Diabetes Mellitus, Type 2Phase 2NCT00354536
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing GSK716155 subcutaneous injections in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 5 sites in United States.
Trial summary
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GSK716155 subcutaneous injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2006to Sep 2006
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
- Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
- Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
- Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
- Women must be of non-childbearing potential.
Who cannot join
- Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL).
- Clinically significant hepatic enzyme elevation.
- Fasting plasma glucose greater than 240mg/dL.
- Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
- Any major illness other than diabetes.
- Previous use of insulin as treatment for diabetes.
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- Significant renal disease as defined by screening lab tests.
- History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.
- Smoking or use of nicotine-containing products within the previous 6 months.
- History of alcohol or drug abuse.
- Unwilling to abstain from alcohol during the study.
- Unwilling to abstain from caffeine- or xanthine-containing products during the study.
- Use of St. John's Wort during the study.
- Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
- Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
GSK Investigational Site
Honolulu, Hawaii, 96814-4224
GSK Investigational Site
Miramar, Florida, 33025
GSK Investigational Site
Orlando, Florida, 32809
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
San Antonio, Texas, 78229
About this study
Official title: A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GSK716155 subcutaneous injections, placebo injection
- Keywords
- GSK716155, albiglutide, pharmacodynamics, pharmacokinetics
- 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.
GSK716155 subcutaneous injectionsDrug
albiglutide subcutaneous injection
placebo injectionBiological
Also called placebo
placebo injection
| Study group | Role | What they receive |
|---|---|---|
| albiglutide | Active comparator | albiglutide injection Receives: Drug: GSK716155 subcutaneous injections |
| albiglutide placebo | Placebo comparator | placebo injection Receives: Biological: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood plasma levels of GSK716155
Measured: on days 2 & 9
Secondary outcomes (1)
blood plasma levels of GSK716155
Measured: on days 2 & 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT00354536
- Sponsor's protocol ID
- GLP106073
- Status last verified
- Oct 2016
- First submitted
- 18 Jul 2006
- Last updated
- 26 Oct 2016
- Results posted
- No
- 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 25387217
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00354536
- Acronym / sponsor ID
- GLP106073
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- GSK716155, albiglutide, pharmacodynamics, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 20 Jul 2006 (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.
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| albiglutide | Active comparator | Drug: GSK716155 subcutaneous injectionsalbiglutide injection |
| albiglutide placebo | Placebo comparator | Biological: placebo injectionplacebo injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
- Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
- Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
- Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
- Women must be of non-childbearing potential.
Key exclusion criteria (15 listed)
- Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL).
- Clinically significant hepatic enzyme elevation.
- Fasting plasma glucose greater than 240mg/dL.
- Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
- Any major illness other than diabetes.
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 |
|---|---|---|
| GSK716155 subcutaneous injectionsalbiglutide subcutaneous injection | Drug | albiglutide |
| placebo injectionAlso: placeboplacebo injection | Biological | albiglutide placebo |
Primary outcome
blood plasma levels of GSK716155
Time frame: on days 2 & 9
1 secondary outcome
blood plasma levels of GSK716155
Time frame: on days 2 & 9
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 26 Oct 2016.
- 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.
- 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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK716155 subcutaneous injections in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 5 sites in United States.
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 15 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
blood plasma levels of GSK716155 (time frame: on days 2 & 9). 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 NCT00354536, which also lists 1 linked publication.
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 26 Oct 2016.