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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01098539




Registration number
NCT01098539
Ethics application status
Date submitted
1/04/2010
Date registered
2/04/2010

Titles & IDs
Public title
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
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
Secondary ID [1] 0 0
114130
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - albiglutide
Treatment: Drugs - sitagliptin

Active comparator: albiglutide - albiglutide weekly subcutaneous injection + sitagliptin matching placebo

Active comparator: sitagliptin - albiglutide matching placebo + sitagliptin


Treatment: Other: 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)
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Timepoint [1] 0 0
Baseline; Week 26
Secondary outcome [1] 0 0
Mean Change From Baseline in HbA1c at Weeks 4, 8, 12, 16, and 20: LOCF
Timepoint [1] 0 0
Baseline; Weeks 4, 8, 12, 16, and 20
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
Timepoint [2] 0 0
Baseline; Weeks 4, 8, 12, 16, 20, 26, 36, 48, and 52
Secondary outcome [3] 0 0
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26
Timepoint [3] 0 0
Baseline; Week 26
Secondary outcome [4] 0 0
Mean Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, and 26: LOCF
Timepoint [4] 0 0
Baseline; Weeks 4, 8, 12, 16, 20, and 26
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
Timepoint [5] 0 0
Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 26, 36, 48, Week 52
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
Timepoint [6] 0 0
Week 26
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
Timepoint [7] 0 0
Week 26
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
Timepoint [8] 0 0
Week 52
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
Timepoint [9] 0 0
Week 52
Secondary outcome [10] 0 0
Number of Participants With the Indicated Time to Hyperglycemic Rescue Through Week 52
Timepoint [10] 0 0
Week 2 to Week 52
Secondary outcome [11] 0 0
Time to Hyperglycemic Rescue Through Week 52
Timepoint [11] 0 0
Week 2 to Week 52
Secondary outcome [12] 0 0
Change From Baseline in Body Weight at Week 26: LOCF
Timepoint [12] 0 0
Baseline; Week 26
Secondary outcome [13] 0 0
Change From Baseline in Body Weight Through Week 26: LOCF
Timepoint [13] 0 0
Baseline; Week 1, Week 2 , Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26
Secondary outcome [14] 0 0
Change From Baseline in Body Weight Through Week 52: OC
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
Secondary outcome [15] 0 0
Plasma Concentrations (Conc.) of Albiglutide at Week 8 and Week 16
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)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
507
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [3] 0 0
GSK Investigational Site - Auchenflower
Recruitment hospital [4] 0 0
GSK Investigational Site - Caboolture
Recruitment hospital [5] 0 0
GSK Investigational Site - Herston
Recruitment hospital [6] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [7] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [8] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [9] 0 0
GSK Investigational Site - Heidelberg
Recruitment hospital [10] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [11] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [12] 0 0
GSK Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4510 - Caboolture
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3081 - Heidelberg
Recruitment postcode(s) [10] 0 0
3135 - Melbourne
Recruitment postcode(s) [11] 0 0
3050 - Parkville
Recruitment postcode(s) [12] 0 0
6160 - Fremantle
Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
Country [5] 0 0
United States of America
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Georgia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01098539