Diabetes Mellitus, Type 2Phase 1NCT00537719
Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.
A Phase 1 study testing GSK716155 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will use scintigraphy techniques to measure gastric emptying rate of liquid and solid food at baseline and after administration of GSK716155 or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GSK716155
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2007to 4 Apr 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men or women, between the ages of 18 and 65, and have a Body Mass Index (BMI) of between 20 and 32.
- If female, the subject must be not be capable of having children.
Who cannot join
- Subjects must not use tobacco, nicotine, or illegal drugs of abuse, and must not take caffeine or alcohol for 24 hours before dosing and before each set of scintigraphy procedures.
- Subjects may not have HIV, hepatitis, elevated fasting blood sugar levels, high blood pressure, heart, lung, liver, gall bladder, gastrointestinal, pancreatic, or kidney disease, or untreated thyroid disease.
- Subjects must not have a history of alcohol abuse, must not take prescription or non-prescription drugs within 7 days of Day 1 and Day 8 of the study, and must not have previous exposure to any GLP-1 mimetic or exenatide.
- Prior radiation exposures must meet certain limits in order to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Blind, Randomized, Placebo-Controlled Study in Healthy Men and Women to Determine the Effect of Single Subcutaneous Injections of GSK716155 on Gastric Emptying Time for Solid and Liquid Components of a Meal
This study will use scintigraphy techniques to measure gastric emptying rate of liquid and solid food at baseline and after administration of GSK716155 or placebo.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GSK716155, Placebo
- Keywords
- healthy, pharmacodynamics, glucagon-like peptide 1, pharmacokinetics, scintigraphy, radiation, albiglutide
- 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.
GSK716155Drug
albiglutide subcutaneous injection
PlaceboDrug
Also called GSK716155
placebo injection
| Study group | Role | What they receive |
|---|---|---|
| GSK716155 | Active comparator | albiglutide subcutaneous injection Receives: Drug: GSK716155 |
| placebo | Placebo comparator | placebo injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the time to 50% gastric emptying (gastric emptying t½) of the solid and liquid components of a meal at 72 hours after dosing in healthy volunteers.
Measured: 3 Days
Secondary outcomes (1)
Exploratory correlation of % contents remaining in stomach after a meal.GSK716155 concentration before meal & at the time gastric emptying is complete. Safety and tolerability parameters each visit.
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study start7 Dec 2007
- Primary completion4 Apr 2008
- Study completion4 Apr 2008
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 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
- NCT00537719
- Sponsor's protocol ID
- GLP107030
- Status last verified
- Aug 2017
- First submitted
- 28 Sep 2007
- Last updated
- 17 Aug 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 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Blind, Randomized, Placebo-Controlled Study in Healthy Men and Women to Determine the Effect of Single Subcutaneous Injections of GSK716155 on Gastric Emptying Time for Solid and Liquid Components of a Meal
- ClinicalTrials.gov ID
- NCT00537719
- Acronym / sponsor ID
- GLP107030
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- healthy, pharmacodynamics, glucagon-like peptide 1, pharmacokinetics, scintigraphy, radiation, albiglutide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2007 (actual)
- Primary completion
- 4 Apr 2008 (actual)
- Study completion
- 4 Apr 2008 (actual)
- First posted
- 1 Oct 2007 (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 will use scintigraphy techniques to measure gastric emptying rate of liquid and solid food at baseline and after administration of GSK716155 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK716155 | Active comparator | Drug: GSK716155albiglutide subcutaneous injection |
| placebo | Placebo comparator | Drug: Placeboplacebo injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy men or women, between the ages of 18 and 65, and have a Body Mass Index (BMI) of between 20 and 32.
- If female, the subject must be not be capable of having children.
Key exclusion criteria (4 listed)
- Subjects must not use tobacco, nicotine, or illegal drugs of abuse, and must not take caffeine or alcohol for 24 hours before dosing and before each set of scintigraphy procedures.
- Subjects may not have HIV, hepatitis, elevated fasting blood sugar levels, high blood pressure, heart, lung, liver, gall bladder, gastrointestinal, pancreatic, or kidney disease, or untreated thyroid disease.
- Subjects must not have a history of alcohol abuse, must not take prescription or non-prescription drugs within 7 days of Day 1 and Day 8 of the study, and must not have previous exposure to any GLP-1 mimetic or exenatide.
- Prior radiation exposures must meet certain limits in order to participate in this study.
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 |
|---|---|---|
| GSK716155albiglutide subcutaneous injection | Drug | GSK716155 |
| PlaceboAlso: GSK716155placebo injection | Drug | placebo |
Primary outcome
Change from baseline of the time to 50% gastric emptying (gastric emptying t½) of the solid and liquid components of a meal at 72 hours after dosing in healthy volunteers.
Time frame: 3 Days
1 secondary outcome
Exploratory correlation of % contents remaining in stomach after a meal.GSK716155 concentration before meal & at the time gastric emptying is complete. Safety and tolerability parameters each visit.
Time frame: 3 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 17 Aug 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.
- 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.
- Results for study GLP107030 can be found on the GSK Clinical Study Register.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.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
1 site 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 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site 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 2 inclusion and 4 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Change from baseline of the time to 50% gastric emptying (gastric emptying t½) of the solid and liquid components of a meal at 72 hours after dosing in healthy volunteers. (time frame: 3 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 NCT00537719, 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 17 Aug 2017.