Diabetes Mellitus, Type 2Phase 2NCT00291356
GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients
A Phase 2 study testing GSK189075 oral tablets and GW869682 oral tablets in people with Diabetes Mellitus, Type 2 and Non-Insulin-Dependent Diabetes Mellitus, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
This is a study to compare the safety, blood concentrations, and effects of GSK189075, GW869682, and placebo when dosed for 2-weeks by mouth to patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Non-Insulin-Dependent Diabetes Mellitus
- What is being tested?
- GSK189075 oral tablets and GW869682 oral tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2006to May 2006
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes.
- HbA1c (a measure of the average amount of sugar in blood over the last 2 or 3 months) levels are between 7.0 and 9.0.
- Taking 850mg or more per day metformin, but not taking any other diabetes medications.
- Must be medically able and willing to discontinue diabetic medications from at least 2 weeks prior to first study dose until the last study assessment.
- Diabetic subjects who have not yet started taking diabetes medications or whose diabetes is controlled by diet alone may also be eligible to enroll if their HbA1c is within 7.5 to 9.0.
- Women may be eligible if they are post-menopausal or surgically sterile.
- If taking ACE inhibitors, beta-blockers, calcium channel blockers, or statin type drugs, you may be eligible if your dose has been stable for at least 30 days prior to the start of the clinical trial.
Who cannot join
- Using illicit drugs, or have antibodies to hepatitis B, hepatitis C, or HIV.
- Have any major health problems other than type 2 diabetes.
- Require insulin therapy or oral antidiabetic medication other than metformin.
- Subjects who have had a urinary tract infection within 4 weeks of the start of the study or who have kidney disease.
- Subjects with either low or high blood pressure.
- Men who are unwilling to abstain from intercourse, or use a condom with a pregnant or nursing female, or who are unwilling to use a condom with another form of contraception with a female who could become pregnant.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
GSK Investigational Site
Berlin, State of Berlin, 14050
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41460
United States1 site
GSK Investigational Site
Chula Vista, California, 91910
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Repeat Dose Study to Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK189075 With GW869682 in Subjects With Type 2 Diabetes Mellitus
This is a study to compare the safety, blood concentrations, and effects of GSK189075, GW869682, and placebo when dosed for 2-weeks by mouth to patients with type 2 diabetes.
- Being tested
- GSK189075 oral tablets, GW869682 oral tablets
- Keywords
- Diabetes, sodium dependent glucose transporter, SGLT2, GSK189075, GSK189074, SGLT1, GW869683
- 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.
GSK189075 oral tabletsDrug
GW869682 oral tabletsDrug
Also called GSK189075 oral tablets
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: side effects and relevant changes in blood pressure, heart rate and ECG measurements, blood and urine measurements, the amount of fluid taken in and excreted, and kidney function will be monitored over course of study.
Secondary outcomes (1)
Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 45 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
- NCT00291356
- Sponsor's protocol ID
- KG2104940
- Status last verified
- Apr 2015
- First submitted
- 13 Feb 2006
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Repeat Dose Study to Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK189075 With GW869682 in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00291356
- Acronym / sponsor ID
- KG2104940
- Keywords
- Diabetes, sodium dependent glucose transporter, SGLT2, GSK189075, GSK189074, SGLT1, GW869683
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 14 Feb 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 is a study to compare the safety, blood concentrations, and effects of GSK189075, GW869682, and placebo when dosed for 2-weeks by mouth to patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 diabetes.
- HbA1c (a measure of the average amount of sugar in blood over the last 2 or 3 months) levels are between 7.0 and 9.0.
- Taking 850mg or more per day metformin, but not taking any other diabetes medications.
- Must be medically able and willing to discontinue diabetic medications from at least 2 weeks prior to first study dose until the last study assessment.
- Diabetic subjects who have not yet started taking diabetes medications or whose diabetes is controlled by diet alone may also be eligible to enroll if their HbA1c is within 7.5 to 9.0.
Key exclusion criteria (6 listed)
- Using illicit drugs, or have antibodies to hepatitis B, hepatitis C, or HIV.
- Have any major health problems other than type 2 diabetes.
- Require insulin therapy or oral antidiabetic medication other than metformin.
- Subjects who have had a urinary tract infection within 4 weeks of the start of the study or who have kidney disease.
- Subjects with either low or high blood pressure.
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 |
|---|---|---|
| GSK189075 oral tablets | Drug | – |
| GW869682 oral tabletsAlso: GSK189075 oral tablets | Drug | – |
Primary outcome
Safety and tolerability: side effects and relevant changes in blood pressure, heart rate and ECG measurements, blood and urine measurements, the amount of fluid taken in and excreted, and kidney function will be monitored over course of study.
1 secondary outcome
Amount and percentage of glucose excreted in urine by kidneys. Effect of compounds on lipid metabolism analysed.
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 15 Apr 2015.
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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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK189075 oral tablets and GW869682 oral tablets in people with Diabetes Mellitus, Type 2 and Non-Insulin-Dependent Diabetes Mellitus, run by GlaxoSmithKline at 3 sites in 2 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 7 inclusion and 6 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 and tolerability: side effects and relevant changes in blood pressure, heart rate and ECG measurements, blood and urine measurements, the amount of fluid taken in and excreted, and kidney function will be monitored over course of study.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2015.