Diabetes Mellitus, Type 2Phase 1NCT00394030
Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers
A Phase 1 study testing GSK716155 subcutaneous injections in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 6 sites in United States.
Trial summary
This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, and the impact this medication has on various substances in the blood. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- 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?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Oct 2006to 20 Mar 2007
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).
- Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.
- Women must be of non-childbearing potential.
Who cannot join
- Bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dL)
- Clinically significant hepatic enzyme elevation
- HbA1c less than 6.5 or greater than 10
- 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
Show all 14Show fewer
- 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 prior to and during the in-patient clinic stays
- Unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Miramar, Florida, 33025
GSK Investigational Site
Morrisville, North Carolina, 27560
GSK Investigational Site
Orlando, Florida, 32809
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Walnut Creek, California, 94598
About this study
Official title: An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects With Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, 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.
Read the detailed description
An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GSK716155 subcutaneous injections
- Keywords
- GSK716155 pharmacodynamics pharmacokinetics injection site
- 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
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | In Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen. Receives: Drug: GSK716155 subcutaneous injections |
| Group B | Experimental | In Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen. Receives: Drug: GSK716155 subcutaneous injections |
| Group C | Experimental | In Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen. Receives: Drug: GSK716155 subcutaneous injections |
| Group D | Experimental | In Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm. Receives: Drug: GSK716155 subcutaneous injections |
| Group E | Experimental | In Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg. Receives: Drug: GSK716155 subcutaneous injections |
| Group F | Experimental | In Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen. Receives: Drug: GSK716155 subcutaneous injections |
| Group G | Experimental | In Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm. Receives: Drug: GSK716155 subcutaneous injections |
| Group H | Experimental | In Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg. Receives: Drug: GSK716155 subcutaneous injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic measurements for different injection sites after one dose.
Measured: Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours
Secondary outcomes (1)
Pharmacodynamic measurements at three different times after one dose.
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study start16 Oct 2006
- Primary completion20 Mar 2007
- Study completion20 Mar 2007
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 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
- NCT00394030
- Sponsor's protocol ID
- GLP107724
- Status last verified
- Sep 2017
- First submitted
- 27 Oct 2006
- Last updated
- 11 Sep 2017
- 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 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects With Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
- ClinicalTrials.gov ID
- NCT00394030
- Acronym / sponsor ID
- GLP107724
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- GSK716155 pharmacodynamics pharmacokinetics injection site
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2006 (actual)
- Primary completion
- 20 Mar 2007 (actual)
- Study completion
- 20 Mar 2007 (actual)
- First posted
- 31 Oct 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 an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, 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.
Detailed description
An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: GSK716155 subcutaneous injectionsIn Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen. |
| Group B | Experimental | Drug: GSK716155 subcutaneous injectionsIn Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen. |
| Group C | Experimental | Drug: GSK716155 subcutaneous injectionsIn Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen. |
| Group D | Experimental | Drug: GSK716155 subcutaneous injectionsIn Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm. |
| Group E | Experimental | Drug: GSK716155 subcutaneous injectionsIn Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg. |
| Group F | Experimental | Drug: GSK716155 subcutaneous injectionsIn Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen. |
| Group G | Experimental | Drug: GSK716155 subcutaneous injectionsIn Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm. |
| Group H | Experimental | Drug: GSK716155 subcutaneous injectionsIn Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).
- Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.
- Women must be of non-childbearing potential.
Key exclusion criteria (14 listed)
- Bloodwork that meets certain criteria (for example, total cholesterol > 240 mg/dL)
- Clinically significant hepatic enzyme elevation
- HbA1c less than 6.5 or greater than 10
- 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 injectionsGSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered. | Drug | Group A, Group B, Group C, Group D, Group E, Group F, Group G, Group H |
Primary outcome
Pharmacokinetic measurements for different injection sites after one dose.
Time frame: Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours
1 secondary outcome
Pharmacodynamic measurements at three different times after one dose.
Time frame: Up to Day 29
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 11 Sep 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.
- Results for study GLP107724 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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK716155 subcutaneous injections in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 6 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 3 inclusion and 14 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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
Pharmacokinetic measurements for different injection sites after one dose. (time frame: Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours). 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 NCT00394030, 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 11 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.