Diabetes Mellitus, Type IIPhase 2NCT00952445
A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus
A Phase 2 study testing T0903131 Besylate in people with Diabetes Mellitus, Type II, run by InteKrin Therapeutics, Inc. at 21 sites in United States.
Trial summary
The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- T0903131 Besylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 21 sitesUnited States
- Study dates
- Dec 2003to Jun 2004
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment
- Fasting Plasma Glucose between 126 and 240 mg/dL
- Hemoglobin-A1c (HbA1c) between 6.8% and 10.0%
- Fasting C-peptide > 0.8 ng/mL
Who cannot join
- Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening
- Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone
- BMI > 42 kg/m2
- Presence of any diabetic complications requiring chronic therapy
- Presence or history of any form of hepatic disease
- Serum creatinine > 1.8 mg/dL
- History of cardiac arrhythmias or abnormal cardiac electrophysiology
- Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Radiant Research
Anderson, South Carolina
Joslin Diabetes Center
Boston, Massachusetts
Kaleida Health Diabetes Center
Buffalo, New York
Baylor University Endocrine Center
Dallas, Texas
Dallas Diabetes and Endocrine Research Center
Dallas, Texas
Endocrine Associates of Dallas
Dallas, Texas
Duke University Medical Center
Durham, North Carolina
Radiant Research
Edina, Minnesota
GFI Research Center
Evansville, Indiana
Whittier Diabetes Institute
La Jolla, California
Charles R. Drew University
Los Angeles, California
National Research Institute
Los Angeles, California
University of Miami
Miami, Florida
Endocrine Research Specialists
Ogden, Utah
Radiant Research
Portland, Oregon
Rochester Clinical Research
Rochester, New York
Salem VA Medical Center
Salem, Virginia
Diabetes and Grandular Disease Clinic and Reseach Center
San Antonio, Texas
Lovelace Research Institute
Santa Ana, California
Radiant Research
St Louis, Missouri
St Louis Center for Clinical Research
St Louis, Missouri
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus
The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- T0903131 Besylate, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T0903131 BesylateDrug
Also called INT131 Besylate
Once daily, oral
PlaceboDrug
Once daily, oral
| Study group | Role | What they receive |
|---|---|---|
| T0903131 Besylate | Experimental | 1.0 mg Receives: Drug: T0903131 Besylate |
| T0903131 Besylate (higher dose) | Experimental | 10.0 mg Receives: Drug: T0903131 Besylate |
| Placebo | Placebo comparator | Once daily, oral Receives: Drug: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startDec 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IIStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- InteKrin Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952445
- Sponsor's protocol ID
- T-131-004
- Status last verified
- Oct 2022
- First submitted
- 4 Aug 2009
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Dunn FL, Higgins LS, Fredrickson J, DePaoli AM; INT131-004 study group. Selective modulation of PPARgamma activity can lower plasma glucose without typical thiazolidinedione side-effects in patients with Type 2 diabetes. J Diabetes Complications. 2011 May-Jun;25(3):151-8. doi: 10.1016/j.jdiacomp.2010.06.006. Epub 2010 Aug 23.
PubMed 20739195
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00952445
- Acronym / sponsor ID
- T-131-004
- Conditions
- Diabetes Mellitus, Type II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- InteKrin Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Jun 2004 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T0903131 Besylate | Experimental | Drug: T0903131 Besylate1.0 mg |
| T0903131 Besylate (higher dose) | Experimental | Drug: T0903131 Besylate10.0 mg |
| Placebo | Placebo comparator | Drug: PlaceboOnce daily, oral |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment
- Fasting Plasma Glucose between 126 and 240 mg/dL
- Hemoglobin-A1c (HbA1c) between 6.8% and 10.0%
- Fasting C-peptide > 0.8 ng/mL
Key exclusion criteria (8 listed)
- Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening
- Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone
- BMI > 42 kg/m2
- Presence of any diabetic complications requiring chronic therapy
- Presence or history of any form of hepatic disease
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 |
|---|---|---|
| T0903131 BesylateAlso: INT131 BesylateOnce daily, oral | Drug | T0903131 Besylate, T0903131 Besylate (higher dose) |
| PlaceboOnce daily, oral | Drug | Placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 20739195Dunn FL, Higgins LS, Fredrickson J, DePaoli AM; INT131-004 study group. Selective modulation of PPARgamma activity can lower plasma glucose without typical thiazolidinedione side-effects in patients with Type 2 diabetes. J Diabetes Complications. 2011 May-Jun;25(3):151-8. doi: 10.1016/j.jdiacomp.2010.06.006. Epub 2010 Aug 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T0903131 Besylate in people with Diabetes Mellitus, Type II, run by InteKrin Therapeutics, Inc. at 21 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 8 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 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00952445, 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 19 Oct 2022.