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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

367

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

February 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (ESTIMATE)

March 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2010

Last Update Submitted That Met QC Criteria

August 18, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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