| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c), HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment\*time as fixed effects., Baseline, Week 18 | Secondary: Percentage of Participants With HbA1c of <7.0%, Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time., Week 18|Change From Baseline in Fasting Serum Glucose (FSG), Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using \>=8% as cutoff, treatment, time, treatment\*time as fixed effects., Baseline, Week 18|Change From Baseline in Body Weight, Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using \>=8% as cutoff, treatment, time, treatment\*time as fixed effects., Baseline, Week 18|Percentage of Participants Discontinuing Study Drug Due to Adverse Events, Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation., Baseline through Week 18|Rate of Documented Symptomatic Hypoglycemia, Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter \[mmol/L\]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset., Week 18|Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide, Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported., 0, 2, 4, 6, 10, 18, 22 weeks and early termination|Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide, AUC\[0-168h\] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit., 0, 2, 4, 6, 10, 18, 22 weeks and early termination
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| Locations: |
Parexel Early Phase Unit at Glendale, Glendale, California, 91206-4140, United States|Marin Endocrine Associates, Greenbrae, California, 94904, United States|National Research Institute, Huntington Park, California, 90255, United States|National Research Institute, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|Artemis Institute for Clinical Research, San Diego, California, 92103, United States|Encompass Clinical Research, Spring Valley Lake, California, 91978, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Infosphere, Van Nuys, California, 91405, United States|Diablo Clinical Research, Walnut Creek, California, 94598, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Axes Medical Research, LLC, Cooper City, Florida, 33024, United States|Clinical Research of South Florida, Coral Gables, Florida, 33134, United States|East Coast Institute For Research, Jacksonville, Florida, 32204, United States|Suncoast Research Group, LLC, Miami Lakes, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33175, United States|Palm Harbor Medical Associates, Palm Harbor, Florida, 34684, United States|In-Quest Medical Research, LLC - Norcross, Norcross, Georgia, 30071, United States|East West Medical Institute, Honolulu, Hawaii, 96814, United States|Elite Cilnical Trials LLLP, Blackfoot, Idaho, 83221, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|HSHS Medical Group Diabetes Research, Springfield, Illinois, 62711, United States|American Health Network, Indianapolis, Indiana, 46254, United States|Iderc, P.L.C., Des Moines, Iowa, 50314, United States|Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606, United States|ActivMed Practices & Research, Inc, Methuen, Massachusetts, 01844, United States|StudyMetrix Research, LLC, Saint Peters, Missouri, 63303, United States|Manhattan Medical Research, New York Mills, New York, 10016, United States|High Point Clinical Trials Center, High Point, North Carolina, 27265, United States|Aventiv Research, Columbus, Ohio, 43213, United States|The Corvallis Clinic P.C., Corvallis, Oregon, 97330, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|New Phase Research & Development, Knoxville, Tennessee, 37909, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Consano Clinical Research, San Antonio, Texas, 78231, United States|Clinpoint Trial, LLC, Waxahachie, Texas, 75165, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|Rainier Clinical Research Center, Renton, Washington, 98057, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Brandýs Nad Labem-Stará Boleslav, 25001, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Krnov, 79401, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Praha 1, 11000, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Praha 4 - Krc, 140 59, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Praha 4, 149 00, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Praha 8, 181 00, Czechia|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chihuahua, 31217, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cuernavaca, 62250, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Guadalajara, 04460, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Monterrey, 64460, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tampico, 89000, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bialystok, 15-404, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bialystok, 15-445, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gdansk, 80-546, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lodz, 90-242, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lublin, 20-333, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lublin, 20-538, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Poznan, 61-655, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Poznan, 61-853, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ruda Slaska, 41-709, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Szczecin, 70-506, Poland|Marginal Doctor's Center, Manati, 00674, Puerto Rico|American Telemedicine Center, San Juan, 00917, Puerto Rico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Alba Iulia, 510053, Romania|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Baia Mare, 430222, Romania|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Iasi, 700547, Romania|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Oradea, 410159, Romania|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Satu-Mare, 440055, Romania
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