| Outcome Measures: |
Primary: Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30, Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline)., Baseline, 30 weeks | Secondary: Percentage of Participants Achieving HbA1C < 7.0%, Percentage of participants achieving HbA1C \< 7.0%, Week 30|Percent of Participants Achieving HbA1c ≤ 6.5%., Percent of participants achieving HbA1c ≤ 6.5%., Week 30|Change in Fasting Blood Glucose (FBG) From Baseline to Week 30., Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects., Baseline, Week 30|Change in Total Cholesterol From Baseline to Week 30, Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate., Baseline, week 30|Change in High Density Lipoprotein (HDL) From Baseline to Week 30, Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate., Baseline, week 30|Change in Low Density Lipoprotein (LDL) From Baseline to Week 30, Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate., Baseline, Week 30|Change in Body Weight From Baseline to Week 30., Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects., baseline, week 30|Change in Systolic Blood Pressure (SBP) From Baseline to Week 30, Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects., Baseline, Week 30|Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30, Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects., baseline, Week 30|Daily Insulin Glargine Dose at Baseline and at Week 30, Daily Insulin Glargine Dose at baseline and at Week 30, Baseline, week 30|Major Hypoglycemia Rate Per Year, Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and requiring the assistance of another person because of severe impairment in consciousness or behavior., 30 weeks|Minor Hypoglycemia Rate Per Year, Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL), 30 weeks
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| Locations: |
Research Site, Buenos Aires, Argentina|Research Site, Caba, Argentina|Research Site, Capital Federal, Argentina|Research Site, Ciudad Autonoma de Buenos Aire, Argentina|Research Site, Ciudad de Buenos Aires, Argentina|Research Site, Corrientes, Argentina|Research Site, Rosario, Argentina|Research Site, San Rafael, Argentina|Research Site, Arlon, Belgium|Research Site, Bonheiden, Belgium|Research Site, Edegem, Belgium|Research Site, Merksem, Belgium|Research Site, Tallinn, Estonia|Research Site, Tartu, Estonia|Research Site, Helsinki, Finland|Research Site, Oulu, Finland|Research Site, Vantaa, Finland|Research Site, Angers, France|Research Site, Auxerre, France|Research Site, Bar Le Duc, France|Research Site, Douai Cedex, France|Research Site, La Roche Sur Yon, France|Research Site, La Rochelle Cedex 1, France|Research Site, Le Creuzot, France|Research Site, Lille Cedex, France|Research Site, Marseille Cedex 20, France|Research Site, Montpellier Cedex 5, France|Research Site, Nanterre, France|Research Site, Pessac Cedex, France|Research Site, Rennes Cedex 2, France|Research Site, Strasbourg, France|Research Site, Toulouse Cedex 9, France|Research Site, Venissieux, France|Research Site, Bad Lauterberg, Germany|Research Site, Dippoldiswalde, Germany|Research Site, Friedrichsthal, Germany|Research Site, Goch, Germany|Research Site, Grevenbroich, Germany|Research Site, Hamburg, Germany|Research Site, Mainz, Germany|Research Site, Saarbruecken, Germany|Research Site, Athens, Greece|Research Site, Thessaloniki, Greece|Research Site, Firenze, Italy|Research Site, Napoli, Italy|Research Site, Olbia, Italy|Research Site, Perugia, Italy|Research Site, Trieste, Italy|Research Site, Verona, Italy|Research Site, Seoul, Korea, Republic of|Research Site, Ulsan-Si, Korea, Republic of|Research Site, Wonju-Si, Korea, Republic of|Research Site, Aguascalientes, Mexico|Research Site, Cuernavaca, Mexico|Research Site, Mexico City, Mexico|Research Site, Monterrey, Mexico|Research Site, Almere, Netherlands|Research Site, Amsterdam, Netherlands|Research Site, Beek, Netherlands|Research Site, Den Haag, Netherlands|Research Site, Groningen, Netherlands|Research Site, Heerlen, Netherlands|Research Site, Hoogeveen, Netherlands|Research Site, Sittard-Geleen, Netherlands|Research Site, Coimbra, Portugal|Research Site, Lisboa, Portugal|Research Site, Lisbon, Portugal|Research Site, Portugal, Portugal|Research Site, Hato Rey, Puerto Rico|Research Site, Bucharest, Romania|Research Site, Bucuresti, Romania|Research Site, Cluj-Napoca, Romania|Research Site, Constanta, Romania|Research Site, Craiova, Romania|Research Site, Oradea, Romania|Research Site, Ploiesti, Romania|Research Site, Arkhangelsk, Russian Federation|Research Site, Rostov-on-Don, Russian Federation|Research Site, St. Petersburg, Russian Federation|Research Site, Alicante, Spain|Research Site, Barcelona, Spain|Research Site, Dos Hermanas, Spain|Research Site, La Coruna, Spain|Research Site, Santander, Spain|Research Site, Valencia, Spain|Research Site, Halmstad, Sweden|Research Site, Karlstad, Sweden|Research Site, Lund, Sweden|Research Site, Malmo, Sweden|Research Site, Solna, Sweden|Research Site, Stockholm, Sweden|Research Site, Umea, Sweden|Research Site, Bournemouth, United Kingdom|Research Site, Ipswich, United Kingdom|Research Site, Leicester, United Kingdom|Research Site, Penarth, United Kingdom|Research Site, Wakefield, United Kingdom
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