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CompletedNCT00631007Updated Sep 13, 2010Results posted

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

A Phase 2 interventional study of INT131 besylate and Pioglitazone HCl in Type 2 Diabetes Mellitus, sponsored by InteKrin Therapeutics, Inc.. Completed at 66 sites in 2 countries. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-09-13.

Sponsored by InteKrin Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
367
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 diabetes
  • diabetes
  • diabetes mellitus
  • diabetes mellitus, type 2
  • non-TZD
  • thiazolidinedione
  • selective peroxisome proliferator-activated receptor gamma modulator
  • SPPARM
  • peroxisome proliferator-activated receptor gamma
  • PPAR gamma
  • insulin sensitizer
  • glucose control
  • endocrinopathy
  • hypoglycemic agent
  • sulfonylurea
  • metformin
  • pioglitazone
  • nutritional and metabolic diseases
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 367 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

InteKrin Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
367 participants (actual)

Study arms

  • Experimental
    INT131 besylate 0.5 mg

    INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.

    Drug: INT131 besylate

  • Experimental
    INT131 besylate 1 mg

    INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl

    Drug: INT131 besylate

  • Experimental
    INT131 besylate 2 mg

    INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl

    Drug: INT131 besylate

  • Experimental
    INT131 besylate 3 mg

    INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl

    Drug: INT131 besylate

  • Active comparator
    pioglitazone HCl 45 mg

    pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate

    Drug: Pioglitazone HCl

  • Placebo comparator
    placebo

    placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl

    Drug: Placebo

Interventions

  • DrugINT131 besylate

    Once-daily, oral

  • DrugPioglitazone HCl

    Once-daily, oral

    Also known as: Actos

  • DrugPlacebo

    Once-daily, oral

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward

    HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent

    Time frame: Weeks 0-24

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.

    The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.

    Time frame: Weeks 0-24

07

Results

Posted Sep 13, 2010

Participant flow

Participant flow — Overall Study
MilestoneINT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlacebo
Started606163626061
Completed495053534846
Not completed11111091215
Withdrew: Adverse event020232
Withdrew: Lost to follow-up212453
Withdrew: Physician decision101002
Withdrew: Persistent hyperglycemia225125
Withdrew: Withdrawal by subject452213
Withdrew: Other210010

Outcome measures

PrimaryChange From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward

HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent

Time frame:
Weeks 0-24
Reported as:
Mean · Percernt
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
PercerntINT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlacebo
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward-0.3 ± 0.86-0.6 ± 0.72-0.9 ± 0.97-1.0 ± 0.80-0.9 ± 0.94-0.1 ± 0.87
SecondaryChange From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.

The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.

Time frame:
Weeks 0-24
Reported as:
Mean · mg/dL
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
mg/dLINT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlacebo
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.-0.3 ± 58.73-14.6 ± 48.53-28.9 ± 44.20-26.9 ± 37.23-33.2 ± 37.174.6 ± 41.71

Adverse events

Collected over Adverse events were collected from randomization to week 26.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
INT131 Besylate 0.5 mg—1/60 (1.7%)15/60 (25%)
INT131 Besylate 1 mg—1/61 (1.6%)37/61 (60.7%)
INT131 Besylate 2 mg—2/63 (3.2%)37/63 (58.7%)
INT131 Besylate 3 mg—0/61 (0%)35/61 (57.4%)
Pioglitazone HCl 45 mg—4/60 (6.7%)34/60 (56.7%)
Placebo—4/61 (6.6%)24/61 (39.3%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventINT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlacebo
Angina pectorisCardiac disorders0/600/610/630/611/600/61
Cerebrovascular accidentNervous system disorders0/600/610/630/611/600/61
Coronary artery diseaseCardiac disorders0/600/610/630/611/601/61
Non-Cardiac chest painGeneral disorders0/600/610/630/611/601/61
Pharyngeal abscessInfections and infestations0/600/610/630/611/600/61
SpermatoceleReproductive system and breast disorders1/600/610/630/610/600/61
Acute respiratory failureRespiratory, thoracic and mediastinal disorders0/600/610/630/610/601/61
AsthmaRespiratory, thoracic and mediastinal disorders0/600/610/630/610/601/61
BronchitisInfections and infestations0/601/610/630/610/600/61
Cerebral infarctionNervous system disorders0/600/610/630/610/601/61
Most frequent other events
Most frequent other events
EventINT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlacebo
Oedema peripheralGeneral disorders3/608/618/638/616/602/61
Urinary tract infectionInfections and infestations2/608/613/633/614/605/61
HypoglycemiaMetabolism and nutrition disorders0/603/617/635/617/600/61
Weight gainInvestigations0/602/611/634/616/600/61
InfluenzaInfections and infestations2/605/615/631/610/602/61
headacheNervous system disorders0/605/613/635/613/605/61
Back PainMusculoskeletal and connective tissue disorders4/602/611/630/613/600/61
Upper respiratory tract infectionInfections and infestations1/602/613/633/612/604/61
diarrhoeaGastrointestinal disorders1/602/612/633/613/604/61
ArthralgiaMusculoskeletal and connective tissue disorders2/600/614/633/610/602/61

Baseline characteristics

Age Continuous
Age Continuous(years)INT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlaceboTotal
Mean54.9 ± 8.4858.0 ± 9.1856.1 ± 7.9854.8 ± 9.7655.8 ± 10.4055.3 ± 10.9355.8 ± 9.50
Sex: Female, Male
Sex: Female, Male(Participants)INT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlaceboTotal
Female242932253228170
Male363231362833196
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)INT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlaceboTotal
Hispanic or Latino293129322831180
Not Hispanic or Latino313034293230186
Race (NIH/OMB)
Race (NIH/OMB)(Participants)INT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlaceboTotal
American Indian or Alaska Native67655736
Asian0021104
Native Hawaiian or Other Pacific Islander1000124
Black or African American741069642
White465045494446280
Region of Enrollment
Region of Enrollment(participants)INT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlaceboTotal
United States515052525149305
Mexico91111991261
Hemoglobin A1c
Hemoglobin A1c(Percent)INT131 Besylate 0.5 mgINT131 Besylate 1 mgINT131 Besylate 2 mgINT131 Besylate 3 mgPioglitazone HCl 45 mgPlaceboTotal
Mean8.3 ± 0.768.3 ± 0.718.5 ± 0.698.3 ± 0.658.2 ± 0.678.4 ± 0.808.3 ± 0.72
08

Study locations

66 sites
  • Northern California Research
    Carmichael, California 95608, United States
  • National Research Institute
    Los Angeles, California 90057, United States
  • VA San Diego Healthcare System
    San Diego, California 92161, United States
  • Apex Research Institute
    Santa Ana, California 92705, United States
  • Internal Medicine of the Rockies
    Colorado Springs, Colorado 80910, United States
  • Creekside Endocrine Associates, PC
    Denver, Colorado 80209, United States
  • Clinical Research Consulting, LLC
    Milford, Connecticut 06460, United States
  • MedStar Research Institute
    Washington D.C., District of Columbia 20003, United States
  • Clinical Research of South Florida
    Coral Gables, Florida 33134, United States
  • The Center for Diabetes and Endocrine Care
    Hollywood, Florida 33021, United States
  • Baptist Diabetes Associates, PA
    Miami, Florida 33156, United States
  • International Research Associates, LLC
    Miami, Florida 33156, United States
  • Elite Research Institute
    Miami, Florida 33169, United States
  • Suncoast Clinical Research, Inc.
    New Port Richey, Florida 34652, United States
  • Suncoast Clinical Research, Inc.
    Palm Harbor, Florida 34652, United States
  • Meridien Research
    Tampa, Florida 33606, United States
  • Meridien Research
    Tampa, Florida 34203, United States
  • Clinical Research of Central Florida
    Winter Haven, Florida 33880, United States
  • Executive Health and Research Associates, Inc.
    Atlanta, Georgia 30342, United States
  • Endocrine Research Solutions, Inc.
    Roswell, Georgia 30076, United States
  • Cedar-Crosse Research Center
    Chicago, Illinois 60607, United States
  • ICCT Reseach International
    Chicago, Illinois 60611, United States
  • American Health Network
    Indianapolis, Indiana 46254, United States
  • L-Marc Research Center
    Louisville, Kentucky 40213, United States
  • New Orleans Center for Clinical Research
    New Orleans, Louisiana 70119, United States
  • Stephen R. Smith, MD
    Baltimore, Maryland 21234, United States
  • Olive Branch Family Medical Center
    Olive Branch, Mississippi 38654, United States
  • Diabetes and Endocrinology Specialists, Inc.
    Chesterfield, Missouri 63017, United States
  • Saint Luke's Lipid and Diabetes Reseach Center
    Kansas City, Missouri 64111, United States
  • Bozeman Deaconess Internal Medicine Associates
    Bozeman, Montana 59715, United States
  • Comprehensive Clinical Research
    Berlin, New Jersey 08009, United States
  • Kaleida Health Diabetes Center
    Buffalo, New York 14209, United States
  • UNC Diabetes Care Center/Highgate Specialty Center
    Durham, North Carolina 27713, United States
  • Fairbrook Medical Clinic
    Hickory, North Carolina 28602, United States
  • Diabetes & Endrocrinology Consultants
    Morehead City, North Carolina 28557, United States
  • The Lindner Clinical Trial Center
    Cincinnati, Ohio 45219, United States
  • IVA Research
    Cincinnati, Ohio 45245, United States
  • Rapid Medical Research, Inc
    Cleveland, Ohio 44122, United States
  • Opitmed Research, LTD
    Columbus, Ohio 43235, United States
  • ResEvo LLC
    Cuyahoga Falls, Ohio 44223, United States
  • Delaware Smith Clinic
    Delaware, Ohio 43015, United States
  • Prestige Clinical Research
    Franklin, Ohio 45005, United States
  • Wells Institute for Health Awareness
    Kettering, Ohio 45429, United States
  • Frederick C Smith Clinic
    Marion, Ohio 43302, United States
  • Your Diabetes Endocrine Nutrition Group, LLC
    Mentor, Ohio 44060, United States
  • Clinical Research Source, Inc
    Perrysburg, Ohio 43551, United States
  • Tri-State Medical Group, Inc.
    Beaver, Pennsylvania 15009, United States
  • Lycoming Internal Medicine, Inc.
    Jersey Shore, Pennsylvania 17740, United States
  • New England Center for Clinical Research
    Cranston, Rhode Island 02920, United States
  • Hartwell Research Group
    Anderson, South Carolina 29621, United States
  • Medical Research South
    Charleston, South Carolina 29407, United States
  • Palmetto Clinical Trial Services, LLC
    Simpsonville, South Carolina 29681, United States
  • Dallas Diabetes and Endocrine Research Center
    Dallas, Texas 75230, United States
  • Research Institute of Dallas
    Dallas, Texas 75231, United States
  • Baylor University Endocrine Center
    Dallas, Texas 75246, United States
  • Diabetes Center of the Southwest
    Midland, Texas 79705, United States
  • Quality Research, Inc.
    San Antonio, Texas 78209, United States
  • DGD Research
    San Antonio, Texas 78229, United States
  • Salem VA Medical Center R&D Office
    Salem, Virginia 24153, United States
  • Nucleo Medico Vallarta
    Guadalajara, Jalisco, Mexico
  • Comite Mexicano para la Prevencion de la Osteoporosis A.C.
    Mexico City, Mexico DF 06100, Mexico
  • Centro Especializado en Diabetes y Obisidad (EDOPEC)
    Mexico City, Mexico DF 11650, Mexico
  • Instituto Nacional de Nutricion Salvador Zubiran (INNSZ)
    Mexico City, Mexico DF 14000, Mexico
  • Instituto Mexicano de Investigacion Clinica
    Mexico City, Mexico DF, Mexico
  • Unidad Metabolica y Cardiovascular SC
    Cuernavaca, Morelos, Mexico
  • Hospital Santa Engracia
    Monterrey, Nuevo León 66220, Mexico
09

References and documents

Publications

  • DePaoli AM, Higgins LS, Henry RR, Mantzoros C, Dunn FL; INT131-007 Study Group. Can a selective PPARgamma modulator improve glycemic control in patients with type 2 diabetes with fewer side effects compared with pioglitazone? Diabetes Care. 2014 Jul;37(7):1918-23. doi: 10.2337/dc13-2480. Epub 2014 Apr 10. PubMed 24722496 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00631007
Lead sponsor
InteKrin Therapeutics, Inc.
First posted
Mar 7, 2008
Start date
Feb 2008
Primary completion
Aug 2009
Completion
Sep 2009
Results posted
Sep 13, 2010
Last update
Sep 13, 2010

Study contacts

David Orloff, MD
study director · Medpace, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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