Diabetes Mellitus, Type 2Phase 1NCT00733577
A Study to Test How SB756050 Affects Subjects With Type 2 Diabetes Mellitus After 6 Days of Dosing.
A Phase 1 study testing SB756050 in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 4 sites in United States.
Trial summary
This is an escalating dose study in subjects with T2DM, which will consist of four overlapping cohorts receiving 6 days of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SB756050
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Aug 2008to 3 Mar 2009
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects, 18 - 60 years of age, inclusive, at the time of signing the informed consent
- A female subject is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. FSH and estradiol levels will be checked at Screening for postmenopausal women. Simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory.
- Except as noted elsewhere, subjects should have no significant known medical conditions other than T2DM, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters that meets exclusion criteria but is outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- BMI (body mass index) within the range 25-35 kg/m2, inclusive.
- T2DM diagnosed at least 3 months prior to Screening
- Subjects must be treating their T2DM using one of the following regimens: Diet and exercise therapy, Metformin as monotherapy, Sulfonylurea as monotherapy, Metformin and sulfonylurea in combination, DPP-IV inhibitors, either as monotherapy or in combination with other agent(s) on this list at half maximal dose or less, Exenatide, either as monotherapy or in combination with other agent(s) on this list All doses of anti-diabetic medication must have been stable for at least 3 months prior to Screening, and the subject must be willing to wash out from their antidiabetic medications from Day -7 through Day 7.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Has positive pre-study Hepatitis B surface antigen or positive Hepatitis C, result within 3 months of screening. Positive test for HIV antibody. History of uncorrected thyroid dysfunction. ALT and/or AST > 2 times the upper limit of normal at screening. Fasting triglycerides > 450mg/dL at screening. Total Bilirubin > 1.5 times the upper limit of normal at screening. A positive pre-study drug/urine screen and tobacco screen.
- Significant renal disease
- Significant ECG abnormalities
- Systolic pressure > 150 mmHg or <80 mmHg or diastolic blood pressure > 95 mmHg or <60 mmHg at screening.
- Previous use of insulin as a treatment within 3 months of Screening, or for >2 weeks when used for acute illness in the last 12 months prior to Screening, or if used for more than 1 year when associated with GDM.
- Has a history of gastrointestinal disease that could affect absorption within the past year, Gastrointestinal surgery, Chronic or acute pancreatitis.
Show all 16Show fewer
- History of regular alcohol consumption
- Smoked or used tobacco or nicotine-containing products within the previous 6 months.
- Has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Is taking prohibited medications.
- Unwilling to abstain from caffeine-or xanthine-containing products for 24 hours prior to dosing until Day 7, Use of illicit drugs or nicotine-containing products, Alcohol for 24 hours prior to dosing until Day 7, Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood samples
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. This includes sensitivity to heparin, if heparin will be used to maintain catheter patency.
- Where participation in the study would result in donation of blood in excess of 500 mL within a 56 day period.
- Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
GSK Investigational Site
Hackensack, New Jersey, 07601
GSK Investigational Site
Miami, Florida, 33169
GSK Investigational Site
Orlando, Florida, 32809
GSK Investigational Site
San Antonio, Texas, 78209
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 Oral SB756050 Administered for 6 Days to Subjects With Type 2 Diabetes Mellitus
This is an escalating dose study in subjects with T2DM, which will consist of four overlapping cohorts receiving 6 days of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- SB756050
- Keywords
- diabetes, pharmacodynamics, safety, pharmacokinetics
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB756050Drug
doses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 15 mg SB756050 or placebo Receives: Drug: SB756050 |
| Cohort 2 | Experimental | Planned dose for Cohorts 2 50mg SB756050 or placebo Receives: Drug: SB756050 |
| Cohort 3 | Experimental | Planned dose for Cohort 3 150mg SB756050 or placebo Receives: Drug: SB756050 |
| Cohort 4 | Experimental | Planned dose for Cohort 4 600mg SB756050 or placebo Receives: Drug: SB756050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures including: AEs daily; laboratory testing: day -1,2,5,7 and follow up; ECG: day -1, 2, 5, 6, 7 and follow-up; vital signs: daily; PK parameters day -1,5, and 6.
Measured: 6 days of dosing
Secondary outcomes (3)
Pharmacodynamic endpoints will include fasting and meal or OGTT-related weighted mean AUC for glucose, GLP-1 (total and active), glucagon, insulin, PYY (active) and C-peptide levels.
Measured: 6 days of dosing
Safety and tolerability parameters including adverse events, clinical laboratory, ECGs and vital signs assessments.
Measured: 6 days of dosing
Subject reports of hunger and craving as reported on the Hunger and Craving questionnaire
Measured: 6 days of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study start11 Aug 2008
- Primary completion3 Mar 2009
- Study completion3 Mar 2009
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
- Participant
- Enrolment
- 48 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
- NCT00733577
- Sponsor's protocol ID
- 111829
- Status last verified
- Jul 2017
- First submitted
- 12 Aug 2008
- Last updated
- 13 Jul 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
Hodge RJ, Lin J, Vasist Johnson LS, Gould EP, Bowers GD, Nunez DJ; SB-756050 Project Team. Safety, Pharmacokinetics, and Pharmacodynamic Effects of a Selective TGR5 Agonist, SB-756050, in Type 2 Diabetes. Clin Pharmacol Drug Dev. 2013 Jul;2(3):213-22. doi: 10.1002/cpdd.34. Epub 2013 May 14.
PubMed 27121782
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. 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 Oral SB756050 Administered for 6 Days to Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00733577
- Acronym / sponsor ID
- 111829
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, pharmacodynamics, safety, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2008 (actual)
- Primary completion
- 3 Mar 2009 (actual)
- Study completion
- 3 Mar 2009 (actual)
- First posted
- 13 Aug 2008 (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 is an escalating dose study in subjects with T2DM, which will consist of four overlapping cohorts receiving 6 days of SB756050 to assess safety, pharmacokinetics, and pharmacodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SB75605015 mg SB756050 or placebo |
| Cohort 2 | Experimental | Drug: SB756050Planned dose for Cohorts 2 50mg SB756050 or placebo |
| Cohort 3 | Experimental | Drug: SB756050Planned dose for Cohort 3 150mg SB756050 or placebo |
| Cohort 4 | Experimental | Drug: SB756050Planned dose for Cohort 4 600mg SB756050 or placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female subjects, 18 - 60 years of age, inclusive, at the time of signing the informed consent
- A female subject is eligible to participate if she is of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. FSH and estradiol levels will be checked at Screening for postmenopausal women. Simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory.
- Except as noted elsewhere, subjects should have no significant known medical conditions other than T2DM, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters that meets exclusion criteria but is outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- BMI (body mass index) within the range 25-35 kg/m2, inclusive.
- T2DM diagnosed at least 3 months prior to Screening
Key exclusion criteria (16 listed)
- Has positive pre-study Hepatitis B surface antigen or positive Hepatitis C, result within 3 months of screening. Positive test for HIV antibody. History of uncorrected thyroid dysfunction. ALT and/or AST > 2 times the upper limit of normal at screening. Fasting triglycerides > 450mg/dL at screening. Total Bilirubin > 1.5 times the upper limit of normal at screening. A positive pre-study drug/urine screen and tobacco screen.
- Significant renal disease
- Significant ECG abnormalities
- Systolic pressure > 150 mmHg or <80 mmHg or diastolic blood pressure > 95 mmHg or <60 mmHg at screening.
- Previous use of insulin as a treatment within 3 months of Screening, or for >2 weeks when used for acute illness in the last 12 months prior to Screening, or if used for more than 1 year when associated with GDM.
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 |
|---|---|---|
| SB756050doses are planned to be 15mg to 600mg doses may be altered based on plasma concentrations | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Safety measures including: AEs daily; laboratory testing: day -1,2,5,7 and follow up; ECG: day -1, 2, 5, 6, 7 and follow-up; vital signs: daily; PK parameters day -1,5, and 6.
Time frame: 6 days of dosing
3 secondary outcomes
Pharmacodynamic endpoints will include fasting and meal or OGTT-related weighted mean AUC for glucose, GLP-1 (total and active), glucagon, insulin, PYY (active) and C-peptide levels.
Time frame: 6 days of dosing
Safety and tolerability parameters including adverse events, clinical laboratory, ECGs and vital signs assessments.
Time frame: 6 days of dosing
Subject reports of hunger and craving as reported on the Hunger and Craving questionnaire
Time frame: 6 days of dosing
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 13 Jul 2017.
- Derived from this study: PubMed 27121782Hodge RJ, Lin J, Vasist Johnson LS, Gould EP, Bowers GD, Nunez DJ; SB-756050 Project Team. Safety, Pharmacokinetics, and Pharmacodynamic Effects of a Selective TGR5 Agonist, SB-756050, in Type 2 Diabetes. Clin Pharmacol Drug Dev. 2013 Jul;2(3):213-22. doi: 10.1002/cpdd.34. Epub 2013 May 14.
- Results for study 111829 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
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 SB756050 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 7 inclusion and 16 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 13 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 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. 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?
Safety measures including: AEs daily; laboratory testing: day -1,2,5,7 and follow up; ECG: day -1, 2, 5, 6, 7 and follow-up; vital signs: daily; PK parameters day -1,5, and 6. (time frame: 6 days of dosing). 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 NCT00733577, 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 13 Jul 2017.