| Outcome Measures: |
Primary: Number of Patients With Treatment Failure, Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents., Baseline to end of Period II (up to 4.5 years)|Time to Treatment Failure, Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents., Baseline to end of Period II (up to 4.5 years) | Secondary: Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3, HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175)., Year 3 in Period II|Change in HOMA-B From Baseline to Endpoint, Change in HOMA-B from baseline to endpoint., Baseline, end of Period II (up to 4.5 years)|Fasting Proinsulin/Insulin Ratio at Year 3, Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3., Year 3 in Period II|Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint., Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint., Baseline, end of Period II (up to 4.5 years)|Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3, DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L)., Year 3 in Period II|Change in DI30/DG30 Ratio From Baseline to Endpoint, Change in DI30/DG30 ratio from baseline to endpoint., Baseline, end of Period II (up to 4.5 years)|Disposition Index at Year 3, Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175)., Year 3 in Period II|Change in Disposition Index From Baseline to Endpoint, Change in disposition index from baseline to endpoint., Baseline, end of Period II (up to 4.5 years)|Change in HbA1c From Baseline to Year 3, Change in HbA1c from baseline to Year 3., Baseline, Year 3 in Period II|Change in HbA1c From Baseline to Endpoint, Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study)., Baseline, end of Period II (up to 4.5 years)|Fasting Plasma Glucose at Year 3, Fasting plasma glucose at Year 3., Year 3 in Period II|Change in Fasting Plasma Glucose From Baseline to Endpoint, Change in fasting plasma glucose from baseline to endpoint., Baseline, end of Period II (up to 4.5 years)|Postprandial (2 Hours) Plasma Glucose at Year 3, Postprandial (2 hours) plasma glucose at Year 3., Year 3 in Period II|Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint, Change from baseline in postprandial (2 hours) plasma glucose to endpoint., Baseline, end of Period II (up to 4.5 years)|Change in Body Weight From Baseline to Year 3, Change in Body weight from baseline to Year 3., Baseline, Year 3 in Period II|Systolic Blood Pressure at Year 3, Systolic Blood pressure at Year 3., Year 3 in Period II|Diastolic Blood Pressure at Year 3, Diastolic Blood pressure at Year 3., Year 3 in Period II|Heart Rate at Year 3, Heart rate at Year 3., Year 3 in Period II|Triglycerides at Year 3, Triglycerides at Year 3., Year 3 in Period II|Total Cholesterol at Year 3, Total Cholesterol at Year 3., Year 3 in Period II|High-density Lipoprotein (HDL) Cholesterol at Year 3, HDL Cholesterol at Year 3., Year 3 in Period II|Hypoglycemia Rate Per Year, All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration \<=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration \<=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination., Baseline to end of Period II (up to 4.5 years)|Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III, Change in HbA1c from baseline to Year 2., Baseline in Period III, Year 2 in Period III|Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III, Change in HbA1c from baseline to Year 2., Baseline in Period III, Year 2 in Period III|Hypoglycemia Rate Per Year in Period III, All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration \<=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration \<=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination., Start of Period III to end of study
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| Locations: |
Research Site, Graz, Austria|Research Site, Innsbruck, Austria|Research Site, Salzburg, Austria|Research Site, Vienna, Austria|Research Site, Beroun, Czech Republic|Research Site, Ceske Budejovice, Czech Republic|Research Site, Hradec Kralove, Czech Republic|Research Site, Liberec, Czech Republic|Research Site, Pisek, Czech Republic|Research Site, Praha, Czech Republic|Research Site, Trebic, Czech Republic|Research Site, Helsinki, Finland|Research Site, Kuopio, Finland|Research Site, Pori, Finland|Research Site, Vaasa, Finland|Research Site, Alencon, France|Research Site, Bois-Guillaume, France|Research Site, Bourg des Comptes, France|Research Site, Broglie, France|Research Site, Bron, France|Research Site, Fleville Devant Nancy, France|Research Site, Le Creusot, France|Research Site, Le Mans, France|Research Site, Loudun, France|Research Site, Montigny les Metz, France|Research Site, Nevers, France|Research Site, Strasbourg, France|Research Site, Thouars, France|Research Site, Tours, France|Research Site, Valreas, France|Research Site, Vihiers, France|Research Site, Vénissieux, France|Research Site, Aschaffenburg, Germany|Research Site, Dresden, Germany|Research Site, Eisenach, Germany|Research Site, Essen Schonnebeck, Germany|Research Site, Essen, Germany|Research Site, Falkensee, Germany|Research Site, Fulda, Germany|Research Site, Hamburg-Altona, Germany|Research Site, Hamburg-Ottmarschen, Germany|Research Site, Hamburg, Germany|Research Site, Heidelberg, Germany|Research Site, Leipzig, Germany|Research Site, Munster, Germany|Research Site, Saarbrucken, Germany|Research Site, Schenklengsfeld, Germany|Research Site, Schkeuditz, Germany|Research Site, St. Ingbert, Germany|Research Site, Staffelstein, Germany|Research Site, Witten, Germany|Research Site, Budapest, Hungary|Research Site, Gyula, Hungary|Research Site, Kecskemet, Hungary|Research Site, Veszprem, Hungary|Research Site, Zalaegerszeg, Hungary|Research Site, County Galway, Ireland|Research Site, County Waterford, Ireland|Research Site, Dublin, Ireland|Research Site, Haifa, Israel|Research Site, Holon, Israel|Research Site, Jerusalem, Israel|Research Site, Tel Hashomer, Israel|Research Site, Ancona, Italy|Research Site, Arenzano, Italy|Research Site, Atri, Italy|Research Site, Bergamo, Italy|Research Site, Catanzaro, Italy|Research Site, Firenze, Italy|Research Site, Foggia, Italy|Research Site, Forli, Italy|Research Site, Genova, Italy|Research Site, Grosseto, Italy|Research Site, Milano, Italy|Research Site, Monserrato (Cagliari), Italy|Research Site, Napoli, Italy|Research Site, Palermo, Italy|Research Site, Perugia, Italy|Research Site, Pescara, Italy|Research Site, Pisa, Italy|Research Site, Ravenna, Italy|Research Site, Roma, Italy|Research Site, San Benedetto del Tronto, Italy|Research Site, Siena, Italy|Research Site, Treviso, Italy|Research Site, Verona, Italy|Research Site, Mexico City, Distrito Federal, Mexico|Research Site, Celaya, Guanajuato, Mexico|Research Site, Pachuca, Hidalgo, Mexico|Research Site, Monterrey, Nuevo Leon, Mexico|Research Site, Bialystok, Poland|Research Site, Bydgoszcz, Poland|Research Site, Lublin, Poland|Research Site, Szczecin, Poland|Research Site, Warszawa, Poland|Research Site, Wroclaw, Poland|Research Site, Barcelona, Spain|Research Site, Madrid, Spain|Research Site, Fribourg, Switzerland|Research Site, Geneva, Switzerland|Research Site, Geneve, Switzerland|Research Site, Lausanne, Switzerland|Research Site, Luzern, Switzerland|Research Site, Bath, United Kingdom|Research Site, Belfast, United Kingdom|Research Site, Brandford on Avon, United Kingdom|Research Site, County Antrim, United Kingdom|Research Site, Downpatrick, United Kingdom|Research Site, Frome, United Kingdom|Research Site, Midsomer Norton, United Kingdom|Research Site, Omagh, United Kingdom|Research Site, Penzance, United Kingdom|Research Site, Plymouth, United Kingdom|Research Site, Southdown, United Kingdom|Research Site, Wiltshire, United Kingdom
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