| Outcome Measures: |
Primary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2, HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration 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, 6, 8, 10, and 12 in the double-blind period., From Baseline to Week 12 | Secondary: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2, Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period., From Baseline to Week 12|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2, Therapeutic glycemic response is defined as HbA1c \<7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin., From Baseline to Week 12|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2, Therapeutic glycemic response is defined as HbA1c \<=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin., From Baseline to Week 12|Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2, Therapeutic glycemic response is defined as HbA1c decrease from baseline \>= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin., From Baseline to Week 12|Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2, Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period., From Baseline to Week 12
|
| Locations: |
Nea Clinic, Jonesboro, Arkansas, 72401, United States|Valley Research, Fresno, California, 93720, United States|Bernstein, Richard, Greenbrae, California, 94904, United States|Jacksonville Center For Clinical Research, Jacksonville, Florida, 32205, United States|Endocrine Research Solutions, Inc., Roswell, Georgia, 30076, United States|Indiana University, Indianapolis, Indiana, 46202, United States|Model Clinical Research Llc, Baltimore, Maryland, 21204, United States|University Of Michigan, Ann Arbor, Michigan, 48109, United States|St. Louis Center For Clinical Research, St. Louis, Missouri, 63128, United States|Suny Upstate Medical University, Syracuse, New York, 13210, United States|Mountain Diabetes And Endocrine Center, Asheville, North Carolina, 28801, United States|Your Diabetes Endocrine Nutrition Group, Mentor, Ohio, 44060, United States|Research Institute Of Dallas, P.A., Dallas, Texas, 75231, United States|Diabetes And Glandular Disease Research Associates, P.A., San Antonio, Texas, 78229, United States|Rainier Clinical Research Center, Renton, Washington, 98055, United States|Advanced Healthcare S.C., Milwaukee, Wisconsin, 53209, United States|Local Institution, Winnipeg, Manitoba, R3E 3P4, Canada|Local Institution, Bathurst, New Brunswick, E2A 4X7, Canada|Local Institution, Gatineau, Quebec, J8V 2P5, Canada|Local Institution, Laval, Quebec, H7T 2P5, Canada|Local Institution, Longueuil, Quebec, J4N 1L6, Canada|Local Institution, Pointe-Claire, Quebec, H9R 4S3, Canada|Local Institution, Sherbrooke, Quebec, J1G 5K2, Canada
|
