Type 2 Diabetes MellitusPhase 2NCT00631007

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

A Phase 2 study testing INT131 besylate and Pioglitazone HCl in people with Type 2 Diabetes Mellitus, run by InteKrin Therapeutics, Inc. at 66 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: INT131 besylate and Pioglitazone HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 367 participants
Where: 66 sitesin 2 countries
Study dates: Feb 2008to Sep 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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)

Trial locations and contacts

66 sites in 2 countries.

Country

City, postcode or hospital

66 sites in 2 countries

United States59 sites

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

Other trials in United States

Mexico7 sites

Unidad Metabolica y Cardiovascular SC
Cuernavaca, Morelos
Nucleo Medico Vallarta
Guadalajara, Jalisco
Comite Mexicano para la Prevencion de la Osteoporosis A.C.
Mexico City, Mexico DF, 06100
Centro Especializado en Diabetes y Obisidad (EDOPEC)
Mexico City, Mexico DF, 11650
Instituto Nacional de Nutricion Salvador Zubiran (INNSZ)
Mexico City, Mexico DF, 14000
Instituto Mexicano de Investigacion Clinica
Mexico City, Mexico DF
Hospital Santa Engracia
Monterrey, Nuevo León, 66220

Other trials in Mexico

About this study

Official title: 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

Conditions: Type 2 Diabetes Mellitus
Being tested: INT131 besylate, Pioglitazone HCl, Placebo
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
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Endocrine System Diseases, Nutritional and Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INT131 besylateDrug
Once-daily, oral
Pioglitazone HClDrug
Also called Actos
Once-daily, oral
PlaceboDrug
Once-daily, oral

Study groups in NCT00631007
Study group	Role	What they receive
INT131 besylate 0.5 mg	Experimental	INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl. Receives: Drug: INT131 besylate
INT131 besylate 1 mg	Experimental	INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl Receives: Drug: INT131 besylate
INT131 besylate 2 mg	Experimental	INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl Receives: Drug: INT131 besylate
INT131 besylate 3 mg	Experimental	INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl Receives: Drug: INT131 besylate
pioglitazone HCl 45 mg	Active comparator	pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate Receives: Drug: Pioglitazone HCl
placebo	Placebo comparator	placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl Receives: Drug: Placebo

What is being measured

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

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
Measured: 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.
Measured: Weeks 0-24

Timeline

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

Feb 2008Sep 2009

First posted7 Mar 2008 (estimated)
Study startFeb 2008
Primary completionAug 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 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: 367 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00631007
Sponsor's protocol ID: INT131-007
Status last verified: Aug 2010
First submitted: 27 Feb 2008
Last updated: 13 Sep 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00631007
Acronym / sponsor ID: INT131-007
Conditions: 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
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 367 participants (actual)
Lead sponsor: InteKrin Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Aug 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 7 Mar 2008 (estimated)
Results: Posted 13 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
INT131 besylate 0.5 mg	Experimental	Drug: INT131 besylateINT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.
INT131 besylate 1 mg	Experimental	Drug: INT131 besylateINT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl
INT131 besylate 2 mg	Experimental	Drug: INT131 besylateINT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl
INT131 besylate 3 mg	Experimental	Drug: INT131 besylateINT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl
pioglitazone HCl 45 mg	Active comparator	Drug: Pioglitazone HClpioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
placebo	Placebo comparator	Drug: Placeboplacebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (9 listed)

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

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
INT131 besylateOnce-daily, oral	Drug	INT131 besylate 0.5 mg, INT131 besylate 1 mg, INT131 besylate 2 mg, INT131 besylate 3 mg
Pioglitazone HClAlso: ActosOnce-daily, oral	Drug	pioglitazone HCl 45 mg
PlaceboOnce-daily, oral	Drug	placebo

Primary outcome

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

1 secondary outcome

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
Time frame: Weeks 0-24

Results and safety

Results posted to the registry on 13 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INT131 Besylate 0.5 mg	60	49
INT131 Besylate 1 mg	61	50
INT131 Besylate 2 mg	63	53
INT131 Besylate 3 mg	62	53
Pioglitazone HCl 45 mg	60	48
Placebo	61	46

Primary outcome: Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward

Time frame: Weeks 0-24. Mean (Standard Deviation). Unit: Percernt

Measure	INT131 Besylate 0.5 mg n = 60	INT131 Besylate 1 mg n = 59	INT131 Besylate 2 mg n = 61	INT131 Besylate 3 mg n = 60	Pioglitazone HCl 45 mg n = 58	Placebo n = 58
Value	-0.3 (0.86)	-0.6 (0.72)	-0.9 (0.97)	-1.0 (0.80)	-0.9 (0.94)	-0.1 (0.87)

Population analysed: Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from randomization to week 26.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INT131 Besylate 0.5 mg	1 of 60 (1.7%)	15 of 60 (25%)	Not reported
INT131 Besylate 1 mg	1 of 61 (1.6%)	37 of 61 (60.7%)	Not reported
INT131 Besylate 2 mg	2 of 63 (3.2%)	37 of 63 (58.7%)	Not reported
INT131 Besylate 3 mg	0 of 61 (0%)	35 of 61 (57.4%)	Not reported
Pioglitazone HCl 45 mg	4 of 60 (6.7%)	34 of 60 (56.7%)	Not reported
Placebo	4 of 61 (6.6%)	24 of 61 (39.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24722496DePaoli 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.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

David Orloff, MD study director

Medpace, Inc.

66 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing INT131 besylate and Pioglitazone HCl in people with Type 2 Diabetes Mellitus, run by InteKrin Therapeutics, Inc. at 66 sites in 2 countries.

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 9 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 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Mexico. 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?

Yes. Results are posted in the registry (first posted 13 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward (time frame: Weeks 0-24). 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 NCT00631007, which also lists 1 linked publication.

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 13 Sep 2010.