| Outcome Measures: |
Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16, HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Week 16 | Secondary: Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16, HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16, The number of participants who achieved target values for HbA1c (i.e., HbA1c \<6.5% and \>=6.5% to \<7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16|Change From Baseline in Waist Circumference at Week 16, The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Week 16|Change From Baseline in Body Weight at Week 16, The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Week 16|Percent Change From Baseline in Body Weight at Week 16, The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the (\[value at Week 16 minus the Baseline value\] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Week 16|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16, The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16|Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16, Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Weeks 5, 8, 12, and 16|Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16, Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Weeks 5, 8, 12, and 16|Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16, Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Weeks 5, 8, 12, and 16|Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16, Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Weeks 5, 8, 12, and 16|Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16, Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing., Baseline and Weeks 5, 8, 12, and 16|Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16, The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life., Baseline and Week 16|Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16, The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, "In the past week I was hungry"; Q2, "In the past week I thought about food"; Q3, "In the past week I wanted to eat"; Q4, "In the past week I ate more than I should have"; Q5, "In the past week, I craved specific food"; Q6, "In the past week when finished meals I felt full"; Q7, "In the past week when finished meals I felt satisfied.", Week 16|Mean Clearance of Albiglutide, Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration., Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|Mean Volume of Distribution of Albiglutide, Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration., Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|Mean Absorption Rate of Albiglutide, Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration., Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27|Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG, EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model., Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
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| Locations: |
GSK Investigational Site, Anniston, Alabama, 36207, United States|GSK Investigational Site, Birmingham, Alabama, 35233, United States|GSK Investigational Site, Mobile, Alabama, 36617, United States|GSK Investigational Site, Bull Shoals, Arizona, 72619, United States|GSK Investigational Site, Glendale, Arizona, 85306, United States|GSK Investigational Site, Jonesboro, Arizona, 72401, United States|GSK Investigational Site, Phoenix, Arizona, 85032, United States|GSK Investigational Site, Harrisburg, Arkansas, 72432, United States|GSK Investigational Site, Jonesboro, Arkansas, 72401, United States|GSK Investigational Site, Little Rock, Arkansas, 72205, United States|GSK Investigational Site, Little Rock, Arkansas, 72211-3733, United States|GSK Investigational Site, Searcy, Arkansas, 72143, United States|GSK Investigational Site, Castro Valley, California, 94546, United States|GSK Investigational Site, Culver City, California, 90232, United States|GSK Investigational Site, Fullerton, California, 92835, United States|GSK Investigational Site, Garden Grove, California, 92843, United States|GSK Investigational Site, Huntington Beach, California, 92646, United States|GSK Investigational Site, Huntington Beach, California, 92648, United States|GSK Investigational Site, Huntington Park, California, 90255, United States|GSK Investigational Site, Lake Forest, California, 92630, United States|GSK Investigational Site, Loma Linda, California, 92354, United States|GSK Investigational Site, Los Angeles, California, 90022, United States|GSK Investigational Site, Orange, California, 92868, United States|GSK Investigational Site, Redwood City, California, 94062, United States|GSK Investigational Site, Reedley, California, 93654, United States|GSK Investigational Site, Riverside, California, 92506, United States|GSK Investigational Site, Sacramento, California, 95823, United States|GSK Investigational Site, Torrance, California, 90503, United States|GSK Investigational Site, Van Buys, California, 91405, United States|GSK Investigational Site, Ventura, California, 93003, United States|GSK Investigational Site, Victorville, California, 92395, United States|GSK Investigational Site, Denver, Colorado, 80220, United States|GSK Investigational Site, Trumbull, Connecticut, 06611, United States|GSK Investigational Site, Bradenton, Florida, 34205, United States|GSK Investigational Site, Clearwater, Florida, 33756, United States|GSK Investigational Site, Ft. Lauderdale, Florida, 33316, United States|GSK Investigational Site, Gainesville, Florida, 32601, United States|GSK Investigational Site, Jacksonville, Florida, 32204, United States|GSK Investigational Site, Marianna, Florida, 32446, United States|GSK Investigational Site, Miami, Florida, 33144, United States|GSK Investigational Site, Oviedo, Florida, 32765, United States|GSK Investigational Site, Palm Harbor, Florida, 34684, United States|GSK Investigational Site, Plantation, Florida, 33317, United States|GSK Investigational Site, Tallahassee, Florida, 32308, United States|GSK Investigational Site, Tampa, Florida, 33603, United States|GSK Investigational Site, Winter Haven, Florida, 33881, United States|GSK Investigational Site, Winter Park, Florida, 32789, United States|GSK Investigational Site, Athens, Georgia, 30606, United States|GSK Investigational Site, Atlanta, Georgia, 30308, United States|GSK Investigational Site, Atlanta, Georgia, 30312, United States|GSK Investigational Site, Atlanta, Georgia, 30338, United States|GSK Investigational Site, Augusta, Georgia, 30909, United States|GSK Investigational Site, Columbus, Georgia, 31904, United States|GSK Investigational Site, Decatur, Georgia, 30032, United States|GSK Investigational Site, Perry, Georgia, 31069, United States|GSK Investigational Site, Suwanee, Georgia, 30024, United States|GSK Investigational Site, Tucker, Georgia, 30084, United States|GSK Investigational Site, Honolulu, Hawaii, 96813, United States|GSK Investigational Site, Meridian, Idaho, 83642, United States|GSK Investigational Site, Aurora, Illinois, 60504, United States|GSK Investigational Site, Evergreen Park, Illinois, 60805, United States|GSK Investigational Site, La Grange, Illinois, 60525, United States|GSK Investigational Site, Libertyville, Illinois, 60048, United States|GSK Investigational Site, Oak Brook, Illinois, 60523, United States|GSK Investigational Site, Watseka, Illinois, 60970, United States|GSK Investigational Site, Anderson, Indiana, 46011, United States|GSK Investigational Site, Indianapolis, Indiana, 46256, United States|GSK Investigational Site, South Bend, Indiana, 46601, United States|GSK Investigational Site, South Bend, Indiana, 46628, United States|GSK Investigational Site, Ames, Iowa, 50010, United States|GSK Investigational Site, Dubuque, Iowa, 52002, United States|GSK Investigational Site, Kansas City, Kansas, 66160, United States|GSK Investigational Site, Topeka, Kansas, 66606, United States|GSK Investigational Site, Lexington, Kentucky, 40504, United States|GSK Investigational Site, Covington, Louisiana, 70433, United States|GSK Investigational Site, Lacombe, Louisiana, 70433, United States|GSK Investigational Site, Metairie, Louisiana, 70006, United States|GSK Investigational Site, Haverhill, Massachusetts, 01831-2451, United States|GSK Investigational Site, Caro, Michigan, 48723, United States|GSK Investigational Site, Dearborn, Michigan, 48126, United States|GSK Investigational Site, Kalamazoo, Michigan, 49048, United States|GSK Investigational Site, Picayune, Mississippi, 39446, United States|GSK Investigational Site, Rolling Fork, Mississippi, 39159, United States|GSK Investigational Site, Jefferson City, Missouri, 65109, United States|GSK Investigational Site, Springfield, Missouri, 65807, United States|GSK Investigational Site, St. Peters, Missouri, 63376, United States|GSK Investigational Site, Billings, Montana, 59101, United States|GSK Investigational Site, Lincoln, Nebraska, 68516, United States|GSK Investigational Site, North Platte, Nebraska, 69101, United States|GSK Investigational Site, Omaha, Nebraska, 68152, United States|GSK Investigational Site, Las Vegas, Nevada, 89106, United States|GSK Investigational Site, Las Vegas, Nevada, 89128, United States|GSK Investigational Site, Buffalo, New York, 14209, United States|GSK Investigational Site, Glens Falls, New York, 12801, United States|GSK Investigational Site, Rochester, New York, 14609, United States|GSK Investigational Site, Syracuse, New York, 13210, United States|GSK Investigational Site, Williamsville, New York, 14221, United States|GSK Investigational Site, Asheville, North Carolina, 28801, United States|GSK Investigational Site, Chadbourn, North Carolina, 28431, United States|GSK Investigational Site, Charlotte, North Carolina, 28204, United States|GSK Investigational Site, Charlotte, North Carolina, 28227, United States|GSK Investigational Site, Greensboro, North Carolina, 27455, United States|GSK Investigational Site, Mint Hill, North Carolina, 28227, United States|GSK Investigational Site, Raleigh, North Carolina, 27609, United States|GSK Investigational Site, Wilmington, North Carolina, 28401, United States|GSK Investigational Site, Winston-Salem, North Carolina, 27103, United States|GSK Investigational Site, Bismarck, North Dakota, 58503, United States|GSK Investigational Site, Bismarck, North Dakota, 58504, United States|GSK Investigational Site, Fargo, North Dakota, 58104, United States|GSK Investigational Site, Fargo, North Dakota, 58122, United States|GSK Investigational Site, Grand Forks, North Dakota, 58201, United States|GSK Investigational Site, Cleveland, Ohio, 44122, United States|GSK Investigational Site, Columbus, Ohio, 43235, United States|GSK Investigational Site, Toledo, Ohio, 43606, United States|GSK Investigational Site, Oklahoma City, Oklahoma, 73104, United States|GSK Investigational Site, Bend, Oregon, 97701, United States|GSK Investigational Site, Bensalem, Pennsylvania, 19020, United States|GSK Investigational Site, Harrisburg, Pennsylvania, 17112, United States|GSK Investigational Site, Morrisville, Pennsylvania, 19067, United States|GSK Investigational Site, Uniontown, Pennsylvania, 15401, United States|GSK Investigational Site, Watertown, South Dakota, 57201, United States|GSK Investigational Site, Bristol, Tennessee, 37620, United States|GSK Investigational Site, Clarksville, Tennessee, 37043, United States|GSK Investigational Site, Johnson City, Tennessee, 37604, United States|GSK Investigational Site, Knoxville, Tennessee, 37923, United States|GSK Investigational Site, Memphis, Tennessee, 38119, United States|GSK Investigational Site, Milan, Tennessee, 38358, United States|GSK Investigational Site, Nashville, Tennessee, 37203, United States|GSK Investigational Site, Cleburne, Texas, 76033, United States|GSK Investigational Site, Dallas, Texas, 75230, United States|GSK Investigational Site, Euless, Texas, 76040, United States|GSK Investigational Site, Houston, Texas, 77006, United States|GSK Investigational Site, Houston, Texas, 77030, United States|GSK Investigational Site, Houston, Texas, 77056, United States|GSK Investigational Site, Houston, Texas, 77070, United States|GSK Investigational Site, Houston, Texas, 77082, United States|GSK Investigational Site, LaPorte, Texas, 77571, United States|GSK Investigational Site, Lewisville, Texas, 75067, United States|GSK Investigational Site, Longview, Texas, 75605, United States|GSK Investigational Site, Midland, Texas, 79707, United States|GSK Investigational Site, Missouri City, Texas, 77459, United States|GSK Investigational Site, Pasadena, Texas, 77504, United States|GSK Investigational Site, Pearland, Texas, 77584, United States|GSK Investigational Site, Pharr, Texas, 78577, United States|GSK Investigational Site, Round Rock, Texas, 78664, United States|GSK Investigational Site, San Antonio, Texas, 78205, United States|GSK Investigational Site, San Marcos, Texas, 78666, United States|GSK Investigational Site, Spring, Texas, 77379, United States|GSK Investigational Site, Sugar Land, Texas, 77478, United States|GSK Investigational Site, The Woodlands, Texas, 77381, United States|GSK Investigational Site, Tomball, Texas, 77375, United States|GSK Investigational Site, Salt Lake City, Utah, 84107, United States|GSK Investigational Site, South Burlington, Vermont, 05403, United States|GSK Investigational Site, Chester, Virginia, 23836, United States|GSK Investigational Site, Manassas, Virginia, 20110, United States|GSK Investigational Site, Salem, Virginia, 24153, United States|GSK Investigational Site, Madison, Washington, 53717, United States|GSK Investigational Site, Spokane, Washington, 99204, United States|GSK Investigational Site, Concepcion, Región Del Biobio, 4070038, Chile|GSK Investigational Site, Buin, Región Metro De Santiago, 9500645, Chile|GSK Investigational Site, Santiago, Región Metro De Santiago, 7500010, Chile|GSK Investigational Site, Santiago, Región Metro De Santiago, 8320268, Chile|GSK Investigational Site, Santo Domingo, Dominican Republic
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