Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naïve and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
| Status | Completed |
| Enrollment | 1405 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. 3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening) Exclusion criteria: 1. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day). 2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2) 3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 1275.1.54001 Boehringer Ingelheim Investigational Site | Caba | |
| Argentina | 1275.1.54005 Boehringer Ingelheim Investigational Site | Capital Federal | |
| Argentina | 1275.1.54003 Boehringer Ingelheim Investigational Site | Cordoba | |
| Argentina | 1275.1.54004 Boehringer Ingelheim Investigational Site | Mar del Plata | |
| Argentina | 1275.1.54002 Boehringer Ingelheim Investigational Site | Mendoza | |
| Australia | 1275.1.61002 Boehringer Ingelheim Investigational Site | East Ringwood | Victoria |
| Australia | 1275.1.61003 Boehringer Ingelheim Investigational Site | Wollongong | New South Wales |
| Brazil | 1275.1.55002 Boehringer Ingelheim Investigational Site | Joaquim Távora | |
| Brazil | 1275.1.55001 Boehringer Ingelheim Investigational Site | Rio de Janeiro - RJ | |
| Brazil | 1275.1.55005 Boehringer Ingelheim Investigational Site | Sao Paulo | |
| Bulgaria | 1275.1.59003 Boehringer Ingelheim Investigational Site | Plovdiv | |
| Bulgaria | 1275.1.59006 Boehringer Ingelheim Investigational Site | Ruse | |
| Bulgaria | 1275.1.59004 Boehringer Ingelheim Investigational Site | Sofia | |
| Canada | 1275.1.20008 Boehringer Ingelheim Investigational Site | Bathurst | New Brunswick |
| Canada | 1275.1.20007 Boehringer Ingelheim Investigational Site | Bay Roberts | Newfoundland and Labrador |
| Canada | 1275.1.20001 Boehringer Ingelheim Investigational Site | Brampton | Ontario |
| Canada | 1275.1.20003 Boehringer Ingelheim Investigational Site | Drummondville | Quebec |
| Canada | 1275.1.20006 Boehringer Ingelheim Investigational Site | Mount Pearl | Newfoundland and Labrador |
| Canada | 1275.1.20002 Boehringer Ingelheim Investigational Site | Pointe Claire | Quebec |
| Canada | 1275.1.20004 Boehringer Ingelheim Investigational Site | St. John's | Newfoundland and Labrador |
| Canada | 1275.1.20005 Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Colombia | 1275.1.57004 Boehringer Ingelheim Investigational Site | Barranquilla | |
| Colombia | 1275.1.57005 Boehringer Ingelheim Investigational Site | Bogota | |
| Colombia | 1275.1.57002 Boehringer Ingelheim Investigational Site | Bogotá | |
| Colombia | 1275.1.57003 Boehringer Ingelheim Investigational Site | Tolima | |
| Denmark | 1275.1.45004 Boehringer Ingelheim Investigational Site | Aalborg | |
| Denmark | 1275.1.45003 Boehringer Ingelheim Investigational Site | Aarhus C | |
| Denmark | 1275.1.45002 Boehringer Ingelheim Investigational Site | København NV | |
| Estonia | 1275.1.37206 Boehringer Ingelheim Investigational Site | Kivioli | |
| Estonia | 1275.1.37202 Boehringer Ingelheim Investigational Site | Pärnu | |
| Estonia | 1275.1.37201 Boehringer Ingelheim Investigational Site | Tallinn | |
| Estonia | 1275.1.37204 Boehringer Ingelheim Investigational Site | Tallinn | |
| Estonia | 1275.1.37203 Boehringer Ingelheim Investigational Site | Viljandi County | |
| Hungary | 1275.1.36002 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 1275.1.36003 Boehringer Ingelheim Investigational Site | Budapest | |
| Hungary | 1275.1.36001 Boehringer Ingelheim Investigational Site | Gyongyos | |
| Italy | 1275.1.39003 Boehringer Ingelheim Investigational Site | Bassano del Grappa (VI) | |
| Italy | 1275.1.39002 Boehringer Ingelheim Investigational Site | Fermo | |
| Italy | 1275.1.39001 Boehringer Ingelheim Investigational Site | Milan | |
| Italy | 1275.1.39004 Boehringer Ingelheim Investigational Site | Roma | |
| Lebanon | 1275.1.96004 Boehringer Ingelheim Investigational Site | Baabda | |
| Lebanon | 1275.1.96002 Boehringer Ingelheim Investigational Site | Beirut | |
| Lebanon | 1275.1.96003 Boehringer Ingelheim Investigational Site | Beirut | |
| Lebanon | 1275.1.96006 Boehringer Ingelheim Investigational Site | Beirut | |
| Lebanon | 1275.1.96008 Boehringer Ingelheim Investigational Site | Beirut | |
| Lebanon | 1275.1.96007 Boehringer Ingelheim Investigational Site | Saida | |
| Malaysia | 1275.1.60001 Boehringer Ingelheim Investigational Site | Kedah | |
| Malaysia | 1275.1.60002 Boehringer Ingelheim Investigational Site | Perak | |
| Mexico | 1275.1.52002 Boehringer Ingelheim Investigational Site | Mexico | |
| Mexico | 1275.1.52005 Boehringer Ingelheim Investigational Site | Mexico | |
| Mexico | 1275.1.52003 Boehringer Ingelheim Investigational Site | Monterrey | |
| Mexico | 1275.1.52001 Boehringer Ingelheim Investigational Site | Pachuca | |
| Mexico | 1275.1.52004 Boehringer Ingelheim Investigational Site | San Luis Potosí | |
| Peru | 1275.1.51001 Boehringer Ingelheim Investigational Site | Arequipa | |
| Peru | 1275.1.51003 Boehringer Ingelheim Investigational Site | Ica | |
| Peru | 1275.1.51002 Boehringer Ingelheim Investigational Site | Lima | |
| Peru | 1275.1.51004 Boehringer Ingelheim Investigational Site | Lima | |
| Peru | 1275.1.51005 Boehringer Ingelheim Investigational Site | Lima | |
| Philippines | 1275.1.63002 Boehringer Ingelheim Investigational Site | Davao | |
| Philippines | 1275.1.63001 Boehringer Ingelheim Investigational Site | Greenhills, San Juan | |
| Philippines | 1275.1.63004 Boehringer Ingelheim Investigational Site | Manila | |
| Philippines | 1275.1.63006 Boehringer Ingelheim Investigational Site | Marikina city | |
| Philippines | 1275.1.63003 Boehringer Ingelheim Investigational Site | Pasay City | |
| Philippines | 1275.1.63005 Boehringer Ingelheim Investigational Site | Pasig | |
| Poland | 1275.1.48002 Boehringer Ingelheim Investigational Site | Lodz | |
| Poland | 1275.1.48004 Boehringer Ingelheim Investigational Site | Poznan | |
| Poland | 1275.1.48001 Boehringer Ingelheim Investigational Site | Warsaw | |
| Poland | 1275.1.48003 Boehringer Ingelheim Investigational Site | Warsaw | |
| Romania | 1275.1.40001 Boehringer Ingelheim Investigational Site | Alba Iulia | |
| Romania | 1275.1.40005 Boehringer Ingelheim Investigational Site | Baia Mare Maramures | |
| Romania | 1275.1.40004 Boehringer Ingelheim Investigational Site | Brasov | |
| Romania | 1275.1.40008 Boehringer Ingelheim Investigational Site | Bucharest | |
| Romania | 1275.1.40009 Boehringer Ingelheim Investigational Site | Bucharest | |
| Romania | 1275.1.40006 Boehringer Ingelheim Investigational Site | Cluj-Napoca | |
| Romania | 1275.1.40007 Boehringer Ingelheim Investigational Site | Galati | |
| Romania | 1275.1.40002 Boehringer Ingelheim Investigational Site | Oradea | |
| Romania | 1275.1.40010 Boehringer Ingelheim Investigational Site | Sibiu | |
| Romania | 1275.1.40003 Boehringer Ingelheim Investigational Site | Targu-Mures | |
| Russian Federation | 1275.1.70006 Boehringer Ingelheim Investigational Site | Arkhangelsk | |
| Russian Federation | 1275.1.70001 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1275.1.70004 Boehringer Ingelheim Investigational Site | Samara | |
| Russian Federation | 1275.1.70002 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Russian Federation | 1275.1.70003 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Russian Federation | 1275.1.70005 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Spain | 1275.1.34004 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1275.1.34005 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1275.1.34002 Boehringer Ingelheim Investigational Site | Hospitalet de Llobegrat | |
| Spain | 1275.1.34003 Boehringer Ingelheim Investigational Site | Palma de Mallorca | |
| Spain | 1275.1.34006 Boehringer Ingelheim Investigational Site | Tarragona | |
| Sweden | 1275.1.46003 Boehringer Ingelheim Investigational Site | Järfälla | |
| Sweden | 1275.1.46004 Boehringer Ingelheim Investigational Site | Rättvik | |
| Sweden | 1275.1.46002 Boehringer Ingelheim Investigational Site | Skene | |
| Taiwan | 1275.1.88006 Chang Gung Memorial Hospital-CY | Chiayi | |
| Taiwan | 1275.1.88007 E-Da Hospital | Kaohsiung | |
| Taiwan | 1275.1.88001 Cardinal Tien Hospital | New Taipei | |
| Taiwan | 1275.1.88004 Taichung Veterans General Hospital | Taichung | |
| Taiwan | 1275.1.88008 Chi Mei Medical Center | Tainan | |
| Taiwan | 1275.1.88002 Far Eastern Memorial Hospital | Taipei | |
| Taiwan | 1275.1.88003 Taipei Chang Gung Memorial Hospital | Taipei | |
| United States | 1275.1.01100 Boehringer Ingelheim Investigational Site | Addison | Illinois |
| United States | 1275.1.01001 Boehringer Ingelheim Investigational Site | Akron | Ohio |
| United States | 1275.1.01057 Boehringer Ingelheim Investigational Site | Albuquerque | New Mexico |
| United States | 1275.1.01084 Boehringer Ingelheim Investigational Site | Altoona | Pennsylvania |
| United States | 1275.1.01011 Boehringer Ingelheim Investigational Site | Asheboro | North Carolina |
| United States | 1275.1.01039 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | 1275.1.01049 Boehringer Ingelheim Investigational Site | Austin | Texas |
| United States | 1275.1.01080 Boehringer Ingelheim Investigational Site | Austin | Texas |
| United States | 1275.1.01002 Boehringer Ingelheim Investigational Site | Binghamton | New York |
| United States | 1275.1.01103 Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | 1275.1.01081 Boehringer Ingelheim Investigational Site | Boston | Massachusetts |
| United States | 1275.1.01008 Boehringer Ingelheim Investigational Site | Bountiful | Utah |
| United States | 1275.1.01015 Boehringer Ingelheim Investigational Site | Brentwood | Tennessee |
| United States | 1275.1.01052 Boehringer Ingelheim Investigational Site | Burlington | North Carolina |
| United States | 1275.1.01086 Boehringer Ingelheim Investigational Site | Cerritos | California |
| United States | 1275.1.01093 Boehringer Ingelheim Investigational Site | Charleston | South Carolina |
| United States | 1275.1.01045 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina |
| United States | 1275.1.01031 Boehringer Ingelheim Investigational Site | Chattanooga | Tennessee |
| United States | 1275.1.01067 Boehringer Ingelheim Investigational Site | Chula Vista | California |
| United States | 1275.1.01032 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
| United States | 1275.1.01061 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
| United States | 1275.1.01116 Boehringer Ingelheim Investigational Site | Cincinnati | Ohio |
| United States | 1275.1.01078 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado |
| United States | 1275.1.01124 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado |
| United States | 1275.1.01016 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | 1275.1.01102 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | 1275.1.01082 Boehringer Ingelheim Investigational Site | Corvallis | Oregon |
| United States | 1275.1.01017 Boehringer Ingelheim Investigational Site | Dayton | Ohio |
| United States | 1275.1.01036 Boehringer Ingelheim Investigational Site | Dayton | Ohio |
| United States | 1275.1.01030 Boehringer Ingelheim Investigational Site | Delaware | Ohio |
| United States | 1275.1.01010 Boehringer Ingelheim Investigational Site | Denver | Colorado |
| United States | 1275.1.01048 Boehringer Ingelheim Investigational Site | Denver | Colorado |
| United States | 1275.1.01042 Boehringer Ingelheim Investigational Site | Des Moines | Iowa |
| United States | 1275.1.01013 Boehringer Ingelheim Investigational Site | Elizabeth | New Jersey |
| United States | 1275.1.01109 Boehringer Ingelheim Investigational Site | Encino | California |
| United States | 1275.1.01020 Boehringer Ingelheim Investigational Site | Endwell | New York |
| United States | 1275.1.01038 Boehringer Ingelheim Investigational Site | Fleetwood | Pennsylvania |
| United States | 1275.1.01122 Boehringer Ingelheim Investigational Site | Florence | South Carolina |
| United States | 1275.1.01095 Boehringer Ingelheim Investigational Site | Flushing | New York |
| United States | 1275.1.01107 Boehringer Ingelheim Investigational Site | Foley | Alabama |
| United States | 1275.1.01012 Boehringer Ingelheim Investigational Site | Fresno | California |
| United States | 1275.1.01073 Boehringer Ingelheim Investigational Site | Gainesville | Florida |
| United States | 1275.1.01062 Boehringer Ingelheim Investigational Site | Glens Falls | New York |
| United States | 1275.1.01033 Boehringer Ingelheim Investigational Site | Great Falls | Montana |
| United States | 1275.1.01055 Boehringer Ingelheim Investigational Site | Groveport | Ohio |
| United States | 1275.1.01050 Boehringer Ingelheim Investigational Site | Harbor City | California |
| United States | 1275.1.01099 Boehringer Ingelheim Investigational Site | Henderson | Nevada |
| United States | 1275.1.01063 Boehringer Ingelheim Investigational Site | Hialeah | Florida |
| United States | 1275.1.01077 Boehringer Ingelheim Investigational Site | Hialeah | Florida |
| United States | 1275.1.01005 Boehringer Ingelheim Investigational Site | Hodges | South Carolina |
| United States | 1275.1.01029 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1275.1.01053 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1275.1.01106 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1275.1.01056 Boehringer Ingelheim Investigational Site | Huntington Park | California |
| United States | 1275.1.01125 Boehringer Ingelheim Investigational Site | Hyattsville | Maryland |
| United States | 1275.1.01090 Boehringer Ingelheim Investigational Site | Inverness | Florida |
| United States | 1275.1.01054 Boehringer Ingelheim Investigational Site | Jacksonville | Florida |
| United States | 1275.1.01101 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada |
| United States | 1275.1.01114 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada |
| United States | 1275.1.01123 Boehringer Ingelheim Investigational Site | Las Vegas | Nevada |
| United States | 1275.1.01028 Boehringer Ingelheim Investigational Site | Little Rock | Arkansas |
| United States | 1275.1.01021 Boehringer Ingelheim Investigational Site | Long Beach | California |
| United States | 1275.1.01024 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1275.1.01112 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1275.1.01092 Boehringer Ingelheim Investigational Site | Maitland | Florida |
| United States | 1275.1.01007 Boehringer Ingelheim Investigational Site | Marietta | Georgia |
| United States | 1275.1.01121 Boehringer Ingelheim Investigational Site | Memphis | Tennessee |
| United States | 1275.1.01089 Boehringer Ingelheim Investigational Site | Mesa | Arizona |
| United States | 1275.1.01065 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1275.1.01110 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1275.1.01040 Boehringer Ingelheim Investigational Site | Miami Beach | Florida |
| United States | 1275.1.01025 Boehringer Ingelheim Investigational Site | Miami Lakes | Florida |
| United States | 1275.1.01043 Boehringer Ingelheim Investigational Site | Mobile | Alabama |
| United States | 1275.1.01066 Boehringer Ingelheim Investigational Site | Mobile | Alabama |
| United States | 1275.1.01006 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1275.1.01111 Boehringer Ingelheim Investigational Site | Norcross | Georgia |
| United States | 1275.1.01034 Boehringer Ingelheim Investigational Site | Norman | Oklahoma |
| United States | 1275.1.01083 Boehringer Ingelheim Investigational Site | Oceanside | California |
| United States | 1275.1.01094 Boehringer Ingelheim Investigational Site | Orlando | Florida |
| United States | 1275.1.01068 Boehringer Ingelheim Investigational Site | Ormond Beach | Florida |
| United States | 1275.1.01059 Boehringer Ingelheim Investigational Site | Paducah | Kentucky |
| United States | 1275.1.01018 Boehringer Ingelheim Investigational Site | Pearland | Texas |
| United States | 1275.1.01047 Boehringer Ingelheim Investigational Site | Pell City | Alabama |
| United States | 1275.1.01051 Boehringer Ingelheim Investigational Site | Pembroke Pines | Florida |
| United States | 1275.1.01019 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania |
| United States | 1275.1.01079 Boehringer Ingelheim Investigational Site | Port Orange | Florida |
| United States | 1275.1.01085 Boehringer Ingelheim Investigational Site | Rochester | Michigan |
| United States | 1275.1.01096 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1275.1.01113 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1275.1.01120 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1275.1.01071 Boehringer Ingelheim Investigational Site | San Dimas | California |
| United States | 1275.1.01076 Boehringer Ingelheim Investigational Site | Savannah | Georgia |
| United States | 1275.1.01072 Boehringer Ingelheim Investigational Site | Scottdale | Pennsylvania |
| United States | 1275.1.01118 Boehringer Ingelheim Investigational Site | Selah | Washington |
| United States | 1275.1.01087 Boehringer Ingelheim Investigational Site | Shoreline | Washington |
| United States | 1275.1.01003 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana |
| United States | 1275.1.01091 Boehringer Ingelheim Investigational Site | South Chesterfield | Virginia |
| United States | 1275.1.01035 Boehringer Ingelheim Investigational Site | Southfield | Michigan |
| United States | 1275.1.01119 Boehringer Ingelheim Investigational Site | Spokane | Washington |
| United States | 1275.1.01105 Boehringer Ingelheim Investigational Site | Spring | Texas |
| United States | 1275.1.01069 Boehringer Ingelheim Investigational Site | Spring Hill | Tennessee |
| United States | 1275.1.01023 Boehringer Ingelheim Investigational Site | St. Louis | Missouri |
| United States | 1275.1.01027 Boehringer Ingelheim Investigational Site | St. Louis | Missouri |
| United States | 1275.1.01117 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida |
| United States | 1275.1.01064 Boehringer Ingelheim Investigational Site | Tempe | Arizona |
| United States | 1275.1.01088 Boehringer Ingelheim Investigational Site | Tipton | Pennsylvania |
| United States | 1275.1.01044 Boehringer Ingelheim Investigational Site | Tustin | California |
| United States | 1275.1.01014 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania |
| United States | 1275.1.01060 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania |
| United States | 1275.1.01037 Boehringer Ingelheim Investigational Site | Waco | Texas |
| United States | 1275.1.01075 Boehringer Ingelheim Investigational Site | Wadsworth | Ohio |
| United States | 1275.1.01022 Boehringer Ingelheim Investigational Site | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim | Eli Lilly and Company |
United States, Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Denmark, Estonia, Hungary, Italy, Lebanon, Malaysia, Mexico, Peru, Philippines, Poland, Romania, Russian Federation, Spain, Sweden, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients | Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage. | Baseline and 24 weeks | No |
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients | Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage. | Baseline and 24 weeks | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients | Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients. | Baseline and 24 Weeks | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients | Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients. | Baseline and 24 Weeks | No |
| Secondary | Change From Baseline in Body Weight for Metformin Background Patients | Change from baseline in body weight for Metformin Background patients. | Baseline and 24 Weeks | No |
| Secondary | Change From Baseline in Body Weight for Treatment Naive Patients | Change from baseline in body weight for Treatment Naive patients. | Baseline and 24 Weeks | No |
| Secondary | Occurrence of Treat to Target Efficacy Response for Metformin Background Patients | Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline. | 24 Weeks | No |
| Secondary | Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients | Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline. | 24 Weeks | No |
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