Diabetes Mellitus, Type 2Phase 1NCT00519480
A Study To Assess The Safety And Tolerability Of GSK189075 When Given With A Total Daily Dose Of >/ 2000mg of Metformin
A Phase 1 study testing GSK189075 and Metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 4 sites in 3 countries.
Trial summary
This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- GSK189075 and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 11 Sep 2007to 1 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 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Type 2 Diabetes for at least three months prior to study
- Diabetes treated with metformin only
- Give consent and sign an informed consent form.
- Agree to follow specific requirements of birth control during participation.
Who cannot join
- Type I Diabetes.
- Treatment with insulin within 3 months prior to screening
- History of diabetic ketoacidosis or lactic acidosis
- Allergy or sensitivity to metformin or similar drugs or any medical conditions which prohibit metformin use
- Excessive blood donation 56 days before the start of the study
- Urinary tract or bladder infections within four weeks of study start
Show all 10Show fewer
- Alcohol abuse or illicit drug use within 12 months of study start
- Receiving other investigational drugs or participating in other research trials within 30 of the study start
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements with 7-14 days of study start
- Live alone without regular, daily interactions with someone who can be an emergency contact
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
GSK Investigational Site
Miami, Florida, 33169
GSK Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A Two-Week, Randomized, Double-Blind, Repeat-Dose, Parallel-Group Study to Evaluate the Safety and Tolerability of Metformin > 2000mg Co-Administered With Either GSK189075 500mg BID or GSK 189075 750mg BID to Subjects With Type 2 Diabetes Mellitus
This study will assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GSK189075, Metformin, Placebo
- Keywords
- Tolerability, GSK189075,, Metformin,, Safety,, Diabetes,
- 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.
GSK189075Drug
GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams.
MetforminDrug
Metformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams.
PlaceboDrug
Placebo will be available as an oral tablets.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving treatment P | Placebo comparator | Eligible subjects will receive placebo twice daily along with metformin twice daily for 13 days. Receives: Drug: Metformin; Drug: Placebo |
| Subjects receiving treatment A | Experimental | Eligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days. Receives: Drug: GSK189075; Drug: Metformin |
| Subjects receiving treatment B | Experimental | Eligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days. Receives: Drug: GSK189075; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical laboratory tests, ECGs, physical exam & adverse events:
Measured: screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days)
Home diary of blood sugar results, adverse events and drug dosing.
Measured: throughout the study (approximately 50 days)
Secondary outcomes (3)
study drug blood levels:
Measured: Dosing Days 1 & 13 metformin blood levels: Days -1 & 13
Blood glucose & insulin levels following oral glucose challenge:
Measured: Dosing Days -1 & 13
fluid intake & output
Measured: dosing Days -1 - 3, 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study start11 Sep 2007
- Primary completion1 Apr 2008
- Study completion1 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 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
- NCT00519480
- Sponsor's protocol ID
- KG2110243
- Status last verified
- Sep 2017
- First submitted
- 20 Aug 2007
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dobbins R, Hussey EK, O'Connor-Semmes R, Andrews S, Tao W, Wilkison WO, Cheatham B, Sagar K, Hanmant B. Assessment of safety and tolerability of remogliflozin etabonate (GSK189075) when administered with total daily dose of 2000 mg of metformin. BMC Pharmacol Toxicol. 2021 Jun 13;22(1):34. doi: 10.1186/s40360-021-00502-0.
PubMed 34120651
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Week, Randomized, Double-Blind, Repeat-Dose, Parallel-Group Study to Evaluate the Safety and Tolerability of Metformin > 2000mg Co-Administered With Either GSK189075 500mg BID or GSK 189075 750mg BID to Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00519480
- Acronym / sponsor ID
- KG2110243
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Tolerability, GSK189075,, Metformin,, Safety,, Diabetes,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2007 (actual)
- Primary completion
- 1 Apr 2008 (actual)
- Study completion
- 1 Apr 2008 (actual)
- First posted
- 22 Aug 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 assess safety and tolerability of metformin plus GSK189075 in people with Type 2 Diabetes. About 48 people will participate in this study. Volunteers will not know if they are receiving GSK189075 or a placebo. Participation will last about 5 weeks including a run-in period of up to 2 weeks if necessary to increase metformin up to 2000mg daily, a 13-day treatment period, and a follow-up visit about 1 week after the treatment period. Volunteers will remain in the research clinic beginning 2 days before they receive the first dose of GSK189075 until after the morning dose on the fourth day and from the afternoon of the 12th day of dosing until the morning after the last dose. They will have clinic visits on dosing Days 6, 8, and 10. Volunteers will be given equipment and instructions for measuring their blood sugar at home and will be asked to keep a study diary. Blood pressure, heart rate, laboratory tests on blood and urine, physical examinations, reports of drug side effects and ECGs will be obtained during the clinic visits to assess safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving treatment P | Placebo comparator | Drug: Metformin, Drug: PlaceboEligible subjects will receive placebo twice daily along with metformin twice daily for 13 days. |
| Subjects receiving treatment A | Experimental | Drug: GSK189075, Drug: MetforminEligible subjects will receive GSK189075 500 milligrams twice daily along with metformin twice daily for 13 days. |
| Subjects receiving treatment B | Experimental | Drug: GSK189075, Drug: MetforminEligible subjects will receive GSK189075 750 milligrams twice daily along with metformin twice daily for 13 days. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with Type 2 Diabetes for at least three months prior to study
- Diabetes treated with metformin only
- Give consent and sign an informed consent form.
- Agree to follow specific requirements of birth control during participation.
Key exclusion criteria (10 listed)
- Type I Diabetes.
- Treatment with insulin within 3 months prior to screening
- History of diabetic ketoacidosis or lactic acidosis
- Allergy or sensitivity to metformin or similar drugs or any medical conditions which prohibit metformin use
- Excessive blood donation 56 days before the start of the 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 |
|---|---|---|
| GSK189075GSK189075 will be available as an oral tablet with dosing strengths of 500 milligrams and 250 milligrams. | Drug | Subjects receiving treatment A, Subjects receiving treatment B |
| MetforminMetformin will be available as an immediate release oral tablet with dosing strengths of 500 milligrams and 850 milligrams. | Drug | Subjects receiving treatment A, Subjects receiving treatment B, Subjects receiving treatment P |
| PlaceboPlacebo will be available as an oral tablets. | Drug | Subjects receiving treatment P |
Primary outcome
Clinical laboratory tests, ECGs, physical exam & adverse events:
Time frame: screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days)
Home diary of blood sugar results, adverse events and drug dosing.
Time frame: throughout the study (approximately 50 days)
3 secondary outcomes
study drug blood levels:
Time frame: Dosing Days 1 & 13 metformin blood levels: Days -1 & 13
Blood glucose & insulin levels following oral glucose challenge:
Time frame: Dosing Days -1 & 13
fluid intake & output
Time frame: dosing Days -1 - 3, 13
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 6 Sep 2017.
- Derived from this study: PubMed 34120651Dobbins R, Hussey EK, O'Connor-Semmes R, Andrews S, Tao W, Wilkison WO, Cheatham B, Sagar K, Hanmant B. Assessment of safety and tolerability of remogliflozin etabonate (GSK189075) when administered with total daily dose of 2000 mg of metformin. BMC Pharmacol Toxicol. 2021 Jun 13;22(1):34. doi: 10.1186/s40360-021-00502-0.
- Results for study KG2110243 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK189075 and Metformin in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 4 sites in 3 countries.
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 4 inclusion and 10 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 6 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 4 sites in United States, Argentina, Germany. 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?
Clinical laboratory tests, ECGs, physical exam & adverse events: (time frame: screening, in-clinic stays, outpatient clinic visits & follow up visit (approximately 50 days)). The study lists 2 primary outcomes in all. 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 NCT00519480, 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 6 Sep 2017.