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Type 2 Diabetes MellitusPhase 2NCT01699737

Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus

A Phase 2 study testing JTT-851 and Glimepiride in people with Type 2 Diabetes Mellitus, run by Shionogi Inc. at 79 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
JTT-851 and Glimepiride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
325 participants
Where
79 sitesUnited States
Study dates
Sep 2012to Jul 2013
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

  • Males and females with type 2 diabetes, 18-70 years of age at Visit 1
  • Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
  • Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
  • Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1

Who cannot join

  • Females who are pregnant or breast-feeding
  • Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
  • Acute coronary syndrome or uncontrolled hypertension
  • Does not meet all diet or previous/concomitant medication restriction criteria

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

United States79 sites

  • Study site

    Artesia, California

  • Study site

    Berlin, New Jersey

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Buena Park, California

  • Study site

    Burke, Virginia

  • Study site

    Carrollton, Texas

  • Study site

    Chicago, Illinois

  • Study site

    Chino, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Cooper City, Florida

  • Study site

    Corpus Christi, Texas

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Dothan, Alabama

  • Study site

    Eugene, Oregon

  • Study site

    Evanston, Illinois

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Garden Grove, California

  • Study site

    Glen Falls, New York

  • Study site

    Glendale, Arizona

  • Study site

    Greensboro, North Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Hialeah, Florida

  • Study site

    Houston, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Kettering, Ohio

  • Study site

    Kissimee, Florida

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, California

  • Study site

    Little Rock, Arkansas

  • Study site

    Lomita, California

  • Study site

    Los Angeles, California

  • Study site

    Madison, Wisconsin

  • Study site

    Manassas, Virginia

  • Study site

    Marietta, Georgia

  • Study site

    Marion, Ohio

  • Study site

    Miami, Florida

  • Study site

    Mine Hill, New Jersey

  • Study site

    Miramar, Florida

  • Study site

    Montgomery, Alabama

  • Study site

    Munroe Falls, Ohio

  • Study site

    Murray, Utah

  • Study site

    Muscle Shoals, Alabama

  • Study site

    Nampa, Idaho

  • Study site

    New Orleans, Louisiana

  • Study site

    Newport Beach, California

  • Study site

    Norfolk, Virginia

  • Study site

    Norman, Oklahoma

  • Study site

    North Hollywood, California

  • Study site

    Ocala, Florida

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Orem, Utah

  • Study site

    Orlando, Florida

  • Study site

    Ormond Beach, Florida

  • Study site

    Oxon Hill, Maryland

  • Study site

    Paramount, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Plano, Texas

  • Study site

    Port Orange, Florida

  • Study site

    Portland, Oregon

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Spring Valley, California

  • Study site

    Suffolk, Virginia

  • Study site

    Sugarland, Texas

  • Study site

    Tampa, Florida

  • Study site

    Tomball, Texas

  • Study site

    Tucson, Arizona

  • Study site

    Wadsworth, Ohio

  • Study site

    Walnut Creek, California

  • Study site

    Wichita, Kansas

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

Read the detailed description

This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

Being tested
JTT-851, Glimepiride, Placebo for Active, Placebo for comparator
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-851Drug

  • GlimepirideDrug

    Encapsulated Glimepiride tablets

  • Placebo for ActiveDrug

  • Placebo for comparatorDrug

Study groups in NCT01699737
Study groupRoleWhat they receive
JTT-851 Dose 1ExperimentalJTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Receives: Drug: JTT-851; Drug: Placebo for comparator
JTT-851 Dose 2ExperimentalJTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Receives: Drug: JTT-851; Drug: Placebo for comparator
JTT-851 Dose 3ExperimentalJTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks
Receives: Drug: JTT-851; Drug: Placebo for comparator
Glimepiride Dose 1Active comparatorActive Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks
Receives: Drug: Glimepiride; Drug: Placebo for Active
Placebo active & Placebo comparatorPlacebo comparatorPlacebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks
Receives: Drug: Placebo for Active; Drug: Placebo for comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851

    To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks

    Measured: 12 weeks

Secondary outcomes (3)

  1. Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo

    To evaluate the safety and tolerability of JTT-851 when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo.

    Measured: 12 weeks

  2. Effect on ancillary efficacy measures

    To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.

    Measured: 12 weeks

  3. Pharmacokinetics of JTT-851 and its metabolites

    To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionMay 2013
  4. Study completionJul 2013

Resources

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
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01699737
Sponsor's protocol ID
AT851-U-12-002
Status last verified
Jul 2013
First submitted
2 Oct 2012
Last updated
1 Aug 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JTT-851 and Glimepiride in people with Type 2 Diabetes Mellitus, run by Shionogi Inc. at 79 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 4 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 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 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 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) after administration of JTT-851 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01699737.

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 1 Aug 2013.

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