A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.

January 16, 2017 updated by: GlaxoSmithKline

A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment

This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Intervention / Treatment

Detailed Description

This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.

Study Type

Interventional

Enrollment (Actual)

507

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Australian Capital Territory
  - Garran, Australian Capital Territory, Australia, 2606
    - GSK Investigational Site
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - GSK Investigational Site
- Queensland
  - Auchenflower, Queensland, Australia, 4066
    - GSK Investigational Site
  - Caboolture, Queensland, Australia, 4510
    - GSK Investigational Site
  - Herston, Queensland, Australia, 4029
    - GSK Investigational Site
  - Kippa Ring, Queensland, Australia, 4021
    - GSK Investigational Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - GSK Investigational Site
  - Clayton, Victoria, Australia, 3168
    - GSK Investigational Site
  - Heidelberg, Victoria, Australia, 3081
    - GSK Investigational Site
  - Melbourne, Victoria, Australia, 3135
    - GSK Investigational Site
  - Parkville, Victoria, Australia, 3050
    - GSK Investigational Site
- Western Australia
  - Fremantle, Western Australia, Australia, 6160
    - GSK Investigational Site
Brazil
- - Brasília, Brazil, 71625-009
    - GSK Investigational Site
  - Mogi das Cruzes, Brazil, 08780 - 090
    - GSK Investigational Site
  - São Paulo, Brazil, 05302-001
    - GSK Investigational Site
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-170
    - GSK Investigational Site
Colombia
- - Barrangquilla, Colombia
    - GSK Investigational Site
  - Bogota, Colombia, 110221
    - GSK Investigational Site
  - Floridablanca-Santander, Colombia
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10115
    - GSK Investigational Site
- Hessen
  - Bad Nauheim, Hessen, Germany, 61231
    - GSK Investigational Site
- Niedersachsen
  - Bad Lauterberg, Niedersachsen, Germany, 37431
    - GSK Investigational Site
- Rheinland-Pfalz
  - Mainz, Rheinland-Pfalz, Germany, 55116
    - GSK Investigational Site
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - GSK Investigational Site
India
- - Ahmedabad, India, 380015
    - GSK Investigational Site
  - Bangalore, India, 560 010
    - GSK Investigational Site
  - Bangalore, India, 560 054
    - GSK Investigational Site
  - Bangalore, India, 560043
    - GSK Investigational Site
  - Bangalore, India, 560052
    - GSK Investigational Site
  - Bangalore, India, 560078
    - GSK Investigational Site
  - Belgaum, India, 590001
    - GSK Investigational Site
  - Belgaum,, India, 590010
    - GSK Investigational Site
  - Chennai, India, 600013
    - GSK Investigational Site
  - Lucknow, India, 226005
    - GSK Investigational Site
  - Manipal, India, 576104
    - GSK Investigational Site
  - Mumbai, India, 400 008
    - GSK Investigational Site
  - Nasik, India, 422013
    - GSK Investigational Site
Israel
- - Ashkelon, Israel, 78278
    - GSK Investigational Site
  - Beer-Sheva, Israel, 84101
    - GSK Investigational Site
  - Haifa, Israel, 31096
    - GSK Investigational Site
  - Haifa, Israel, 35251
    - GSK Investigational Site
  - Holon, Israel, 58100
    - GSK Investigational Site
  - Kfar Saba, Israel, 44281
    - GSK Investigational Site
  - Safed, Israel, 13110
    - GSK Investigational Site
Korea, Republic of
- - Seongnam-si, Korea, Republic of, 463712
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 137-701
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-720
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 136-705
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 139-872
    - GSK Investigational Site
  - Suwon, Kyonggi-do, Korea, Republic of, 443-721
    - GSK Investigational Site
Peru
- - Arequipa, Peru, 54
    - GSK Investigational Site
  - Ica, Peru, 11
    - GSK Investigational Site
  - Lima, Peru, Lima 1
    - GSK Investigational Site
  - Lima, Peru, 01
    - GSK Investigational Site
  - Lima, Peru, 17
    - GSK Investigational Site
  - Piura, Peru
    - GSK Investigational Site
  - Trujillo, Peru
    - GSK Investigational Site
- Lima
  - Callao, Lima, Peru, Callao 2
    - GSK Investigational Site
Philippines
- - Cebu City, Philippines, 6000
    - GSK Investigational Site
  - Iloilo City, Philippines, 5000
    - GSK Investigational Site
  - Makati City, Philippines, 1218
    - GSK Investigational Site
  - Pasay, Philippines, 1300
    - GSK Investigational Site
  - Tagbilaran City, Philippines, 6300
    - GSK Investigational Site
Russian Federation
- - Nizhniy Novgorod, Russian Federation, 603126
    - GSK Investigational Site
  - Saratov, Russian Federation, 410030
    - GSK Investigational Site
  - St'Petersburg, Russian Federation, 194156
    - GSK Investigational Site
  - Yaroslavl, Russian Federation, 150062
    - GSK Investigational Site
South Africa
- - Houghton, South Africa, 2198
    - GSK Investigational Site
  - Pretoria, South Africa, 0002
    - GSK Investigational Site
  - Somerset West, South Africa, 07129
    - GSK Investigational Site
  - Tygerberg, South Africa, 7505
    - GSK Investigational Site
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6014
    - GSK Investigational Site
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2013
    - GSK Investigational Site
  - Johannesburg, Gauteng, South Africa, 2193
    - GSK Investigational Site
  - Lenasia, Gauteng, South Africa, 1827
    - GSK Investigational Site
  - Pretoria, Gauteng, South Africa, 0084
    - GSK Investigational Site
- KwaZulu- Natal
  - Durban, KwaZulu- Natal, South Africa, 4092
    - GSK Investigational Site
  - Phoenix, KwaZulu- Natal, South Africa, 4068
    - GSK Investigational Site
Spain
- - Alicante, Spain, 03114
    - GSK Investigational Site
  - La Coruña, Spain, 15006
    - GSK Investigational Site
  - Málaga, Spain, 29010
    - GSK Investigational Site
  - Palma de Mallorca, Spain, 07014
    - GSK Investigational Site
  - Santiago de Compostela, Spain, 15706
    - GSK Investigational Site
  - Sevilla, Spain, 41003
    - GSK Investigational Site
  - Torrevieja (Alicante), Spain, 03186
    - GSK Investigational Site
Taiwan
- - Kaohsiung, Taiwan, 833
    - GSK Investigational Site
  - Taichung, Taiwan, 404
    - GSK Investigational Site
  - Tainan, Taiwan, 71044
    - GSK Investigational Site
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - GSK Investigational Site
  - Hertfordshire, United Kingdom
    - GSK Investigational Site
  - Hull, United Kingdom, HU3 2RW
    - GSK Investigational Site
  - Liverpool, United Kingdom, L9 7AL
    - GSK Investigational Site
  - Livingston, United Kingdom, EH54 6PP
    - GSK Investigational Site
  - London, United Kingdom, SE1 9NH
    - GSK Investigational Site
  - Plymouth, United Kingdom, PL6 8BX
    - GSK Investigational Site
  - Swansea, United Kingdom, SA6 6NL
    - GSK Investigational Site
- West Midlands
  - Coventry, West Midlands, United Kingdom, CV2 2DX
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - GSK Investigational Site
  - Gulf Shores, Alabama, United States, 36542
    - GSK Investigational Site
  - Huntsville, Alabama, United States, 35801
    - GSK Investigational Site
  - Toney, Alabama, United States, 35773
    - GSK Investigational Site
- Arizona
  - Phoenix, Arizona, United States, 85028
    - GSK Investigational Site
- California
  - Fresno, California, United States, 93720
    - GSK Investigational Site
  - Huntington Beach, California, United States, 92648
    - GSK Investigational Site
  - Los Angeles, California, United States, 90073
    - GSK Investigational Site
  - Los Angeles, California, United States, 90017
    - GSK Investigational Site
  - Los Angeles, California, United States, 90022
    - GSK Investigational Site
  - Los Gatos, California, United States, 95032
    - GSK Investigational Site
  - Orange, California, United States, 92868
    - GSK Investigational Site
  - San Diego, California, United States, 92120
    - GSK Investigational Site
  - San Diego, California, United States, 92161
    - GSK Investigational Site
  - San Dimas, California, United States, 91773
    - GSK Investigational Site
  - Tarzana, California, United States, 91356
    - GSK Investigational Site
  - West Hills, California, United States, 91307
    - GSK Investigational Site
  - Whittier, California, United States, 90602
    - GSK Investigational Site
  - Whittier, California, United States, 90603
    - GSK Investigational Site
- Florida
  - Doral, Florida, United States, 33172
    - GSK Investigational Site
  - Hollywood, Florida, United States, 33021
    - GSK Investigational Site
  - Jacksonville, Florida, United States, 32205
    - GSK Investigational Site
  - Miami, Florida, United States, 33136
    - GSK Investigational Site
  - Miami Beach, Florida, United States, 33141
    - GSK Investigational Site
  - New Port Richey, Florida, United States, 34653
    - GSK Investigational Site
  - Pembroke Pines, Florida, United States, 33028
    - GSK Investigational Site
  - Plantation, Florida, United States, 33322
    - GSK Investigational Site
  - Tampa, Florida, United States, 33613
    - GSK Investigational Site
  - Winter Park, Florida, United States, 32789
    - GSK Investigational Site
  - Winter Park, Florida, United States, 32792
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - GSK Investigational Site
  - Atlanta, Georgia, United States, 30312
    - GSK Investigational Site
  - Augusta, Georgia, United States, 30909
    - GSK Investigational Site
  - Blue Ridge, Georgia, United States, 30513
    - GSK Investigational Site
  - Decatur, Georgia, United States, 30032
    - GSK Investigational Site
  - Roswell, Georgia, United States, 30076
    - GSK Investigational Site
  - Stone Mountain, Georgia, United States, 30088
    - GSK Investigational Site
- Indiana
  - Valparaiso, Indiana, United States, 46383
    - GSK Investigational Site
- Iowa
  - Des Moines, Iowa, United States, 50314
    - GSK Investigational Site
- Kansas
  - Mission, Kansas, United States, 66202
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40504
    - GSK Investigational Site
  - Paducah, Kentucky, United States, 42003
    - GSK Investigational Site
- Louisiana
  - Alexandria, Louisiana, United States, 71301
    - GSK Investigational Site
- Maine
  - Bangor, Maine, United States, 04401
    - GSK Investigational Site
- Maryland
  - Hyattsville, Maryland, United States, 20782
    - GSK Investigational Site
- Massachusetts
  - Springfield, Massachusetts, United States, 01107
    - GSK Investigational Site
- Michigan
  - Dearborn, Michigan, United States, 48124
    - GSK Investigational Site
  - Detroit, Michigan, United States, 48235
    - GSK Investigational Site
  - Flint, Michigan, United States, 48504
    - GSK Investigational Site
  - St Clair Shores, Michigan, United States, 48081
    - GSK Investigational Site
  - Taylor, Michigan, United States, 48180
    - GSK Investigational Site
- Missouri
  - Kansas City, Missouri, United States, 64111
    - GSK Investigational Site
  - Kansas City, Missouri, United States, 64128
    - GSK Investigational Site
  - Springfield, Missouri, United States, 65807
    - GSK Investigational Site
- Nebraska
  - Omaha, Nebraska, United States, 68131
    - GSK Investigational Site
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - GSK Investigational Site
  - Las Vegas, Nevada, United States, 89103
    - GSK Investigational Site
- New York
  - North Massapequa, New York, United States, 11758
    - GSK Investigational Site
  - Staten Island, New York, United States, 10301
    - GSK Investigational Site
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - GSK Investigational Site
  - Hurst, North Carolina, United States, 76054
    - GSK Investigational Site
  - Shelby, North Carolina, United States, 28150
    - GSK Investigational Site
  - Tabor City, North Carolina, United States, 28463
    - GSK Investigational Site
  - Wilmington, North Carolina, United States, 28401
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - GSK Investigational Site
  - Cleveland, Ohio, United States, 44195
    - GSK Investigational Site
  - Gallipolis, Ohio, United States, 45631
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - GSK Investigational Site
- Oregon
  - Medford, Oregon, United States, 97501
    - GSK Investigational Site
- Pennsylvania
  - Altoona, Pennsylvania, United States, 16602
    - GSK Investigational Site
  - Downington, Pennsylvania, United States, 19335
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19146
    - GSK Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29412
    - GSK Investigational Site
  - Columbia, South Carolina, United States, 29204
    - GSK Investigational Site
  - Greer, South Carolina, United States, 29651
    - GSK Investigational Site
  - North Myrtle Beach, South Carolina, United States, 29582
    - GSK Investigational Site
  - Taylors, South Carolina, United States, 29687
    - GSK Investigational Site
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - GSK Investigational Site
  - Franklin, Tennessee, United States, 37067
    - GSK Investigational Site
  - Knoxville, Tennessee, United States, 37923
    - GSK Investigational Site
  - Tullahoma, Tennessee, United States, 37398
    - GSK Investigational Site
- Texas
  - Arlington, Texas, United States, 76011
    - GSK Investigational Site
  - Arlington, Texas, United States, 76014
    - GSK Investigational Site
  - Austin, Texas, United States, 78751
    - GSK Investigational Site
  - Austin, Texas, United States, 78758
    - GSK Investigational Site
  - Dallas, Texas, United States, 75224
    - GSK Investigational Site
  - Dallas, Texas, United States, 75231
    - GSK Investigational Site
  - Dallas, Texas, United States, 75251
    - GSK Investigational Site
  - Deer Park, Texas, United States, 77536
    - GSK Investigational Site
  - Fort Worth, Texas, United States, 76104
    - GSK Investigational Site
  - Grapevine, Texas, United States, 76051
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Houston, Texas, United States, 77027
    - GSK Investigational Site
  - Houston, Texas, United States, 77036
    - GSK Investigational Site
  - Houston, Texas, United States, 77070
    - GSK Investigational Site
  - Houston, Texas, United States, 77074
    - GSK Investigational Site
  - Houston, Texas, United States, 77081
    - GSK Investigational Site
  - Houston, Texas, United States, 77088
    - GSK Investigational Site
  - Houston, Texas, United States, 77099
    - GSK Investigational Site
  - Humble, Texas, United States, 77338
    - GSK Investigational Site
  - Hurst, Texas, United States, 76054
    - GSK Investigational Site
  - Irving, Texas, United States, 75039
    - GSK Investigational Site
  - Midland, Texas, United States, 79707
    - GSK Investigational Site
  - North Richland Hills, Texas, United States, 76180
    - GSK Investigational Site
  - Pearland, Texas, United States, 77584
    - GSK Investigational Site
  - Plano, Texas, United States, 75075
    - GSK Investigational Site
  - Richardson, Texas, United States, 75080
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78215
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78217
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78258
    - GSK Investigational Site
  - Schertz, Texas, United States, 78154
    - GSK Investigational Site
  - Sugarland, Texas, United States, 77479
    - GSK Investigational Site
  - Tomball, Texas, United States, 77375
    - GSK Investigational Site
- Utah
  - Bountiful, Utah, United States, 84010
    - GSK Investigational Site
- Vermont
  - South Burlington, Vermont, United States, 05403
    - GSK Investigational Site
- Virginia
  - Burke, Virginia, United States, 22015
    - GSK Investigational Site
  - Manassas, Virginia, United States, 20110
    - GSK Investigational Site
  - Norfolk, Virginia, United States, 23510
    - GSK Investigational Site
  - Salem, Virginia, United States, 24153
    - GSK Investigational Site
- Washington
  - Tacoma, Washington, United States, 98405
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
BMI >/=20 kg/m2 and </=45 kg/m2
Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
HbA1c between 7.0% and 10.0%, inclusive.

Exclusion Criteria:

History of cancer
History of treated diabetic gastroparesis
Current biliary disease or history of pancreatitis
History of significant gastrointestinal surgery
Recent clinically significant cardiovascular and/or cerebrovascular disease
History of human immunodeficiency virus infection
Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: albiglutide albiglutide weekly subcutaneous injection + sitagliptin matching placebo	Biological: albiglutide albiglutide weekly subcutaneous injection + sitagliptin matching placebo
Active Comparator: sitagliptin albiglutide matching placebo + sitagliptin	Drug: sitagliptin albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 Time Frame: Baseline; Week 26	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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 26 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with treatment group, region, history of prior myocardial infarction (yes versus no), and age category (<65 years versus >=65 years) as factors and Baseline HbA1c as a continuous covariate. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Baseline; Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF Time Frame: Baseline; Weeks 4, 8, 12, 16, and 20	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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.	Baseline; Weeks 4, 8, 12, 16, and 20
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases Time Frame: Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 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 Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the Baseline value. The Observed Cases (OC) method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.	Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 Time Frame: Baseline; Week 26	The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is define as the last non-missing value before the start of treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week. Based on ANCOVA: Change = treatment + Baseline FPG + renal impairment + prior myocardial infarction history + age category + region.	Baseline; Week 26
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF Time Frame: Baseline; Weeks 4, 8, 12, 16, 20, and 26	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 in FBG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.	Baseline; Weeks 4, 8, 12, 16, 20, and 26
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: OC Time Frame: Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, 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 defined as the last non-missing value prior to treatment. Change from Baseline in FBG was calculated as the post-Baseline value minus the Baseline value. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. Participants were analyzed in a particular treatment week if they had received at least one dose in that treatment week.	Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF Time Frame: Week 26	The number of participants who acheieved the HbA1c treatment goal (i.e., the number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Week 26
Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 26: LOCF Time Frame: Week 26	The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 26 were assessed. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurement. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Week 26
Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC Time Frame: Week 52	The number of participants who acheieved the HbA1c treatment goal (i.e., number of participants who achieved HbA1c <7% and <6.5% at Week 26) was assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Week 52
Number of Participants Who Achieved a Clinically Meaningful Improvement in the HbA1c Response Level of >=1.0%, >=1.5%, and >=2.0% at Week 52: OC Time Frame: Week 52	The number of participants who a clinically meaningful improvement from Baseline in the HbA1c response level of >=1.0%, >=1.5%, and >=2.0% at Week 52 assessed. The OC method (no imputation of missing data) was used. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.	Week 52
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52 Time Frame: Week 2 to Week 52	Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue.	Week 2 to Week 52
Time to Hyperglycemic Rescue Through Week 52 Time Frame: Week 2 to Week 52	Hyperglycemic rescue was defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days and analyzed by the central laboratory: for the Week 2 to Week 4 visit, a single FPG value >=280 milligrams per deciliter (mg/dL); for the >Week 4 and <Week 12 visits, a single FPG value >=250 mg/dL and previous titration for >=4 weeks; for the >=Week 12 and <Week 26 visits, HbA1c >=8.5% and a <=0.5% reduction from Baseline and previous titration for >=4 weeks; for the >=Week 26 and <Week 48 visits, HbA1c >=8.5% and previous titration for >=4 weeks; for the >=Week 48 and <Week 52 visits, HbA1c >=8.0% and previous titration for >=4 weeks. Time to hyperglycemia rescue is the time between the date of first dose and the date of hyperglycemia rescue plus 1 day, or the time between the date of first dose and the date of last visit during active treatment period plus 1 day for participants not requiring rescue. This time is divided by 7 to express the result in weeks.	Week 2 to Week 52
Change From Baseline in Body Weight at Week 26: LOCF Time Frame: Baseline; Week 26	Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values. Based on ANCOVA: Change = treatment + Baseline weight + renal impairment + prior myocardial infarction history + age category + region.	Baseline; Week 26
Change From Baseline in Body Weight Through Week 26: LOCF Time Frame: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26	Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used the LOCF method for missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue werre treated as missing and were replaced with pre-rescue values.	Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26
Change From Baseline in Body Weight Through Week 52: OC Time Frame: Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52	Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The Baseline weight value is defined as the last non-missing value prior to treatment. This analysis used observed weight values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.	Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 36, Week 48, and Week 52
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16 Time Frame: Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)	Sparse population pharmacokinetic (PK) data were collected for population PK and PK/pharmacodynamic (PD) analyses. Participants (par.) who received albiglutide were initiated on a 30 mg weekly dosing regimen. Beginning at Week 4, uptitration of albiglutide was allowed based on glycemic parameters. As such, albiglutide plasma conc. achieved at each sampling time represent a mixed population of par. who received either 30 mg or 50 mg weekly for various durations. The PK and PK/PD of albiglutide were characterized using a population modeling approach. Mean albiglutide plasma conc. observed at Weeks 8 and 16 are presented. Par. came to the clinic at Weeks 8 and 16 without taking albiglutide/matching placebo. The pre-dose PK sample was taken immediately prior to dosing. The Week 8 post-dose sample was taken between Weeks 8 and 10, >=2 days after a dose of medication. The Week 16 post-dose PK sample was taken any time between Weeks 16 and 20, >=2 days after the previous dose of albiglutide.	Week 8 Pre-dose (immediately prior to dose), Week 8 Post-dose (at least 2 days after a dose of medication), Week 16 Pre-dose (immediately prior to dose), and Week 16 Post-dose (at least 2 days after previous dose of albiglutide)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

Helpful Links

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 2, 2010

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

114130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Study Protocol
Information identifier: 114130

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 114130

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 114130

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: 114130

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 114130

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 114130

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: 114130

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

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Secondary Outcome Measures

Outcome Measure

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Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Study Data/Documents

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on albiglutide

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