Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01098539
Registration number
NCT01098539
Ethics application status
Date submitted
1/04/2010
Date registered
2/04/2010
Date last updated
28/02/2017
Titles & IDs
Public title
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
114130
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
0
0
Query!
Condition category
Condition code
Renal and Urogenital
0
0
0
0
Query!
Kidney disease
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - albiglutide
Treatment: Drugs - sitagliptin
Active Comparator: albiglutide - albiglutide weekly subcutaneous injection + sitagliptin matching placebo
Active Comparator: sitagliptin - albiglutide matching placebo + sitagliptin
Other interventions: albiglutide
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
Treatment: Drugs: sitagliptin
albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)
Query!
Intervention code [1]
0
0
Other interventions
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline; Week 26
Query!
Secondary outcome [1]
0
0
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline; Weeks 4, 8, 12, 16, and 20
Query!
Secondary outcome [2]
0
0
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, 20, 26, 36, 48, and Week 52: Observed Cases
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52
Query!
Secondary outcome [3]
0
0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline; Week 26
Query!
Secondary outcome [4]
0
0
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline; Weeks 4, 8, 12, 16, 20, and 26
Query!
Secondary outcome [5]
0
0
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
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52
Query!
Secondary outcome [6]
0
0
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5% and <7.0% at Week 26: LOCF
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Week 26
Query!
Secondary outcome [7]
0
0
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
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Week 26
Query!
Secondary outcome [8]
0
0
Number of Participants Who Achieved a Clinically Meaningful HbA1c Response Level of <6.5% and <7.0% at Week 52: OC
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Week 52
Query!
Secondary outcome [9]
0
0
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
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Week 52
Query!
Secondary outcome [10]
0
0
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Week 2 to Week 52
Query!
Secondary outcome [11]
0
0
Time to Hyperglycemic Rescue Through Week 52
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Week 2 to Week 52
Query!
Secondary outcome [12]
0
0
Change From Baseline in Body Weight at Week 26: LOCF
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline; Week 26
Query!
Secondary outcome [13]
0
0
Change From Baseline in Body Weight Through Week 26: LOCF
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26
Query!
Secondary outcome [14]
0
0
Change From Baseline in Body Weight Through Week 52: OC
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
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
Query!
Secondary outcome [15]
0
0
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
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)
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
507
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Garran
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Camperdown
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Auchenflower
Query!
Recruitment hospital [4]
0
0
GSK Investigational Site - Caboolture
Query!
Recruitment hospital [5]
0
0
GSK Investigational Site - Herston
Query!
Recruitment hospital [6]
0
0
GSK Investigational Site - Kippa Ring
Query!
Recruitment hospital [7]
0
0
GSK Investigational Site - Box Hill
Query!
Recruitment hospital [8]
0
0
GSK Investigational Site - Clayton
Query!
Recruitment hospital [9]
0
0
GSK Investigational Site - Heidelberg
Query!
Recruitment hospital [10]
0
0
GSK Investigational Site - Melbourne
Query!
Recruitment hospital [11]
0
0
GSK Investigational Site - Parkville
Query!
Recruitment hospital [12]
0
0
GSK Investigational Site - Fremantle
Query!
Recruitment postcode(s) [1]
0
0
2606 - Garran
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [4]
0
0
4510 - Caboolture
Query!
Recruitment postcode(s) [5]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [6]
0
0
4021 - Kippa Ring
Query!
Recruitment postcode(s) [7]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [8]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [9]
0
0
3081 - Heidelberg
Query!
Recruitment postcode(s) [10]
0
0
3135 - Melbourne
Query!
Recruitment postcode(s) [11]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [12]
0
0
6160 - Fremantle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Iowa
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maine
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nevada
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New York
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oklahoma
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oregon
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Tennessee
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Texas
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Utah
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Vermont
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Washington
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Rio Grande Do Sul
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Brasília
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Mogi das Cruzes
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
São Paulo
Query!
Country [35]
0
0
Colombia
Query!
State/province [35]
0
0
Barrangquilla
Query!
Country [36]
0
0
Colombia
Query!
State/province [36]
0
0
Bogota
Query!
Country [37]
0
0
Colombia
Query!
State/province [37]
0
0
Floridablanca-Santander
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Hessen
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Niedersachsen
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Rheinland-Pfalz
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Sachsen
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Berlin
Query!
Country [43]
0
0
India
Query!
State/province [43]
0
0
Ahmedabad
Query!
Country [44]
0
0
India
Query!
State/province [44]
0
0
Bangalore
Query!
Country [45]
0
0
India
Query!
State/province [45]
0
0
Belgaum,
Query!
Country [46]
0
0
India
Query!
State/province [46]
0
0
Belgaum
Query!
Country [47]
0
0
India
Query!
State/province [47]
0
0
Chennai
Query!
Country [48]
0
0
India
Query!
State/province [48]
0
0
Lucknow
Query!
Country [49]
0
0
India
Query!
State/province [49]
0
0
Manipal
Query!
Country [50]
0
0
India
Query!
State/province [50]
0
0
Mumbai
Query!
Country [51]
0
0
India
Query!
State/province [51]
0
0
Nasik
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Ashkelon
Query!
Country [53]
0
0
Israel
Query!
State/province [53]
0
0
Beer-Sheva
Query!
Country [54]
0
0
Israel
Query!
State/province [54]
0
0
Haifa
Query!
Country [55]
0
0
Israel
Query!
State/province [55]
0
0
Holon
Query!
Country [56]
0
0
Israel
Query!
State/province [56]
0
0
Kfar Saba
Query!
Country [57]
0
0
Israel
Query!
State/province [57]
0
0
Safed
Query!
Country [58]
0
0
Korea, Republic of
Query!
State/province [58]
0
0
Seongnam-si
Query!
Country [59]
0
0
Korea, Republic of
Query!
State/province [59]
0
0
Seoul
Query!
Country [60]
0
0
Korea, Republic of
Query!
State/province [60]
0
0
Suwon, Kyonggi-do
Query!
Country [61]
0
0
Peru
Query!
State/province [61]
0
0
Lima
Query!
Country [62]
0
0
Peru
Query!
State/province [62]
0
0
Arequipa
Query!
Country [63]
0
0
Peru
Query!
State/province [63]
0
0
Ica
Query!
Country [64]
0
0
Peru
Query!
State/province [64]
0
0
Piura
Query!
Country [65]
0
0
Peru
Query!
State/province [65]
0
0
Trujillo
Query!
Country [66]
0
0
Philippines
Query!
State/province [66]
0
0
Cebu City
Query!
Country [67]
0
0
Philippines
Query!
State/province [67]
0
0
Iloilo City
Query!
Country [68]
0
0
Philippines
Query!
State/province [68]
0
0
Makati City
Query!
Country [69]
0
0
Philippines
Query!
State/province [69]
0
0
Pasay
Query!
Country [70]
0
0
Philippines
Query!
State/province [70]
0
0
Tagbilaran City
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Nizhniy Novgorod
Query!
Country [72]
0
0
Russian Federation
Query!
State/province [72]
0
0
Saratov
Query!
Country [73]
0
0
Russian Federation
Query!
State/province [73]
0
0
St'Petersburg
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Yaroslavl
Query!
Country [75]
0
0
South Africa
Query!
State/province [75]
0
0
Eastern Cape
Query!
Country [76]
0
0
South Africa
Query!
State/province [76]
0
0
Gauteng
Query!
Country [77]
0
0
South Africa
Query!
State/province [77]
0
0
KwaZulu- Natal
Query!
Country [78]
0
0
South Africa
Query!
State/province [78]
0
0
Houghton
Query!
Country [79]
0
0
South Africa
Query!
State/province [79]
0
0
Pretoria
Query!
Country [80]
0
0
South Africa
Query!
State/province [80]
0
0
Somerset West
Query!
Country [81]
0
0
South Africa
Query!
State/province [81]
0
0
Tygerberg
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Alicante
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
La Coruña
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Málaga
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Palma de Mallorca
Query!
Country [86]
0
0
Spain
Query!
State/province [86]
0
0
Santiago de Compostela
Query!
Country [87]
0
0
Spain
Query!
State/province [87]
0
0
Sevilla
Query!
Country [88]
0
0
Spain
Query!
State/province [88]
0
0
Torrevieja (Alicante)
Query!
Country [89]
0
0
Taiwan
Query!
State/province [89]
0
0
Kaohsiung
Query!
Country [90]
0
0
Taiwan
Query!
State/province [90]
0
0
Taichung
Query!
Country [91]
0
0
Taiwan
Query!
State/province [91]
0
0
Tainan
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
West Midlands
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Birmingham
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Hertfordshire
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Hull
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Liverpool
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Livingston
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
London
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Plymouth
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Swansea
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01098539
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01098539
Download to PDF