Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Pioglitazone With or Without Metformin in Subjects With Type 2 Diabetes Mellitus
| Verified date | May 2014 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine the safety, tolerability and efficacy of albiglutide in the treatment of type 2 diabetes.
| Status | Completed |
| Enrollment | 310 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - type 2 diabetes - BMI 20-45kg/m2 Exclusion Criteria: - NYHA Class II to IV heart failure - females who are pregnant, lactating, or less than 6 weeks post-partum |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | GSK Investigational Site | Aurangabad | |
| India | GSK Investigational Site | Pune | |
| Korea, Republic of | GSK Investigational Site | Seongnam-si | |
| Korea, Republic of | GSK Investigational Site | Suwon, Kyonggi-do | |
| Peru | GSK Investigational Site | Arequipa | |
| Peru | GSK Investigational Site | El Agustino | Lima |
| Peru | GSK Investigational Site | Huacho | Lima |
| Peru | GSK Investigational Site | Lima | |
| Peru | GSK Investigational Site | Trujillo | |
| South Africa | GSK Investigational Site | Kempton Park | |
| South Africa | GSK Investigational Site | Phoenix | KwaZulu- Natal |
| South Africa | GSK Investigational Site | Port Elizabeth | Eastern Cape |
| South Africa | GSK Investigational Site | Somerset West | |
| United Kingdom | GSK Investigational Site | Blackpool | Lancashire |
| United Kingdom | GSK Investigational Site | Canterbury | Kent |
| United Kingdom | GSK Investigational Site | Coventry | West Midlands |
| United Kingdom | GSK Investigational Site | Glasgow | |
| United Kingdom | GSK Investigational Site | Liverpool | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | Port Glasgow | Renfrewshire |
| United Kingdom | GSK Investigational Site | Sunbury-on-Thames | Middlesex |
| United States | GSK Investigational Site | Akron | Ohio |
| United States | GSK Investigational Site | Alabaster | Alabama |
| United States | GSK Investigational Site | Arkansas City | Kansas |
| United States | GSK Investigational Site | Arlington | Texas |
| United States | GSK Investigational Site | Arvada | Colorado |
| United States | GSK Investigational Site | Asheboro | North Carolina |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Ashland | Oregon |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Avon | Indiana |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Bay City | Michigan |
| United States | GSK Investigational Site | Bedford | Texas |
| United States | GSK Investigational Site | Bensalem | Pennsylvania |
| United States | GSK Investigational Site | Benzonia | Michigan |
| United States | GSK Investigational Site | Berlin | New Jersey |
| United States | GSK Investigational Site | Billings | Montana |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Bloomfield Hills | Michigan |
| United States | GSK Investigational Site | Blue Ridge | Georgia |
| United States | GSK Investigational Site | Boise | Idaho |
| United States | GSK Investigational Site | Bountiful | Utah |
| United States | GSK Investigational Site | Bristol | Tennessee |
| United States | GSK Investigational Site | Broken Bow | Nebraska |
| United States | GSK Investigational Site | Buena Park | California |
| United States | GSK Investigational Site | Bull Shoals | Arkansas |
| United States | GSK Investigational Site | Burke | Virginia |
| United States | GSK Investigational Site | Burlington | North Carolina |
| United States | GSK Investigational Site | Butte | Montana |
| United States | GSK Investigational Site | Calabash | North Carolina |
| United States | GSK Investigational Site | Canal Fulton | Ohio |
| United States | GSK Investigational Site | Carlisle | Pennsylvania |
| United States | GSK Investigational Site | Carmichael | California |
| United States | GSK Investigational Site | Chadbourn | North Carolina |
| United States | GSK Investigational Site | Chandler | Arizona |
| United States | GSK Investigational Site | Chattanooga | Tennessee |
| United States | GSK Investigational Site | Chesterfield | Missouri |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chula Vista | California |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Clarksville | Tennessee |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Cleburne | Texas |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Cocoa | Florida |
| United States | GSK Investigational Site | Columbia | Tennessee |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Columbus | Georgia |
| United States | GSK Investigational Site | Corpus Christi | Texas |
| United States | GSK Investigational Site | Corpus Christi | Texas |
| United States | GSK Investigational Site | Council Bluffs | Iowa |
| United States | GSK Investigational Site | Covington | Louisiana |
| United States | GSK Investigational Site | Crescent Springs | Kentucky |
| United States | GSK Investigational Site | Crossville | Tennessee |
| United States | GSK Investigational Site | Cumberland | Rhode Island |
| United States | GSK Investigational Site | Cutler Bay | Florida |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dayton | Ohio |
| United States | GSK Investigational Site | Dayton | Ohio |
| United States | GSK Investigational Site | Dearborn | Michigan |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | Deer Park | Texas |
| United States | GSK Investigational Site | Deerfield Beach | Florida |
| United States | GSK Investigational Site | Delray Beach | Florida |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Des Moines | Iowa |
| United States | GSK Investigational Site | Dothan | Alabama |
| United States | GSK Investigational Site | Downington | Pennsylvania |
| United States | GSK Investigational Site | Dubuque | Iowa |
| United States | GSK Investigational Site | Durham | North Carolina |
| United States | GSK Investigational Site | East Providence | Rhode Island |
| United States | GSK Investigational Site | Edgewater | Florida |
| United States | GSK Investigational Site | El Paso | Texas |
| United States | GSK Investigational Site | Elizabeth | New Jersey |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Evergreen Park | Illinois |
| United States | GSK Investigational Site | Fayetteville | North Carolina |
| United States | GSK Investigational Site | Fayetteville | Tennessee |
| United States | GSK Investigational Site | Feasterville | Pennsylvania |
| United States | GSK Investigational Site | Federal Way | Washington |
| United States | GSK Investigational Site | Fishers | Indiana |
| United States | GSK Investigational Site | Foothill Ranch | California |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Fort Worth | Texas |
| United States | GSK Investigational Site | Fort Worth | Texas |
| United States | GSK Investigational Site | Fountain Valley | California |
| United States | GSK Investigational Site | Fresno | California |
| United States | GSK Investigational Site | Fullerton | California |
| United States | GSK Investigational Site | Gainesville | Florida |
| United States | GSK Investigational Site | Germantown | Tennessee |
| United States | GSK Investigational Site | Gilbert | Arizona |
| United States | GSK Investigational Site | Great Falls | Montana |
| United States | GSK Investigational Site | Green Valley | Arizona |
| United States | GSK Investigational Site | Greensboro | North Carolina |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Greer | South Carolina |
| United States | GSK Investigational Site | Gulfport | Mississippi |
| United States | GSK Investigational Site | Haddon Heights | New Jersey |
| United States | GSK Investigational Site | Hainesport | New Jersey |
| United States | GSK Investigational Site | Hallandale Beach | Florida |
| United States | GSK Investigational Site | Hampton | Virginia |
| United States | GSK Investigational Site | Harrisburg | Pennsylvania |
| United States | GSK Investigational Site | Harrisburg | Arkansas |
| United States | GSK Investigational Site | Haverhill | Massachusetts |
| United States | GSK Investigational Site | Hialeah | Florida |
| United States | GSK Investigational Site | Hialeah | Florida |
| United States | GSK Investigational Site | Hickory | North Carolina |
| United States | GSK Investigational Site | Hollywood | Florida |
| United States | GSK Investigational Site | Honolulu | Hawaii |
| United States | GSK Investigational Site | Honolulu | Hawaii |
| United States | GSK Investigational Site | Hot Springs | Arkansas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Hueytown | Alabama |
| United States | GSK Investigational Site | Huntington Beach | California |
| United States | GSK Investigational Site | Huntington Beach | California |
| United States | GSK Investigational Site | Hurst | Texas |
| United States | GSK Investigational Site | Hyattsville | Maryland |
| United States | GSK Investigational Site | Idaho Falls | Idaho |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Indio | California |
| United States | GSK Investigational Site | Interlochen | Michigan |
| United States | GSK Investigational Site | Iowa City | Iowa |
| United States | GSK Investigational Site | Irvine | California |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jefferson City | Missouri |
| United States | GSK Investigational Site | Johnson City | Tennessee |
| United States | GSK Investigational Site | Jonesboro | Arkansas |
| United States | GSK Investigational Site | Kalamazoo | Michigan |
| United States | GSK Investigational Site | Kalamazoo | Michigan |
| United States | GSK Investigational Site | Kansas City | Missouri |
| United States | GSK Investigational Site | Kansas City | Missouri |
| United States | GSK Investigational Site | Katy | Texas |
| United States | GSK Investigational Site | Kettering | Ohio |
| United States | GSK Investigational Site | La Grange | Illinois |
| United States | GSK Investigational Site | La Jolla | California |
| United States | GSK Investigational Site | La Porte | Indiana |
| United States | GSK Investigational Site | Lafayette | Indiana |
| United States | GSK Investigational Site | Lake Charles | Louisiana |
| United States | GSK Investigational Site | Lake Jackson | Texas |
| United States | GSK Investigational Site | Lakewood | California |
| United States | GSK Investigational Site | Landsdale | Pennsylvania |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Lauderdale Lakes | Florida |
| United States | GSK Investigational Site | Lenoir | North Carolina |
| United States | GSK Investigational Site | Lewisburg | West Virginia |
| United States | GSK Investigational Site | Lewisville | Texas |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Lincoln | Nebraska |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Los Alamitos | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Manassas | Virginia |
| United States | GSK Investigational Site | Marianna | Florida |
| United States | GSK Investigational Site | Mason | Ohio |
| United States | GSK Investigational Site | Maumee | Ohio |
| United States | GSK Investigational Site | McKenzie | Tennessee |
| United States | GSK Investigational Site | Melrose Park | Pennsylvania |
| United States | GSK Investigational Site | Memphis | Tennessee |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Middletown | Delaware |
| United States | GSK Investigational Site | Midland | Texas |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Mint HIll | North Carolina |
| United States | GSK Investigational Site | Mission | Kansas |
| United States | GSK Investigational Site | Mission Viejo | California |
| United States | GSK Investigational Site | Mobile | Alabama |
| United States | GSK Investigational Site | Morehead City | North Carolina |
| United States | GSK Investigational Site | Murrells Inlet | South Carolina |
| United States | GSK Investigational Site | Naperville | Illinois |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | New Britain | Connecticut |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newton | Kansas |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | North Massapequa | New York |
| United States | GSK Investigational Site | North Miami | Florida |
| United States | GSK Investigational Site | North Myrtle Beach | South Carolina |
| United States | GSK Investigational Site | North Richland Hills | Texas |
| United States | GSK Investigational Site | Northridge | California |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Odessa | Texas |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Orangeburg | South Carolina |
| United States | GSK Investigational Site | Orem | Utah |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Ormond Beach | Florida |
| United States | GSK Investigational Site | Overland Park | Kansas |
| United States | GSK Investigational Site | Oviedo | Florida |
| United States | GSK Investigational Site | Oxon Hill | Maryland |
| United States | GSK Investigational Site | Paducah | Kentucky |
| United States | GSK Investigational Site | Palm Desert | California |
| United States | GSK Investigational Site | Palm Springs | California |
| United States | GSK Investigational Site | Panama City | Florida |
| United States | GSK Investigational Site | Pasadena | California |
| United States | GSK Investigational Site | Pembroke Pines | Florida |
| United States | GSK Investigational Site | Pembroke Pines | Florida |
| United States | GSK Investigational Site | Peoria | Arizona |
| United States | GSK Investigational Site | Peoria | Illinois |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Picayune | Mississippi |
| United States | GSK Investigational Site | Plantation | Florida |
| United States | GSK Investigational Site | Ponte Verda | Florida |
| United States | GSK Investigational Site | Poway | California |
| United States | GSK Investigational Site | Renton | Washington |
| United States | GSK Investigational Site | Richland | Washington |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Riverside | California |
| United States | GSK Investigational Site | Rolling Fork | Mississippi |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | Satna Monica | California |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | Schertz | Texas |
| United States | GSK Investigational Site | Searcy | Arkansas |
| United States | GSK Investigational Site | Selah | Washington |
| United States | GSK Investigational Site | Shelby | North Carolina |
| United States | GSK Investigational Site | Shreveport | Louisiana |
| United States | GSK Investigational Site | Shreveport | Louisiana |
| United States | GSK Investigational Site | Simpsonville | South Carolina |
| United States | GSK Investigational Site | Snellville | Georgia |
| United States | GSK Investigational Site | South Bend | Indiana |
| United States | GSK Investigational Site | South Burlington | Vermont |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | St Clair Shores | Michigan |
| United States | GSK Investigational Site | St. Cloud | Florida |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Stone Mountain | Georgia |
| United States | GSK Investigational Site | Stratford | New Jersey |
| United States | GSK Investigational Site | Suffolk | Virginia |
| United States | GSK Investigational Site | Sugar Land | Texas |
| United States | GSK Investigational Site | Sugarland | Texas |
| United States | GSK Investigational Site | Tabor City | North Carolina |
| United States | GSK Investigational Site | Tacoma | Washington |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Tarzana | California |
| United States | GSK Investigational Site | Thornville | Ohio |
| United States | GSK Investigational Site | Tipton | Pennsylvania |
| United States | GSK Investigational Site | Topeka | Kansas |
| United States | GSK Investigational Site | Torrance | California |
| United States | GSK Investigational Site | Trumbull | Connecticut |
| United States | GSK Investigational Site | Tucker | Georgia |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tullahoma | Tennessee |
| United States | GSK Investigational Site | Tulsa | Oklahoma |
| United States | GSK Investigational Site | Tulsa | Oklahoma |
| United States | GSK Investigational Site | Tuscaloosa | Alabama |
| United States | GSK Investigational Site | Tustin | California |
| United States | GSK Investigational Site | Uniontown | Pennsylvania |
| United States | GSK Investigational Site | Victorville | California |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Waterbury | Connecticut |
| United States | GSK Investigational Site | Waterloo | Iowa |
| United States | GSK Investigational Site | Weber City | Virginia |
| United States | GSK Investigational Site | West Hills | California |
| United States | GSK Investigational Site | West Jordan | Utah |
| United States | GSK Investigational Site | West Plains | Missouri |
| United States | GSK Investigational Site | West Valley City | Utah |
| United States | GSK Investigational Site | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, India, Korea, Republic of, Peru, South Africa, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. The last observation carried forward (LOCF) method was used to impute missing post-BL HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values. One Intent-to-Treat (ITT) participant (par.) had all post-BL HbA1c measurements occur after hyperglycemic rescue. This par. is included in the ITT Population counts but did not contribute to this analysis. | Baseline and Week 52 | No |
| Secondary | Change From Baseline in HbA1c at Weeks 104 and 156 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. | Baseline and Weeks 104 and 156 | No |
| Secondary | Time to Hyperglycemia Rescue | Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG >=280 milligrams/deciliter (mg/dL) between >=Week 2 and | From the start of study medication until the end of the treatment (up to Week 156) |
No |
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy. | Baseline and Week 52 | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 | The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline FPG minus the Baseline FPG. | Baseline and Week 156 | No |
| Secondary | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52 | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 52) were assessed. | Week 52 | No |
| Secondary | Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156 | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <6.5%, and <7.0% at Week 156) were assessed. | Week 156 | No |
| Secondary | Change From Baseline in Body Weight at Week 52 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + prior myocardial infarction history + age category + region + current antidiabetic therapy. | Baseline and Week 52 | No |
| Secondary | Change From Baseline in Body Weight at Week 156 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. | Baseline and Week 156 | No |
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