GSK Investigational Site, Budapest, 1088, Hungary|GSK Investigational Site, Debrecen, 4043, Hungary|GSK Investigational Site, Erd, 2030, Hungary|GSK Investigational Site, Győr, 9023, Hungary|GSK Investigational Site, Miskolc, 3501, Hungary|GSK Investigational Site, Miskolc, 3530, Hungary|GSK Investigational Site, Mosonmagyaróvár, 9200, Hungary|GSK Investigational Site, Nyirtegyhaza, 4400, Hungary|GSK Investigational Site, Pécs, 7623, Hungary|GSK Investigational Site, Szentes, 6600, Hungary|GSK Investigational Site, Szigetvar, 7900, Hungary|GSK Investigational Site, Szombathely, 9700, Hungary|GSK Investigational Site, Veszprem, 8200, Hungary|GSK Investigational Site, Zalaegerszeg, 8900, Hungary|GSK Investigational Site, Bangalore, 560 054, India|GSK Investigational Site, Bangalore, 560017, India|GSK Investigational Site, Bangalore, 560034, India|GSK Investigational Site, Kochi, 682026, India|GSK Investigational Site, Mumbai, 400007, India|GSK Investigational Site, New Delhi, 110065, India|GSK Investigational Site, Pune, 411004, India|GSK Investigational Site, Jelgava, LV 3001, Latvia|GSK Investigational Site, Limbazi, LV 4001, Latvia|GSK Investigational Site, Riga, LV 1002, Latvia|GSK Investigational Site, Riga, LV 1011, Latvia|GSK Investigational Site, Riga, LV 1012, Latvia|GSK Investigational Site, Riga, LV1002, Latvia|GSK Investigational Site, Riga, LV1058, Latvia|GSK Investigational Site, Talsi, LV 3201, Latvia|GSK Investigational Site, Tukums, LV 3100, Latvia|GSK Investigational Site, Kaunas, LT-49335, Lithuania|GSK Investigational Site, Kaunas, LT-50009, Lithuania|GSK Investigational Site, Kaunas, LT-51270, Lithuania|GSK Investigational Site, Vilnius, LT-07156, Lithuania|GSK Investigational Site, Vilnius, LT-08661, Lithuania|GSK Investigational Site, Tijuana, Baja California Norte, 22320, Mexico|GSK Investigational Site, Mexico City, Estado De México, 14000, Mexico|GSK Investigational Site, Monterrey, Nuevo León, 64460, Mexico|GSK Investigational Site, Durango, 34079, Mexico|GSK Investigational Site, Mexico, 03100, Mexico|GSK Investigational Site, Mexico, 14080, Mexico|GSK Investigational Site, Auckland, 1311, New Zealand|GSK Investigational Site, Auckland, 1701, New Zealand|GSK Investigational Site, Hamilton, 2001, New Zealand|GSK Investigational Site, Rotorua, 3201, New Zealand|GSK Investigational Site, Lima, Lima 1, Peru|GSK Investigational Site, Lima, Lima 29, Peru|GSK Investigational Site, Bydgoszcz, 85-021, Poland|GSK Investigational Site, Grudziadz, 86-300, Poland|GSK Investigational Site, Lodz, 90-153, Poland|GSK Investigational Site, Porabka, 43-353, Poland|GSK Investigational Site, Siemianowice Slaskie, 41-103, Poland|GSK Investigational Site, Wroclaw, 50-349, Poland|GSK Investigational Site, Ponce, 00717, Puerto Rico|GSK Investigational Site, Brasov, 500334, Romania|GSK Investigational Site, Bucharest, 020045, Romania|GSK Investigational Site, Deva, 330084, Romania|GSK Investigational Site, Iasi, 700514, Romania|GSK Investigational Site, Moscow, 115446, Russian Federation|GSK Investigational Site, Moscow, 117 036, Russian Federation|GSK Investigational Site, Moscow, 125367, Russian Federation|GSK Investigational Site, Moscow, 127411, Russian Federation|GSK Investigational Site, St. Petersburg, 197110, Russian Federation|GSK Investigational Site, St.-Petersburg, 194354, Russian Federation|GSK Investigational Site, Tomsk, 634009, Russian Federation|GSK Investigational Site, Tumen, 625023, Russian Federation|GSK Investigational Site, Ufa, 450083, Russian Federation|GSK Investigational Site, Bellville, 7530, South Africa|GSK Investigational Site, Gauteng, 1459, South Africa|GSK Investigational Site, Orangegrove, Linksfield West, 2192, South Africa|GSK Investigational Site, Parow, 7505, South Africa|GSK Investigational Site, Roodepoort, 1709, South Africa
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