Type 2 Diabetes MellitusPhase 2/3NCT00387972
Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)
A Phase 2/3 study testing denagliptin (GW823093) in people with Type 2 Diabetes Mellitus, run by GlaxoSmithKline at 57 sites in United States.
Trial summary
GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- denagliptin (GW823093)
- How many people
- 0 participants
- Where
- 57 sitesUnited States
- Study dates
- May 2006to Oct 2007
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment
- Body mass index between 20 and 40
- Females of childbearing potential must use adequate birth control.
Who cannot join
- Subjects with previous use of insulin
- Type 1 diabetes
- Uncontrolled thyroid disease
- History of drug or alcohol abuse in the past year
- Any other clinically significant disease.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
GSK Clinical Trials Call Center
Anderson, South Carolina, 29621
GSK Clinical Trials Call Center
Baton Rouge, Louisiana, 70809
GSK Clinical Trials Call Center
Beaver Falls, Pennsylvania, 15010
GSK Clinical Trials Call Center
Beverly Hills, California, 90211
GSK Clinical Trials Call Center
Boynton Beach, Florida, 33435
GSK Clinical Trials Call Center
Calhoun, Georgia, 30701
GSK Clinical Trials Call Center
Carmichael, California, 95608
GSK Clinical Trials Call Center
Charlotte, North Carolina, 28277
GSK Clinical Trials Call Center
Chattanooga, Tennessee, 37404
GSK Clinical Trials Call Center
Chicago, Illinois, 60610
GSK Clinical Trials Call Center
Chicago, Illinois, 60616
GSK Clinical Trials Call Center
Cincinnati, Ohio, 45219
GSK Clinical Trials Call Center
City of Saint Peters, Missouri, 63376
GSK Clinical Trials Call Center
Clearwater, Florida, 33765
GSK Clinical Trials Call Center
Cleburne, Texas, 76033
GSK Clinical Trials Call Center
Columbus, Ohio, 43207
GSK Clinical Trials Call Center
Concord, California, 94520-2054
GSK Clinical Trials Call Center
Coral Gables, Florida, 33134
GSK Clinical Trials Call Center
Detroit, Michigan, 48235
GSK Clinical Trials Call Center
Eugene, Oregon, 97404
GSK Clinical Trials Call Center
Fargo, North Dakota, 58103
GSK Clinical Trials Call Center
Fleetwood, Pennsylvania, 19522
GSK Clinical Trials Call Center
Florissant, Missouri, 63031
GSK Clinical Trials Call Center
Guthrie, Oklahoma, 73044
GSK Clinical Trials Call Center
Hayden Lake, Idaho, 83835-2108
GSK Clinical Trials Call Center
Hialeah, Florida, 33010
GSK Clinical Trials Call Center
Hollywood, Florida, 33023
GSK Clinical Trials Call Center
Johnson City, Tennessee, 37601
GSK Clinical Trials Call Center
Lake Zurich, Illinois, 60047
GSK Clinical Trials Call Center
Las Vegas, Nevada, 89128
GSK Clinical Trials Call Center
Marrero, Louisiana, 70072
GSK Clinical Trials Call Center
Medford, Oregon, 97504
GSK Clinical Trials Call Center
Melbourne, Florida, 32901
GSK Clinical Trials Call Center
Miami, Florida, 33169
GSK Clinical Trials Call Center
Morehead City, North Carolina, 28557
GSK Clinical Trials Call Center
Norman, Oklahoma, 73069
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, 73112-5550
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, 73116
GSK Clinical Trials Call Center
Opa-locka, Florida, 33054
GSK Clinical Trials Call Center
Oxon Hill, Maryland, 20745
GSK Clinical Trials Call Center
Phoenix, Arizona, 85016
GSK Clinical Trials Call Center
Plantation, Florida, 33324
GSK Clinical Trials Call Center
Roswell, Georgia, 30076
GSK Clinical Trials Call Center
San Antonio, Texas, 78205
GSK Clinical Trials Call Center
Seguin, Texas, 78155
GSK Clinical Trials Call Center
St Louis, Missouri, 63128
GSK Clinical Trials Call Center
Tallassee, Alabama, 36078
GSK Clinical Trials Call Center
Tampa, Florida, 33609
GSK Clinical Trials Call Center
Torrance, California, 90505
GSK Clinical Trials Call Center
Tucson, Arizona, 85710
GSK Clinical Trials Call Center
Victorville, California, 92392
GSK Clinical Trials Call Center
Warminster, Pennsylvania, 18974
GSK Clinical Trials Call Center
Watseka, Illinois, 60970
GSK Clinical Trials Call Center
Weber City, Virginia, 24290
GSK Clinical Trials Call Center
Williamsville, New York, 14221
GSK Clinical Trials Call Center
Wilmington, Delaware, 19805
GSK Clinical Trials Call Center
Yukon, Oklahoma, 73112
About this study
Official title: A Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Denagliptin in Subjects With Type 2 Diabetes Mellitus
GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- denagliptin (GW823093)
- Keywords
- Type 2 diabetes mellitus (T2DM), glycosylated hemoglobin (HbA1c), denagliptin, diabetes treatment, glycemic control
- 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.
denagliptin (GW823093)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood glucose regulation after 26 weeks of treatment
Secondary outcomes (1)
Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2007 (estimated)
- Study completionOct 2007 (estimated)
Why it stopped: Study cancelled before enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trial, DM, FRCP, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387972
- Sponsor's protocol ID
- DPB107246
- Status last verified
- Apr 2015
- First submitted
- 12 Oct 2006
- Last updated
- 17 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Denagliptin in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00387972
- Acronym / sponsor ID
- DPB107246
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus (T2DM), glycosylated hemoglobin (HbA1c), denagliptin, diabetes treatment, glycemic control
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled before enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2007 (estimated)
- Study completion
- Oct 2007 (estimated)
- First posted
- 13 Oct 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.
GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment
- Body mass index between 20 and 40
- Females of childbearing potential must use adequate birth control.
Key exclusion criteria (5 listed)
- Subjects with previous use of insulin
- Type 1 diabetes
- Uncontrolled thyroid disease
- History of drug or alcohol abuse in the past year
- Any other clinically significant disease.
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 |
|---|---|---|
| denagliptin (GW823093) | Drug | – |
Primary outcome
Change from baseline in blood glucose regulation after 26 weeks of treatment
1 secondary outcome
Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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 Trial, DM, FRCP study director
GlaxoSmithKline
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing denagliptin (GW823093) in people with Type 2 Diabetes Mellitus, run by GlaxoSmithKline at 57 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 17 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 57 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in blood glucose regulation after 26 weeks of treatment. 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 17 Apr 2015.