Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide When Used in Combination With Metformin Compared With Metformin Plus Sitagliptin, Metformin Plus Glimepiride, and Metformin Plus Placebo in Subjects With Type 2 Diabetes Mellitus
| Verified date | August 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 if albiglutide is safe and effective in the treatment of type 2 diabetes.
| Status | Completed |
| Enrollment | 1049 |
| Est. completion date | March 2013 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - type 2 diabetes - BMI 20-45kg/m2 inclusive Exclusion Criteria: - females who are pregnant, lactating or <6 weeks post-partum - current symptomatic heart failure (NYHA Class III or IV) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Albania | GSK Investigational Site | Alabaster | |
| Germany | GSK Investigational Site | Bad Lauterberg | Niedersachsen |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Kelkheim | Hessen |
| Germany | GSK Investigational Site | Mainz | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Rotenburg | Hessen |
| Germany | GSK Investigational Site | Villingen-Schwenningen | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Witten | Nordrhein-Westfalen |
| Hong Kong | GSK Investigational Site | Kwun Tong, Kowloon | |
| Hong Kong | GSK Investigational Site | Shatin | |
| Hong Kong | GSK Investigational Site | Tai Po, | |
| Mexico | GSK Investigational Site | Cuernavaca | Morelos |
| Mexico | GSK Investigational Site | Distrito Federal | |
| Mexico | GSK Investigational Site | Durango | |
| Mexico | GSK Investigational Site | Guadalajara | |
| Mexico | GSK Investigational Site | Guadalajara | |
| Mexico | GSK Investigational Site | Guadalajara | Jalisco |
| Mexico | GSK Investigational Site | Merida | Yucatán |
| Mexico | GSK Investigational Site | Mexico City | |
| Mexico | GSK Investigational Site | Mexico City | |
| Mexico | GSK Investigational Site | Morelia | Michoacán |
| Mexico | GSK Investigational Site | Nezahualcoyotl | |
| Mexico | GSK Investigational Site | Pachuca | Hidalgo |
| Mexico | GSK Investigational Site | Puebla | |
| Mexico | GSK Investigational Site | Tijuana | Baja California Norte |
| Mexico | GSK Investigational Site | Torreon | Coahuila |
| Mexico | GSK Investigational Site | Zapopan | Jalisco |
| Peru | GSK Investigational Site | Callao | Lima |
| Peru | GSK Investigational Site | Ica | |
| Peru | GSK Investigational Site | Lima | |
| Peru | GSK Investigational Site | Lima | |
| Peru | GSK Investigational Site | Piura | |
| Philippines | GSK Investigational Site | Cebu City | |
| Philippines | GSK Investigational Site | Quezon City | |
| Philippines | GSK Investigational Site | Quezon City | |
| Philippines | GSK Investigational Site | San Juan | |
| Philippines | GSK Investigational Site | Taytay Rizal | |
| Russian Federation | GSK Investigational Site | Arkhangelsk | |
| Russian Federation | GSK Investigational Site | Irkutsk | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Nizhniy Novgorod | |
| Russian Federation | GSK Investigational Site | Saratov | |
| Russian Federation | GSK Investigational Site | Smolensk | |
| Russian Federation | GSK Investigational Site | Yaroslavl | |
| South Africa | GSK Investigational Site | Boksburg North | Gauteng |
| South Africa | GSK Investigational Site | Cape Town | |
| South Africa | GSK Investigational Site | Durban | KwaZulu- Natal |
| South Africa | GSK Investigational Site | Johannesburg | Gauteng |
| South Africa | GSK Investigational Site | Kempton Park | |
| South Africa | GSK Investigational Site | Lenasia | Gauteng |
| South Africa | GSK Investigational Site | Parktown | Gauteng |
| South Africa | GSK Investigational Site | Parow | |
| South Africa | GSK Investigational Site | Port Elizabeth | Eastern Cape |
| South Africa | GSK Investigational Site | Pretoria | Gauteng |
| South Africa | GSK Investigational Site | Somerset West | |
| South Africa | GSK Investigational Site | Soweto | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Sevilla | |
| 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 | Hull | |
| United Kingdom | GSK Investigational Site | Liverpool | |
| United Kingdom | GSK Investigational Site | Liverpool | Merseyside |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | Plymouth | Devon |
| 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 | Albuquerque | New Mexico |
| 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 | Aurora | Illinois |
| 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 | Blue Ridge | Georgia |
| United States | GSK Investigational Site | Bountiful | Utah |
| United States | GSK Investigational Site | Boynton Beach | Florida |
| United States | GSK Investigational Site | Boynton Beach | Florida |
| 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 | Cadillac | Michigan |
| 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 | Chino | California |
| 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 | 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 | Ohio |
| United States | GSK Investigational Site | Columbus | Georgia |
| 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 | 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 | 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 | 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 | El Paso | Texas |
| United States | GSK Investigational Site | Elizabeth | New Jersey |
| United States | GSK Investigational Site | Escondido | California |
| 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 | Gainesville | Florida |
| United States | GSK Investigational Site | Germantown | Tennessee |
| United States | GSK Investigational Site | Gilbert | Arizona |
| United States | GSK Investigational Site | Grand Forks | North Dakota |
| 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 | 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 | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Hueytown | Alabama |
| United States | GSK Investigational Site | Huntersville | North Carolina |
| 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 | 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 Porte | Indiana |
| United States | GSK Investigational Site | LaJolla | California |
| 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 | 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 | Lexington | Kentucky |
| United States | GSK Investigational Site | Lincoln | Nebraska |
| United States | GSK Investigational Site | Loma Linda | California |
| 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 | Madisonville | Kentucky |
| United States | GSK Investigational Site | Manassas | Virginia |
| United States | GSK Investigational Site | Manning | South Carolina |
| 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 | 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 | 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 | Muncie | Indiana |
| 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 Brunswick | New Jersey |
| 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 | 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 | 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 | 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 | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Plantation | Florida |
| United States | GSK Investigational Site | Ponte Vedra Beach | Florida |
| United States | GSK Investigational Site | Poway | California |
| United States | GSK Investigational Site | Richland | Washington |
| 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 | 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 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 | Santa Ana | California |
| United States | GSK Investigational Site | Satna Monica | California |
| 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 | Spring Valley | California |
| United States | GSK Investigational Site | Springfield | Missouri |
| 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 | St. Petersburg | Florida |
| 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 | Syracuse | New York |
| United States | GSK Investigational Site | Tabor City | North Carolina |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Tarzana | California |
| United States | GSK Investigational Site | Taylors | South Carolina |
| United States | GSK Investigational Site | Temple | Texas |
| 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 | Trumbull | Connecticut |
| United States | GSK Investigational Site | Tucker | Georgia |
| United States | GSK Investigational Site | Tucson | Arizona |
| 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 | Tulsa | Oklahoma |
| United States | GSK Investigational Site | Tuscaloosa | Alabama |
| United States | GSK Investigational Site | Uniontown | Pennsylvania |
| United States | GSK Investigational Site | Victorville | California |
| United States | GSK Investigational Site | Virgina Beach | Virginia |
| United States | GSK Investigational Site | Vista | 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 Palm Beach | Florida |
| United States | GSK Investigational Site | West Plains | Missouri |
| United States | GSK Investigational Site | West Valley City | Utah |
| United States | GSK Investigational Site | Wichita | Kansas |
| United States | GSK Investigational Site | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Albania, Germany, Hong Kong, Mexico, Peru, Philippines, Russian Federation, South Africa, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 104 | 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 104 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region. Difference of least squares means (albiglutide - placebo, albiglutide - sitagliptin, albiglutide - glimepiride) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline 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. | Baseline and Week 104 | No |
| Secondary | Change From Baseline in HbA1c at Week 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 Week 156 | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 104 | 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 FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region. | Baseline and Week 104 | No |
| Secondary | Change From Baseline in FPG at Week 156 | 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. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed FPG values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. | 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 104 | The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of <6.5%, <7%, and <7.5% at Week 52) were assessed. | Week 104 | 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%, <7%, and <7.5% at Week 156) were assessed. | Week 156 | No |
| Secondary | Time to Hyperglycemia Rescue | Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue.The conditions for hyperglycemic 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 Body Weight at Week 104 | 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 + Baseline HbA1c category + prior myocardial infarction history + age category + region. | Baseline and Week 104 | 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. This analysis used observed body weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. | Baseline and Week 156 | No |
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N/A | |
| Completed |
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Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
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Phase 1 | |
| Completed |
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Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
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N/A | |
| Recruiting |
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Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
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N/A | |
| Completed |
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A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
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Phase 1 | |
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Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
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N/A | |
| Completed |
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Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
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Phase 4 | |
| Completed |
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Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
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N/A | |
| Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
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| Completed |
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An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
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| Completed |
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Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
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Phase 4 | |
| Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
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| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
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N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
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Phase 2 |