Diabetes Mellitus, Type 2Phase 1NCT01147861
A Phase 1 Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA Levels in Type 2 Diabetics
A Phase 1 study testing GSK256073 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 4 sites in United States.
Trial summary
The aim of this study is to verify whether a significant decrease in glucose levels can be achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels and a placebo will be evaluated in a three period crossover study with two active doses and one placebo dose per subject, in order to… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GSK256073
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2010to 7 Sep 2010
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with documented (not less than 6 months prior to screening) type 2 diabetes mellitus diagnosis with:
- HbA1c levels greater than 6.5 percent and less than or equal to 9.5 percent at screening,
- On monotherapy with metformin at the time of screening, and at a todal daily dose greater than or equal to 1000 mg at the time of dosing,
- Fasting plasma glucose level less than 270 mg/dl at screening
- Male or female between 20 and 70 years of age inclusive, at the time of signing the informed consent
- Waist circumference above 102cm (40 inches) for men, and 88cm (35 inches) for women
- Fasting triglycerides between 150 mg/dl and 500 mg/dl, inclusive
- BMI within the range of 22-37 kg/meter squared, inclusive
Who cannot join
- A subject will not eligible for inclusion in this study if any of the following criteria apply:
- Requiring insulin therapy or use of combination oral antidiabetic medications or use of monotherapy other than metformin within the 3 months prior to screening
- Past or present disease (other than type 2 diabetes mellitus) that in the opinion of the Investigator may affect the outcome of this study. These diseases include the following but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, gastrointestinal disease and endocrine disease
- A positive pre-study Hepatitis B surface antigen, or positive Hepatitis C or HIV antibody result within 3 months of screening
- Renal impairment as defined by a calculated GFR less than 60 ml/min
- Any concurrent serious illness (e.g., severe COPD, history of malignancy other than skin cancer within 5 years of initial diagnosis or with evidence of recurrence) that may interfere with a subject completing the study
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- Clinical laboratory values as defined per protocol
- ECG parameters as defined per protocol
- History of gout and/or hyperuricemia/uric acid kidney stone or treated with drugs for hyperuricemia: allopurinol and/or probenecid
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Use of the following blood pressure medications or other medications renally excreted via OAT is prohibited: Enalapril (at any dose), Losartan (at any dose), Captopril (at any dose)
- Pregnant females as determined by positive serum hCG test at screening or positive urine hCG test prior to dosing
- Lactating females
Trial locations and contacts
4 sites in 1 country.
United States4 sites
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Miami, Florida, 33169
GSK Investigational Site
Miami Gardens, Florida, 33169
GSK Investigational Site
San Antonio, Texas, 78229
About this study
Official title: A Randomized, Single Blind, Placebo-controlled, Three Period Crossover, Dose Selection Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA 24 Hour Profile in Type 2 Diabetic Patients.
The aim of this study is to verify whether a significant decrease in glucose levels can be achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels and a placebo will be evaluated in a three period crossover study with two active doses and one placebo dose per subject, in order to determine whether there is a dose that produces glucose lowering in the target population. In addition, this study will investigate the optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by comparing once a day versus twice a day regimens.
Read the detailed description
This is a multi-center study that will enroll approximately 36 subjects. The study consists of three periods of two days of dosing each. The study will evaluate 5 potential dose regimens. Each subject will receive a randomized sequence of treatments over three periods, with placebo treatment in one period and two different active dose regimens in the other two periods. There will be 5 to 12 days of outpatient washout between treatment periods. Subjects will continue their current treatment on metformin throughout the study. Subjects will monitor blood glucose levels daily via glucometer during oupatient washout periods. A follow-up visit will occur between 5 and 10 days after the last period of the study.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GSK256073, Placebo
- Keywords
- T2DM, Pharmacodynamics, GSK256073
- 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.
GSK256073Drug
5mg in the AM and 5mg in the PM
GSK256073Drug
10mg in the AM
GSK256073Drug
50mg in the AM
GSK256073Drug
25mg in the AM and 25mg in the PM
PlaceboOther
2 placebo tablets in the AM and 2 placebo tablets in the PM
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will receive 2 placebo tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2. Receives: Other: Placebo |
| 5mg BID | Other | Subjects will receive 1 x 5mg tablet and 1 placebo tablet in the morning, and 1 x 5mg tablet and 1 placebo tablet in the evening on Day 1 and Day 2. Receives: Drug: GSK256073 |
| 10mg QD | Other | Subjects will receive 2 x 5mg tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2. Receives: Drug: GSK256073 |
| 25mg BID | Other | Subjects will receive 1 x 25mg tablet and 1 placebo tablet in the morning, and 1 x 25mg tablet and 1 placebo tablet in the evening on Day 1 and Day 2. Receives: Drug: GSK256073 |
| 50mg QD | Other | Subjects will receive 2 x 25mg tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2. Receives: Drug: GSK256073 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weighted mean AUC for glucose
Measured: 24 hours
Secondary outcomes (1)
Weighted mean AUC for NEFA, glycerol, triglycerides, insulin, and C-peptide
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study start1 Jul 2010
- Primary completion7 Sep 2010
- Study completion7 Sep 2010
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 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
- NCT01147861
- Sponsor's protocol ID
- 114187
- Status last verified
- Jun 2017
- First submitted
- 17 Jun 2010
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- 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
Dobbins RL, Shearn SP, Byerly RL, Gao FF, Mahar KM, Napolitano A, Nachbaur GJ, Le Monnier de Gouville AC. GSK256073, a selective agonist of G-protein coupled receptor 109A (GPR109A) reduces serum glucose in subjects with type 2 diabetes mellitus. Diabetes Obes Metab. 2013 Nov;15(11):1013-21. doi: 10.1111/dom.12132. Epub 2013 Jun 12.
PubMed 23701262
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Placebo-controlled, Three Period Crossover, Dose Selection Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA 24 Hour Profile in Type 2 Diabetic Patients.
- ClinicalTrials.gov ID
- NCT01147861
- Acronym / sponsor ID
- 114187
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- T2DM, Pharmacodynamics, GSK256073
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 7 Sep 2010 (actual)
- Study completion
- 7 Sep 2010 (actual)
- First posted
- 22 Jun 2010 (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 aim of this study is to verify whether a significant decrease in glucose levels can be achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels and a placebo will be evaluated in a three period crossover study with two active doses and one placebo dose per subject, in order to determine whether there is a dose that produces glucose lowering in the target population. In addition, this study will investigate the optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by comparing once a day versus twice a day regimens.
Detailed description
This is a multi-center study that will enroll approximately 36 subjects. The study consists of three periods of two days of dosing each. The study will evaluate 5 potential dose regimens. Each subject will receive a randomized sequence of treatments over three periods, with placebo treatment in one period and two different active dose regimens in the other two periods. There will be 5 to 12 days of outpatient washout between treatment periods. Subjects will continue their current treatment on metformin throughout the study. Subjects will monitor blood glucose levels daily via glucometer during oupatient washout periods. A follow-up visit will occur between 5 and 10 days after the last period of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboSubjects will receive 2 placebo tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2. |
| 5mg BID | Other | Drug: GSK256073Subjects will receive 1 x 5mg tablet and 1 placebo tablet in the morning, and 1 x 5mg tablet and 1 placebo tablet in the evening on Day 1 and Day 2. |
| 10mg QD | Other | Drug: GSK256073Subjects will receive 2 x 5mg tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2. |
| 25mg BID | Other | Drug: GSK256073Subjects will receive 1 x 25mg tablet and 1 placebo tablet in the morning, and 1 x 25mg tablet and 1 placebo tablet in the evening on Day 1 and Day 2. |
| 50mg QD | Other | Drug: GSK256073Subjects will receive 2 x 25mg tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with documented (not less than 6 months prior to screening) type 2 diabetes mellitus diagnosis with:
- HbA1c levels greater than 6.5 percent and less than or equal to 9.5 percent at screening,
- On monotherapy with metformin at the time of screening, and at a todal daily dose greater than or equal to 1000 mg at the time of dosing,
- Fasting plasma glucose level less than 270 mg/dl at screening
- Male or female between 20 and 70 years of age inclusive, at the time of signing the informed consent
Key exclusion criteria (13 listed)
- A subject will not eligible for inclusion in this study if any of the following criteria apply:
- Requiring insulin therapy or use of combination oral antidiabetic medications or use of monotherapy other than metformin within the 3 months prior to screening
- Past or present disease (other than type 2 diabetes mellitus) that in the opinion of the Investigator may affect the outcome of this study. These diseases include the following but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, gastrointestinal disease and endocrine disease
- A positive pre-study Hepatitis B surface antigen, or positive Hepatitis C or HIV antibody result within 3 months of screening
- Renal impairment as defined by a calculated GFR less than 60 ml/min
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 |
|---|---|---|
| GSK2560735mg in the AM and 5mg in the PM | Drug | 5mg BID |
| GSK25607310mg in the AM | Drug | 10mg QD |
| GSK25607350mg in the AM | Drug | 50mg QD |
| GSK25607325mg in the AM and 25mg in the PM | Drug | 25mg BID |
| Placebo2 placebo tablets in the AM and 2 placebo tablets in the PM | Other | Placebo |
Primary outcome
Weighted mean AUC for glucose
Time frame: 24 hours
1 secondary outcome
Weighted mean AUC for NEFA, glycerol, triglycerides, insulin, and C-peptide
Time frame: 24 hours
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 14 Jun 2017.
- Background: PubMed 23701262Dobbins RL, Shearn SP, Byerly RL, Gao FF, Mahar KM, Napolitano A, Nachbaur GJ, Le Monnier de Gouville AC. GSK256073, a selective agonist of G-protein coupled receptor 109A (GPR109A) reduces serum glucose in subjects with type 2 diabetes mellitus. Diabetes Obes Metab. 2013 Nov;15(11):1013-21. doi: 10.1111/dom.12132. Epub 2013 Jun 12.
- 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 114187 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.
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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
4 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 GSK256073 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 4 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 8 inclusion and 13 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Weighted mean AUC for glucose (time frame: 24 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 NCT01147861, 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 14 Jun 2017.