Diabetes Mellitus, Type 2Phase 1NCT00938158
A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
A Phase 1 study testing albiglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 7 sites in 2 countries.
Trial summary
The purpose of this study is to assess the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function, including subjects requiring hemodialysis. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- albiglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 5 Aug 2009to 12 Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- normal renal function or renal impairment
- stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200mL/min (cohort 3 only)
- neither pregnant nor lactating
- HbA1c 6-10.5% inclusive
- females of childbearing potential must be practicing adequate contraception.
Who cannot join
- inability to meet the PK objectives of the study
- history of hypoglycemia unawareness or severe hypoglycemia
- liver function tests greater than or equal to 2 times the ULN
- clinically significant cardiovascular and/or cerebrovascular disease
- positive test results for hepatitis B, hepatitis C, or HIV
- documented hypertension or hypotension at screening
Show all 12Show fewer
- known hepatic or biliary abnormalities
- current use of sulfonylureas
- active history of tobacco use within 6 months before screening
- donation of blood in excess of 500mL within 56 days before albiglutide dosing
- receipt of any investigational drug within the 30days or 5 half lives, whichever is longer, before dosing
- previous or current receipt of exenatide or any other GLP-1 agonist
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Baton Rouge, Louisiana, 70806
GSK Investigational Site
Miami, Florida, 33169
GSK Investigational Site
Minneapolis, Minnesota, 55404
GSK Investigational Site
Orlando, Florida, 32809
South Africa2 sites
GSK Investigational Site
Parktown, Gauteng, 2193
GSK Investigational Site
Somerset West, 07129
About this study
Official title: An Adaptive Design Study for the Assessment of the Pharmacokinetics of Albiglutide in Subjects With Normal Renal Function and Subjects With Moderate-to-severe Renal Impairment and Hemodialysis.
The purpose of this study is to assess the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function, including subjects requiring hemodialysis.
Read the detailed description
This adaptive design, non-randomized, open-label, staggered parallel group study evaluates the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function. During Stage 1, a single dose of albiglutide will be administered to subjects with normal renal function and subjects with moderate-to-severe renal impairment not requiring hemodialysis. In addition to subjects with normal renal function and moderate renal impairment, Stage 2 of the study will also include cohorts of subjects requiring hemodialysis, subjects with severe renal impairment not requiring hemodialysis, and potentially subjects with mild renal impairment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- albiglutide
- Keywords
- albiglutide, hemodialysis, pharmacokinetics, renal
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albiglutideBiological
single dose of subcutaneously injected albiglutide
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 normal renal function | Experimental | Subject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min) Receives: Biological: albiglutide |
| Stage 1 moderate/severe renal function | Experimental | Subject with estimated GFR >= 20 mL/min and less than 50 mL/min Receives: Biological: albiglutide |
| Stage 2 normal renal function | Experimental | Subject with GFR greater than 80 mL/min Receives: Biological: albiglutide |
| Stage 2 moderate renal impairment | Experimental | Subject with estimated GFR >= 30 mL/min and less than 50 mL/min Receives: Biological: albiglutide |
| Stage 2 subjects requiring hemodialysis | Experimental | Subjects who require hemodialysis Receives: Biological: albiglutide |
| Stage 2 severe renal impairment not requiring hemodialysis | Experimental | Subjects with GFR less than 30 mL/min Receives: Biological: albiglutide |
| Stage 2 mild renal impairment | Experimental | Subjects with GFR >= 50 mL/min and <= 80 mL/min Receives: Biological: albiglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to characterize the PK of albiglutide in subjects with type 2 diabetes and varying degrees of renal impairment, including subjects requiring hemodialysis, and in age, gender and BMI-matched subjects.
Measured: 42 days
Secondary outcomes (3)
To assess the PK of albiglutide in subjects with varying degrees of proteinuria
Measured: 42 days
To assess the effects of hemodialysis on the overall PK profile of albiglutide
Measured: 42 days
To assess the safety and tolerability of a single dose of albiglutide in subjects with varying degrees of renal impairment and in age, gender and BMI-matched subjects with normal renal function
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study start5 Aug 2009
- Primary completion12 Apr 2011
- Study completion12 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938158
- Sponsor's protocol ID
- 108370
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2009
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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.
PubMed 25387217Young MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med. 2014 May;126(3):35-46. doi: 10.3810/pgm.2014.05.2754.
PubMed 24918790
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Design Study for the Assessment of the Pharmacokinetics of Albiglutide in Subjects With Normal Renal Function and Subjects With Moderate-to-severe Renal Impairment and Hemodialysis.
- ClinicalTrials.gov ID
- NCT00938158
- Acronym / sponsor ID
- 108370
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- albiglutide, hemodialysis, pharmacokinetics, renal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2009 (actual)
- Primary completion
- 12 Apr 2011 (actual)
- Study completion
- 12 Apr 2011 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function, including subjects requiring hemodialysis.
Detailed description
This adaptive design, non-randomized, open-label, staggered parallel group study evaluates the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function. During Stage 1, a single dose of albiglutide will be administered to subjects with normal renal function and subjects with moderate-to-severe renal impairment not requiring hemodialysis. In addition to subjects with normal renal function and moderate renal impairment, Stage 2 of the study will also include cohorts of subjects requiring hemodialysis, subjects with severe renal impairment not requiring hemodialysis, and potentially subjects with mild renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Stage 1 normal renal function | Experimental | Biological: albiglutideSubject with estimated glomerular filtration rate (GFR) greater than 80 milliliter per minute (mL/min) |
| Stage 1 moderate/severe renal function | Experimental | Biological: albiglutideSubject with estimated GFR >= 20 mL/min and less than 50 mL/min |
| Stage 2 normal renal function | Experimental | Biological: albiglutideSubject with GFR greater than 80 mL/min |
| Stage 2 moderate renal impairment | Experimental | Biological: albiglutideSubject with estimated GFR >= 30 mL/min and less than 50 mL/min |
| Stage 2 subjects requiring hemodialysis | Experimental | Biological: albiglutideSubjects who require hemodialysis |
| Stage 2 severe renal impairment not requiring hemodialysis | Experimental | Biological: albiglutideSubjects with GFR less than 30 mL/min |
| Stage 2 mild renal impairment | Experimental | Biological: albiglutideSubjects with GFR >= 50 mL/min and <= 80 mL/min |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- normal renal function or renal impairment
- stable hemodialysis treatment for at least 3 months before screening and able to tolerate a hemodialysis treatment lasting 3-4 hours with blood flow rates of >200mL/min (cohort 3 only)
- neither pregnant nor lactating
- HbA1c 6-10.5% inclusive
- females of childbearing potential must be practicing adequate contraception.
Key exclusion criteria (12 listed)
- inability to meet the PK objectives of the study
- history of hypoglycemia unawareness or severe hypoglycemia
- liver function tests greater than or equal to 2 times the ULN
- clinically significant cardiovascular and/or cerebrovascular disease
- positive test results for hepatitis B, hepatitis C, or HIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albiglutidesingle dose of subcutaneously injected albiglutide | Biological | Stage 1 moderate/severe renal function, Stage 1 normal renal function, Stage 2 mild renal impairment, Stage 2 moderate renal impairment, Stage 2 normal renal function, Stage 2 severe renal impairment not requiring hemodialysis, Stage 2 subjects requiring hemodialysis |
Primary outcome
The primary objective is to characterize the PK of albiglutide in subjects with type 2 diabetes and varying degrees of renal impairment, including subjects requiring hemodialysis, and in age, gender and BMI-matched subjects.
Time frame: 42 days
3 secondary outcomes
To assess the PK of albiglutide in subjects with varying degrees of proteinuria
Time frame: 42 days
To assess the effects of hemodialysis on the overall PK profile of albiglutide
Time frame: 42 days
To assess the safety and tolerability of a single dose of albiglutide in subjects with varying degrees of renal impairment and in age, gender and BMI-matched subjects with normal renal function
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 25387217Young 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.
- Derived from this study: PubMed 24918790Young MA, Wald JA, Matthews JE, Yang F, Reinhardt RR. Effect of renal impairment on the pharmacokinetics, efficacy, and safety of albiglutide. Postgrad Med. 2014 May;126(3):35-46. doi: 10.3810/pgm.2014.05.2754.
- Results for study 108370 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing albiglutide in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to characterize the PK of albiglutide in subjects with type 2 diabetes and varying degrees of renal impairment, including subjects requiring hemodialysis, and in age, gender and BMI-matched subjects. (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00938158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.