| Outcome Measures: |
Primary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]), HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period., From Baseline to Week 24 | Secondary: Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication., From Baseline to Week 24|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period., From Baseline to Week 24|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin., From Baseline to Week 24|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline HbA1c ≥9.0% at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. HbA1c was measured as percent of hemoglobin by a central laboratory. The population included those randomized participants who received treatment and had a baseline HbA1c \> 9.0%. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication., From Baseline to Week 24|Adjusted Mean Change From Baseline in Total Body Weight at Week 24 in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined.) Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in Periods and on Day 1 and Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 of the double-blind period., From Baseline to Week 24|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) in Participants With Baseline Body Mass Index (BMI) ≥27 kg/m^2 at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted for baseline HbA1c. HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication were excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication., From Baseline to Week 24|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 1 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Data after rescue medication was excluded from this analysis. Fasting plasma glucose was measured by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication., From Baseline to Week 1|Adjusted Percentage of Participants Achieving Hemoglobin A1c (HbA1C) ≤6.5% at Week 24 (Last Observation Carried Forward [LOCF]), Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Percent adjusted for baseline HbA1c. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin., From Baseline to Week 24 | Other: Number of Participants With Adverse Events (AEs), Hypoglycemia Events, Related AEs, Death as Outcome, Serious AEs (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs Leading to Discontinuation, and Hypoglycemia Events Leading to Discontinuation, AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or missing relationship to study drug. Events captured from baseline to last dose plus 4 days for AEs and plus 30 days for SAEs during the double-blind 12-week period. Data after rescue included., From Baseline to end of Long-term Period (Week 102)|Number of Participants With Laboratory Test Results Meeting the Criteria for Laboratory Abnormality, BUN=blood urea nitrogen; preRX=pretreatment; ULN=upper limit of normal; AST=aspartate aminotransferase; ALT=alanine aminotransferase; ALP=alkaline phosphatase. Phosphorus, inorganic (low): ages 17-65 years, ≤1.8 mg/dL; ages≥66 years, ≤2.1 mg/dL. Phosphorus, inorganic (high): ages 17-65 years, ≥5.6 mg/dL; ages≥66 years, ≥5.6 mg/dL. Phosphorus, inorganic (low) ≤1.8 mg/dL if age 17-65 or ≤2.1 mg/dL if age ≥66. Calcium, total (high): ≥1 mg/dL from ULN and ≥0.5 mg/dL from preRx value., Day 1 to Week 102|Number of Participants With Changes in Baseline in Electrocardiogram Findings at Week 102 (Last Observation Carried Forward [LOCF]), 12-Lead electrocardiograms (ECGs) were performed at entry into lead-in period Day -7 visit and Week 24/dnd of treatment visit (LOCF) on participants who were supine. ECGs were assessed by the investigator. Baseline was Day -7 for this parameter. Data after rescue included.The Week 102 value is the last observation, regardless of rescue prior to Week 102 if no Week 102 measurement was available., Baseline to Week 102|Mean Changes From Baseline in Seated Systolic Blood Pressure, Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication., From Baseline to Week 102|Mean Changes From Baseline in Seated Diastolic Blood Pressure, Blood pressure values were obtained after the participant was seated quietly for 5 minutes; at least 8 hours after the last ingestion of caffeine, alcohol, or nicotine; and in the same arm (right or left) consistently through out the study. Data after rescue were also included. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication., From Baseline to Week 102|Number of Participants With Orthostatic Hypotension, Orthostatic hypotension was defined as a decrease from supine to standing blood pressure of \>20 mm Hg in systolic blood pressure or \>10 mm Hg in diastolic blood pressure., From Baseline to Week 102
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| Locations: |
Clinical Research Advantage / Desert Clinical Res, Llc, Tempe, Arizona, 85282, United States|Medical Group Of Encino, Encino, California, 91436, United States|Valley Research, Fresno, California, 93720, United States|Randall Shue, D.O., Los Angeles, California, 90023, United States|Diabetes Medical Center Of California, Northridge, California, 91325, United States|Ritchken & First M.D.'S, San Diego, California, 92117, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Raikhel, Marina, Torrance, California, 90505, United States|Express Care Clinical Res, Colorado Springs, Colorado, 80909, United States|Denver Internal Medicine, Denver, Colorado, 80209, United States|New West Physicians, Golden, Colorado, 80401, United States|Central Florida Clinical Trials, Inc., Altamonte Springs, Florida, 32701, United States|Family Care Associates Of Nw Florida, Chipley, Florida, 32428, United States|Health Partners Research Foundation, Minneapolis, Minnesota, 56440, United States|Woodlake Research, Chesterfield, Missouri, 63017, United States|Nevada Alliance Against Diabetes, Las Vegas, Nevada, 89101, United States|Diabetes & Endocrinology Consultants, Pc, Morehead City, North Carolina, 28557, United States|Newark Physician Associates, Newark, Ohio, 43055, United States|Integris Family Care S. Penn, Oklahoma City, Oklahoma, 73159, United States|Cumberland Valley Endocrinology Center, Llc, Carlisle, Pennsylvania, 17013, United States|Banksville Medical Pc, Pittsburgh, Pennsylvania, 15216, United States|Palmetto Clinical Research, Summerville, South Carolina, 29485, United States|Southeastern Research Assoc, Taylors, South Carolina, 29687, United States|Texas Center For Drug Development, P.A., Houston, Texas, 77081, United States|Diabetes & Glandular Disease Research Associates, Inc., San Antonio, Texas, 78229, United States|S.A.M. Clinical Research Center, San Antonio, Texas, 78229, United States|Optimum Clinical Research, Salt Lake City, Utah, 84102, United States|Office Of Dr. Gray, Spokane, Washington, 99216, United States|Local Institution, Capital Federal, Buenos Aires, 1034, Argentina|Local Institution, Capital Federal, Buenos Aires, 1429, Argentina|Local Institution, Capital Federal, Buenos Aires, C1056ABJ, Argentina|Local Institution, Capital Federal, Buenos Aires, C1425AGC, Argentina|Local Institution, Ciudad Auton., Buenos Aires, C1505CWB, Argentina|Local Institution, Ciudad Auton, Buenos Aires, C1408INH, Argentina|Local Institution, Mar Del Plata, Buenos Aires, 7600, Argentina|Local Institution, Zarate, Buenos Aires, 2800, Argentina|Local Institution, Villa Carlos Paz, Cordoba, 5152, Argentina|Local Institution, Buenos Aires, 1431, Argentina|Local Institution, Cordoba, 5000, Argentina|Local Institution, Fortaleza, Ceara, 60021, Brazil|Local Institution, Itajuba, Minas Gerais, 37502, Brazil|Local Institution, Belem, Para, 66073, Brazil|Local Institution, Caxias Do Sul, Rio Grande Do Sul, 95070, Brazil|Local Institution, Porto Alegre, Rio Grande Do Sul, 90020090, Brazil|Local Institution, Porto Alegre, Rio Grande Do Sul, 90035, Brazil|Local Institution, Marilia, Sao Paulo, 17519, Brazil|Local Institution, Rio De Janeiro, 20211, Brazil|Local Institution, Calgary, Alberta, T2R 0X7, Canada|Local Institution, Kelowna, British Columbia, V1Y 2H4, Canada|Local Institution, Winnipeg, Manitoba, R3E 3P4, Canada|Local Institution, Bathurst, New Brunswick, E2A 4X7, Canada|Local Institution, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Local Institution, St-John, Newfoundland and Labrador, A1E 2E2, Canada|Local Institution, Sarnia, Ontario, N7T 4X3, Canada|Local Institution, Thornhill, Ontario, L4J 8L7, Canada|Local Institution, Toronto, Ontario, M4R 2G4, Canada|Local Institution, Toronto, Ontario, M9W 4L6, Canada|Local Institution, Charlottetown, Prince Edward Island, C1A 5Y9, Canada|Local Institution, Drummondville, Quebec, J2B 7T1, Canada|Local Institution, Granby, Quebec, J2G 8Z9, Canada|Local Institution, L'Ancienne Lorette, Quebec, G2E 2X1, Canada|Local Institution, Mirabel, Quebec, J7J 2K8, Canada|Local Institution, St-Leonard, Quebec, H1S 3A9, Canada|Local Institution, Saskatoon, Saskatchewan, S7K 3H3, Canada|Local Institution, Saskatoon, Saskatchewan, S7K 7H9, Canada|Local Institution, Df, Distrito Federal, 11800, Mexico|Local Institution, Guadalajara, Distrito Federal, 44670, Mexico|Local Institution, Zapopan, Distrito Federal, 45150, Mexico|Local Institution, Guadalajara, Jalisco, 44650, Mexico|Local Institution, Guadalajara, Jalisco, 44670, Mexico|Local Institution, Monterrey, Nuevo Leon, 64460, Mexico|Local Institution, Monterrey, Nuevo Leon, 64710, Mexico|Local Institution, Monterrrey, Nuevo Leon, 64700, Mexico|Local Institution, Tampico, Tamaulipas, 89109, Mexico|Local Institution, Durango, 64710, Mexico
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