Diabetes Mellitus, Type 2Phase 1NCT00494767
Investigation Of Weight Loss And Body Composition Changes After Dosing With Either Placebo Or One Of Two Active Drugs
A Phase 1 study testing GW869682 and GSK189075 in people with Diabetes Mellitus, Type 2 and Obesity, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The drugs GSK189075 and GW869682 result in increased caloric losses. This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body. The body composition (fat,water, lean mass) is determined using a new investigational MR technology. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- GW869682 and GSK189075
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2006to 7 Jun 2007
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 30 - 40kg/m
- Females may be included if they are surgically sterile or post-menopausal
Who cannot join
- Change in body weight >4% in the last 3 months
- History of eating disorders
- had bariatric surgical intervention for obesity
- have type I or II diabetes
- Thyroid disorder not under control
- Renal or hepatobiliary disease
Show all 9Show fewer
- Excessive alcohol consumption
- Use of drugs of abuse
- donated of blood in the last 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2GG
About this study
Official title: An Exploratory Study to Evaluate Weight Loss, Body Composition Changes, Food Intake and Urine Glucose Excretion in Healthy Obese Subjects Over 8 Weeks of Dosing With GSK189075, GW869682 Versus Placebo
The drugs GSK189075 and GW869682 result in increased caloric losses. This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body. The body composition (fat,water, lean mass) is determined using a new investigational MR technology.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- GW869682, GSK189075, GSK189075-Placebo, GW869682-Placebo
- Keywords
- body composition, obesity, 4C model, hunger, weight loss
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW869682Drug
GW869682 tablet with a dose strength of 250 mg will be available for subjects
GSK189075Drug
Also called GW869682
GSK189075 tablet with a dose strength of 250 mg will be available for subjects
GSK189075-PlaceboDrug
Placebo tablets to match GSK189075 250 mg will be available for subjects
GW869682-PlaceboDrug
Placebo tablets to match GW869682 250 mg will be available for subjects
| Study group | Role | What they receive |
|---|---|---|
| GW869682 1000 mg thrice daily (TID) | Experimental | Subjects will be randomized to receive GW869682 1000 mg TID Receives: Drug: GW869682; Drug: GSK189075; Drug: GSK189075-Placebo; Drug: GW869682-Placebo |
| GSK189075 250 mg TID | Experimental | Subjects will be randomized to receive GSK189075 250 mg TID Receives: Drug: GW869682; Drug: GSK189075; Drug: GSK189075-Placebo; Drug: GW869682-Placebo |
| GW869682-Placebo TID | Placebo comparator | Subjects will be randomized to receive Placebo matching GW869682 for TID Receives: Drug: GW869682; Drug: GSK189075; Drug: GSK189075-Placebo; Drug: GW869682-Placebo |
| GSK189075-Placebo TID | Placebo comparator | Subjects will be randomized to receive Placebo matching GSK189075 for TID Receives: Drug: GW869682; Drug: GSK189075; Drug: GSK189075-Placebo; Drug: GW869682-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies.
Measured: Measurements at week 8 will be compared to measurements from Day -1
Secondary outcomes (3)
Safety (caloric losses body weight, body composition, weight and hip circumference.)
Measured: throughout study (Days 1-56)
Leptin levels in serum
Measured: at several points during study
Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study start29 Sep 2006
- Primary completion7 Jun 2007
- Study completion7 Jun 2007
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 27 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
- NCT00494767
- Sponsor's protocol ID
- KGW108201
- Status last verified
- Aug 2017
- First submitted
- 31 Oct 2006
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate Weight Loss, Body Composition Changes, Food Intake and Urine Glucose Excretion in Healthy Obese Subjects Over 8 Weeks of Dosing With GSK189075, GW869682 Versus Placebo
- ClinicalTrials.gov ID
- NCT00494767
- Acronym / sponsor ID
- KGW108201
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- body composition, obesity, 4C model, hunger, weight loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2006 (actual)
- Primary completion
- 7 Jun 2007 (actual)
- Study completion
- 7 Jun 2007 (actual)
- First posted
- 2 Jul 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.
The drugs GSK189075 and GW869682 result in increased caloric losses. This study is investigating how if taken over 8 weeks that affects weight loss, food intake and the composition of the body. The body composition (fat,water, lean mass) is determined using a new investigational MR technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GW869682 1000 mg thrice daily (TID) | Experimental | Drug: GW869682, Drug: GSK189075, Drug: GSK189075-Placebo, Drug: GW869682-PlaceboSubjects will be randomized to receive GW869682 1000 mg TID |
| GSK189075 250 mg TID | Experimental | Drug: GW869682, Drug: GSK189075, Drug: GSK189075-Placebo, Drug: GW869682-PlaceboSubjects will be randomized to receive GSK189075 250 mg TID |
| GW869682-Placebo TID | Placebo comparator | Drug: GW869682, Drug: GSK189075, Drug: GSK189075-Placebo, Drug: GW869682-PlaceboSubjects will be randomized to receive Placebo matching GW869682 for TID |
| GSK189075-Placebo TID | Placebo comparator | Drug: GW869682, Drug: GSK189075, Drug: GSK189075-Placebo, Drug: GW869682-PlaceboSubjects will be randomized to receive Placebo matching GSK189075 for TID |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI of 30 - 40kg/m
- Females may be included if they are surgically sterile or post-menopausal
Key exclusion criteria (9 listed)
- Change in body weight >4% in the last 3 months
- History of eating disorders
- had bariatric surgical intervention for obesity
- have type I or II diabetes
- Thyroid disorder not under control
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 |
|---|---|---|
| GW869682GW869682 tablet with a dose strength of 250 mg will be available for subjects | Drug | GSK189075 250 mg TID, GSK189075-Placebo TID, GW869682 1000 mg thrice daily (TID), GW869682-Placebo TID |
| GSK189075Also: GW869682GSK189075 tablet with a dose strength of 250 mg will be available for subjects | Drug | GSK189075 250 mg TID, GSK189075-Placebo TID, GW869682 1000 mg thrice daily (TID), GW869682-Placebo TID |
| GSK189075-PlaceboPlacebo tablets to match GSK189075 250 mg will be available for subjects | Drug | GSK189075 250 mg TID, GSK189075-Placebo TID, GW869682 1000 mg thrice daily (TID), GW869682-Placebo TID |
| GW869682-PlaceboPlacebo tablets to match GW869682 250 mg will be available for subjects | Drug | GSK189075 250 mg TID, GSK189075-Placebo TID, GW869682 1000 mg thrice daily (TID), GW869682-Placebo TID |
Primary outcome
Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies.
Time frame: Measurements at week 8 will be compared to measurements from Day -1
3 secondary outcomes
Safety (caloric losses body weight, body composition, weight and hip circumference.)
Time frame: throughout study (Days 1-56)
Leptin levels in serum
Time frame: at several points during study
Drug levels in blood over time (Day 42 PK parameters are AUC, Cmax, tmax)
Time frame: Day 42
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 7 Aug 2017.
- Results for study KGW108201 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
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 GW869682 and GSK189075 in people with Diabetes Mellitus, Type 2 and Obesity, run by GlaxoSmithKline at 1 site in United Kingdom.
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 9 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 7 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 Kingdom. 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?
Body fat and fat-free mass as determined by a new investigational MR technique compared to 4C Model methodologies. (time frame: Measurements at week 8 will be compared to measurements from Day -1). 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 7 Aug 2017.