Type II Diabetes MellitusPhase 2NCT00929539
Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
A Phase 2 study testing JTT-130 in people with Type II Diabetes Mellitus, run by Shionogi Inc. at 62 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- JTT-130
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 496 participants
- Where
- 62 sitesin 5 countries
- Study dates
- Jun 2009to Jul 2010
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type 2 diabetes;
- Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2;
- Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.
Who cannot join
- Females who are pregnant or breast-feeding
- Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet medication restriction criteria, as described in the protocol.
Trial locations and contacts
62 sites in 5 countries.
62 sites in 5 countries
United States48 sites
Study site
Austin, Texas
Study site
Bellevue, Washington
Study site
Birmingham, Alabama
Study site
Bristol, Tennessee
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
Delray Beach, Florida
Study site
Encino, California
Study site
Erlanger, Kentucky
Study site
Eugene, Oregon
Study site
Greensboro, North Carolina
Study site
Greer, South Carolina
Study site
Hialeah, Florida
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Madisonville, Kentucky
Study site
Manassas, Virginia
Study site
Marion, Ohio
Study site
Miami, Florida
Study site
Morehead City, North Carolina
Study site
Muscle Shoals, Alabama
Study site
New Hyde Park, New York
Study site
New Port Richey, Florida
Study site
North Charleston, South Carolina
Study site
Ocala, Florida
Study site
Olympia, Washington
Study site
Oregon, Wisconsin
Study site
Paducah, Kentucky
Study site
Portland, Oregon
Study site
Richmond, Virginia
Study site
Sacramento, California
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Sandy Springs, Georgia
Study site
Scottsboro, Alabama
Study site
Spring Valley, California
Study site
Statesville, North Carolina
Study site
Tucson, Arizona
Study site
Tulsa, Oklahoma
Study site
Valley Village, California
Study site
Walnut Creek, California
Study site
Waterbury, Connecticut
Czechia6 sites
Study site
Beroun
Study site
Brno
Study site
Ostrava
Study site
Pardubice
Study site
Prague
Study site
Velké Hoštice
Russia4 sites
Study site
Arkhangelsk
Study site
Moscow
Study site
Nizhny Novgorod
Study site
Saint Petersburg
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients
The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- JTT-130, JTT-130 Placebo
- Keywords
- 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.
JTT-130Drug
Tablets
JTT-130 PlaceboDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 JTT-130 | Experimental | Not described Receives: Drug: JTT-130 |
| Dose 2 JTT-130 | Experimental | Not described Receives: Drug: JTT-130 |
| Dose 3 JTT-130 | Experimental | Not described Receives: Drug: JTT-130 |
| Placebo | Placebo comparator | Not described Receives: Drug: JTT-130 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated hemoglobin (HbA1c) levels
Measured: End of Study
Secondary outcomes (1)
Safety and tolerability data
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929539
- Sponsor's protocol ID
- AT130-G-08-006
- Status last verified
- Jan 2013
- First submitted
- 26 Jun 2009
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of JTT-130 in Treatment-naïve, Metformin Only or Metformin Plus Sulfonylurea-treated Obese Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00929539
- Acronym / sponsor ID
- AT130-G-08-006
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Jun 2009 (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 purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 JTT-130 | Experimental | Drug: JTT-130 |
| Dose 2 JTT-130 | Experimental | Drug: JTT-130 |
| Dose 3 JTT-130 | Experimental | Drug: JTT-130 |
| Placebo | Placebo comparator | Drug: JTT-130 Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have type 2 diabetes;
- Body mass index (BMI) of > 27.0 kg/m2 and ≤ 45.0 kg/m2;
- Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.
Key exclusion criteria (4 listed)
- Females who are pregnant or breast-feeding
- Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet medication restriction criteria, as described in the protocol.
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 |
|---|---|---|
| JTT-130Tablets | Drug | Dose 1 JTT-130, Dose 2 JTT-130, Dose 3 JTT-130 |
| JTT-130 PlaceboTablets | Drug | Placebo |
Primary outcome
Change in glycosylated hemoglobin (HbA1c) levels
Time frame: End of Study
1 secondary outcome
Safety and tolerability data
Time frame: End of Study
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 4 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JTT-130 in people with Type II Diabetes Mellitus, run by Shionogi Inc. at 62 sites in 5 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 3 inclusion and 4 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 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Czechia, Russia, Hungary, Netherlands. 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 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?
Change in glycosylated hemoglobin (HbA1c) levels (time frame: End 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 4 Feb 2013.