A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator

August 18, 2010 updated by: InteKrin Therapeutics, Inc.

A Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of INT131 Besylate Compared to Pioglitazone in Subjects With Type 2 Diabetes

This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
367

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Nucleo Medico Vallarta
    • Mexico DF
      • Mexico City, Mexico DF, Mexico, 06100
        • Comite Mexicano para la Prevencion de la Osteoporosis A.C.
      • Mexico City, Mexico DF, Mexico, 11650
        • Centro Especializado en Diabetes y Obisidad (EDOPEC)
      • Mexico City, Mexico DF, Mexico, 14000
        • Instituto Nacional de Nutricion Salvador Zubiran (INNSZ)
      • Mexico City, Mexico DF, Mexico
        • Instituto Mexicano de Investigación Clinica
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • Unidad Metabolica y Cardiovascular SC
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 66220
        • Hospital Santa Engracia
  • United States
    • California
      • Carmichael, California, United States, 95608
        • Northern California Research
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System
      • Santa Ana, California, United States, 92705
        • Apex Research Institute
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Internal Medicine of the Rockies
      • Denver, Colorado, United States, 80209
        • Creekside Endocrine Associates, PC
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • Medstar Research Institute
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Hollywood, Florida, United States, 33021
        • The Center for Diabetes and Endocrine Care
      • Miami, Florida, United States, 33169
        • Elite Research Institute
      • Miami, Florida, United States, 33156
        • Baptist Diabetes Associates, PA
      • Miami, Florida, United States, 33156
        • International Research Associates, LLC
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Palm Harbor, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Tampa, Florida, United States, 33606
        • Meridien Research
      • Tampa, Florida, United States, 34203
        • Meridien Research
      • Winter Haven, Florida, United States, 33880
        • Clinical Research of Central Florida
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Executive Health and Research Associates, Inc.
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
      • Chicago, Illinois, United States, 60611
        • ICCT Reseach International
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • American Health Network
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • New Orleans Center for Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21234
        • Stephen R. Smith, MD
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Olive Branch Family Medical Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Diabetes and Endocrinology Specialists, Inc.
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Lipid and Diabetes Reseach Center
    • Montana
      • Bozeman, Montana, United States, 59715
        • Bozeman Deaconess Internal Medicine Associates
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
    • New York
      • Buffalo, New York, United States, 14209
        • Kaleida Health Diabetes Center
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • UNC Diabetes Care Center/Highgate Specialty Center
      • Hickory, North Carolina, United States, 28602
        • Fairbrook Medical Clinic
      • Morehead City, North Carolina, United States, 28557
        • Diabetes & Endrocrinology Consultants
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • IVA Research
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Clinical Trial Center
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc
      • Columbus, Ohio, United States, 43235
        • Opitmed Research, LTD
      • Cuyahoga Falls, Ohio, United States, 44223
        • ResEvo LLC
      • Delaware, Ohio, United States, 43015
        • Delaware Smith Clinic
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Kettering, Ohio, United States, 45429
        • Wells Institute for Health Awareness
      • Marion, Ohio, United States, 43302
        • Frederick C Smith Clinic
      • Mentor, Ohio, United States, 44060
        • Your Diabetes Endocrine Nutrition Group, LLC
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Tri-State Medical Group, Inc.
      • Jersey Shore, Pennsylvania, United States, 17740
        • Lycoming Internal Medicine, Inc.
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • New England Center for Clinical Research
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Hartwell Research Group
      • Charleston, South Carolina, United States, 29407
        • Medical Research South
      • Simpsonville, South Carolina, United States, 29681
        • Palmetto Clinical Trial Services, LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Institute Of Dallas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes and Endocrine Research Center
      • Dallas, Texas, United States, 75246
        • Baylor University Endocrine Center
      • Midland, Texas, United States, 79705
        • Diabetes Center of the Southwest
      • San Antonio, Texas, United States, 78229
        • DGD Research
      • San Antonio, Texas, United States, 78209
        • Quality Research, Inc.
    • Virginia
      • Salem, Virginia, United States, 24153
        • Salem VA Medical Center R&D Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
  • Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
  • HbA1c must be ≥7.5% and ≤10% at screening
  • Fasting Plasma Glucose must be <240 mg/dL at screening

Exclusion Criteria:

  • History of type 1 diabetes
  • History of diabetic ketoacidosis
  • NYHA Class III or IV cardiac status or hospitalization for congestive heart failure within 6 weeks prior to Visit 1
  • Treatment with any non-peroxisome proliferator-activated receptor (non-PPAR) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
  • Treatment with rosiglitazone, pioglitazone, or any PPAR investigational antidiabetic agent within 6 month prior to screening
  • Body mass index >45 kg/m2
  • Fasting triglycerides >500 mg/dL
  • Uncontrolled hypertension (sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg
  • Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: INT131 besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.
Drug: INT131 besylate
Once-daily, oral
EXPERIMENTAL: INT131 besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl
Drug: INT131 besylate
Once-daily, oral
EXPERIMENTAL: INT131 besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl
Drug: INT131 besylate
Once-daily, oral
EXPERIMENTAL: INT131 besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl
Drug: INT131 besylate
Once-daily, oral
ACTIVE_COMPARATOR: pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
Drug: Pioglitazone HCl
Once-daily, oral
Other Names:
  • Actos
PLACEBO_COMPARATOR: placebo
placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl
Drug: Placebo
Once-daily, oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
Time Frame: Weeks 0-24
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent
Weeks 0-24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
Time Frame: Weeks 0-24
The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.
Weeks 0-24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InteKrin Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INT131-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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