Type II Diabetes MellitusPhase 2NCT00997152
Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
A Phase 2 study testing JTT-654 in people with Type II Diabetes Mellitus, run by Shionogi Inc. at 42 sites in United States.
Trial summary
The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in 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-654
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 42 sitesUnited States
- Study dates
- Sep 2009to Apr 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 ≤ 45.0 kg/m2;
- Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.
Who cannot join
- Females who are pregnant or breast-feeding;
- Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet all diet or previous/concomitant medication restrictions criteria, as described in the protocol.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Study site
Addison, Illinois
Study site
Birmingham, Alabama
Study site
Bristol, Tennessee
Study site
Carrollton, Texas
Study site
Chandler, Arizona
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Chino, California
Study site
Cincinnati, Ohio
Study site
Corpus Christi, Texas
Study site
Dallas, Texas
Study site
DeLand, Florida
Study site
Great Falls, Montana
Study site
Greenbrae, California
Study site
Hialeah, Florida
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Huntington Park, California
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Katy, Texas
Study site
Lansdale, Pennsylvania
Study site
Los Angeles, California
Study site
Marietta, Georgia
Study site
Marion, Ohio
Study site
Miami, Florida
Study site
Morehead City, North Carolina
Study site
New Bedford, Massachusetts
Study site
Norfolk, Virginia
Study site
Oklahoma City, Oklahoma
Study site
Oxon Hill, Maryland
Study site
Paramount, California
Study site
Phoenix, Arizona
Study site
Port Orange, Florida
Study site
Richmond, Virginia
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
Sugar Land, Texas
Study site
Tempe, Arizona
Study site
Virginia Beach, Virginia
Study site
Walnut Creek, California
Study site
West Covina, California
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-controlled, Multi-Center, Parallel Group Study Evaluating the Efficacy, Safety and Pharmacokinetics of JTT-654 Administered for 12 Weeks in Untreated or Metformin-treated Type 2 Diabetic Patients
The purpose of this study is to evaluate the effect of JTT-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in type 2 diabetic patients.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- JTT-654, JTT-654 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-654Drug
Tablets
JTT-654 PlaceboDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 JTT-654 | Experimental | Not described Receives: Drug: JTT-654 |
| Dose 2 JTT-654 | Experimental | Not described Receives: Drug: JTT-654 |
| Placebo | Placebo comparator | Not described Receives: Drug: JTT-654 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fasting Plasma Glucose (FPG) levels
Measured: 3 months
Secondary outcomes (3)
Change in glycosylated hemoglobin (HbA1c) levels
Measured: 3 months
Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters
Measured: 3 months
Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionApr 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
- 152 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
- NCT00997152
- Sponsor's protocol ID
- AT654-U-09-004
- Status last verified
- Jan 2013
- First submitted
- 14 Oct 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, Multi-Center, Parallel Group Study Evaluating the Efficacy, Safety and Pharmacokinetics of JTT-654 Administered for 12 Weeks in Untreated or Metformin-treated Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00997152
- Acronym / sponsor ID
- AT654-U-09-004
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 Oct 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-654 on diabetes as well as the safety, tolerability and pharmacokinetics of JTT-654 in 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 JTT-654 | Experimental | Drug: JTT-654 |
| Dose 2 JTT-654 | Experimental | Drug: JTT-654 |
| Placebo | Placebo comparator | Drug: JTT-654 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 ≤ 45.0 kg/m2;
- Are either untreated with respect to hypoglycemic agents OR are currently being treated with a stable dose of metformin alone.
Key exclusion criteria (4 listed)
- Females who are pregnant or breast-feeding;
- Known medical history or presence of type 1 diabetes or pancreatitis, acute metabolic diabetic complications, presence of unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
- Acute coronary syndrome or uncontrolled hypertension;
- Does not meet all diet or previous/concomitant medication restrictions 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-654Tablets | Drug | Dose 1 JTT-654, Dose 2 JTT-654 |
| JTT-654 PlaceboTablets | Drug | Placebo |
Primary outcome
Change in Fasting Plasma Glucose (FPG) levels
Time frame: 3 months
3 secondary outcomes
Change in glycosylated hemoglobin (HbA1c) levels
Time frame: 3 months
Effect on glycated albumin, insulin, C-peptide, glucagon and lipid parameters
Time frame: 3 months
Safety (biochemistry, hematology, urinalysis and adrenal-related markers) and tolerability (adverse events)
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
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.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JTT-654 in people with Type II Diabetes Mellitus, run by Shionogi Inc. at 42 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 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: stopped early, 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 42 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. 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 was stopped early. Results are not available in the source record.
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 Fasting Plasma Glucose (FPG) levels (time frame: 3 months). 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.