Type 2 DiabetesPhase 2/3TINSAL-T2DNCT00392678

Targeting INflammation Using SALsalate in Type 2 Diabetes (TINSAL-T2D)

A Phase 2/3 study testing Salsalate in people with Type 2 Diabetes, run by Joslin Diabetes Center at 16 sites in United States.

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Salsalate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 277 participants
Where: 16 sitesUnited States
Study dates: Oct 2006to Dec 2010
Phase: Phase 2/3
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue, or alpha-glucosidase inhibitors, or a low-dose combination of these at ≤ 50% maximal dose (see Appendix). Dosing is stable for 8 weeks prior to randomization.
FPG ≤ 225 mg/dL and HbA1c>7% and ≤9.5% at screening
Age ≥18 and <75
Women of childbearing potential agree to use an appropriate contraceptive method (hormonal, IUD, or diaphragm)

Who cannot join

Type 1 diabetes and/or history of ketoacidosis determined by medical history
History of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation
History of long-term therapy with insulin (>30 days) within the last year
Therapy with rosiglitazone (Avandia) or pioglitazone (Actos), or extendin-4 (Byetta), alone or in combination in the previous 6 months
Pregnancy or lactation
Patients requiring corticosteroids within 3 months or recurrent continuous oral corticosteroid treatment (more than 2 weeks)

Show all 27Show fewer

Use of weight loss drugs [e.g., Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanol-amine), or similar over-the-counter medications] within 3 months of screening or intentional weight loss of ≥ 10 lbs in the previous 6 months
Surgery within 30 days prior to screening
Serum creatinine >1.4 for women and >1.5 for men or eGFR <60 [possible chronic kidney disease stage 3 or greater calculated using the Modification of Diet in Renal Disease (MDRD) equation.
History of chronic liver disease including hepatitis B or C
History of peptic ulcer or endoscopy demonstrated gastritis
History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
History of malignancy, except participants who have been disease-free for greater than 10 years, or whose only malignancy has been basal or squamous cell skin carcinoma
New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure
History of unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months
Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg on three or more assessments on more than one day)
History of drug or alcohol abuse, or current weekly alcohol consumption >10 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)
Hemoglobin <12 g/dL (males), <10 g/dL (females) at screening
Platelets <100,000 cu mm at screening.
AST (SGOT) >2.50 x ULN or ALT (SGPT) >2.50 x ULN at screening
Total Bilirubin >1.50 x ULN at screening
Triglycerides (TG) >500 mg/dL at screening
Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study
Previous allergy to aspirin
Chronic or continuous use (daily for more than 7 days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months
Use of warfarin (Coumadin), clopidogrel (Plavix) or other anticoagulants
Use of probenecid (Benemid, Probalan), sulfinpyrazone (Anturane) or other uricosuric agents

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Kaiser Permanente
Atlanta, Georgia, 30084
Emory School of Medicine
Atlanta, Georgia, 30303
Joslin Diabetes Center
Boston, Massachusetts, 02215
Kaleida Health Center
Buffalo, New York, 14226
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Texas Southwestern
Dallas, Texas, 75390
Chapel Medical Group
New Haven, Connecticut, 06511
North Shore Diabetes and Endocrine Associates
New Hyde Park, New York, 11042
Tulane University
New Orleans, Louisiana, 70112
Columbia University
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68105
University of Rochester Medical Center
Rochester, New York, 14642
Washington University School of Medicine
St Louis, Missouri, 63110
MedStar Research Institute
Washington D.C., District of Columbia, 20003-4393
Endocrine Clinical Research
Winter Park, Florida, 32746

Other trials in United States

About this study

Official title: Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate

Growing evidence over recent years supports a potential role for low grade chronic inflammation in the pathogenesis of insulin resistance and type 2 diabetes. In this study we will determine whether salsalate, a member of the commonly used Non-Steroidal Anti-Inflammatory Drug (NSAID) class, is effective in lowering sugars in patients with type 2 diabetes. The study will determine whether salicylates represent a new pharmacological option for diabetes management. The study is conducted in two stages. The first stage is a dose ranging study, administering salsalate compared to placebo over three months. The primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes; the tolerability of salsalate use in patients with type 2 diabetes (T2D); and the effects of salsalate on measures of inflammation, the metabolic syndrome, and cardiac risk.

The second stage is a second trial and posted under alternate registration.

Read the detailed description

The primary objective of the first stage of the TINSAL-T2D trial is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control. The trial is a multicenter, single mask lead-in, double masked placebo controlled dose ranging study, comparing salsalte to placebo over 3 months.

Conditions: Type 2 Diabetes
Being tested: Salsalate, Placebo
Keywords: Type 2 Diabetes, Inflammation, Obesity, Metabolic Syndrome
Medical subject headings: Diabetes Mellitus, Type 2, Inflammation, Obesity, Metabolic Syndrome

What participants receive

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

SalsalateDrug
Also called Disalcid, Salicylsalicylic acid
Placebo and Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided
PlaceboDrug
Also called Placebo to Salsalate
Placebo to Salsalate

Study groups in NCT00392678
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo, appearance matched to active drug Receives: Drug: Placebo
3 gram	Active comparator	Salsalate 3.0 grams daily, divided Receives: Drug: Salsalate
3.5 gram	Active comparator	Salsalate 3.5 g daily, divided Receives: Drug: Salsalate
4 gram	Active comparator	Salsalate 4.0 g daily, divided Receives: Drug: Salsalate

What is being measured

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

Change in HbA1c Baseline to End of Trial in TINSAL-T2D Stage 1
The primary outcome for the TINSAL-T2D study is change in HbA1c level from baseline to week 14 (stage 1) in the intent-to-treat (ITT) population with last observation carried forward.
Measured: 14 week

Secondary outcomes (6)

Change in HbA1c
Change from baseline to either 14 or 26 weeks, or last HbA1c measurement prior to rescue therapy
Measured: 14 week
Change From Baseline and Trends in Fasting Glucose Over Time
Measured: 14 week
Change in Lipids
Change in lipids (low-density lipoprotein cholesterol [LDL-C], non-high-density lipoprotein cholesterol [non-HDL-C], triglycerides [TG], total cholesterol [TC], high-density lipoprotein cholesterol [HDL C], TC/HDL-C ratio, and LDL-C/HDL-C ratio)
LDL-C/HDL-C ratio not calculated
Measured: 14 week
Change From Baseline in 14-week Insulin, C-peptide, Homeostasis Model [HOMA] Index
HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in insulin from Baseline to Week 14 in data table below.
Measured: Baseline, week 14
Safety and Tolerability
See adverse event module for details. Safety and tolerability of salsalate compared to placebo as assessed by adverse events.
Measured: 14 weeks
Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index
HOMA-IR was not calcuated due to potential confounding effect of salicylates to inhibit insulin clearance. Change in C-peptide from Baseline to Week 14 is in the data table below
Measured: Baseline, week 14

Timeline

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

Oct 2006Dec 2010

First posted26 Oct 2006 (estimated)
Study startOct 2006
Primary completionJul 2008
Study completionDec 2010

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 (5)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 277 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00392678
Sponsor's protocol ID: CHS 06-20, NIH U01 DK74556
Other IDs: U01DK074556
Acronym: TINSAL-T2D
Status last verified: Mar 2019
First submitted: 25 Oct 2006
Last updated: 8 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Shoelson SE, Lee J, Goldfine AB. Inflammation and insulin resistance. J Clin Invest. 2006 Jul;116(7):1793-801. doi: 10.1172/JCI29069.
PubMed 16823477
Fleischman A, Shoelson SE, Bernier R, Goldfine AB. Salsalate improves glycemia and inflammatory parameters in obese young adults. Diabetes Care. 2008 Feb;31(2):289-94. doi: 10.2337/dc07-1338. Epub 2007 Oct 24.
PubMed 17959861
Goldfine AB, Silver R, Aldhahi W, Cai D, Tatro E, Lee J, Shoelson SE. Use of salsalate to target inflammation in the treatment of insulin resistance and type 2 diabetes. Clin Transl Sci. 2008 May;1(1):36-43. doi: 10.1111/j.1752-8062.2008.00026.x.
PubMed 19337387
Goldfine AB, Fonseca V, Jablonski KA, Chen YD, Tipton L, Staten MA, Shoelson SE; Targeting Inflammation Using Salsalate in Type 2 Diabetes Study Team. Salicylate (salsalate) in patients with type 2 diabetes: a randomized trial. Ann Intern Med. 2013 Jul 2;159(1):1-12. doi: 10.7326/0003-4819-159-1-201307020-00003.
PubMed 23817699
Goldfine AB, Fonseca V, Jablonski KA, Pyle L, Staten MA, Shoelson SE; TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) Study Team. The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial. Ann Intern Med. 2010 Mar 16;152(6):346-57. doi: 10.7326/0003-4819-152-6-201003160-00004.
PubMed 20231565

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?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Targeting Inflammation in Type 2 Diabetes: Clinical Trial Using Salsalate
ClinicalTrials.gov ID: NCT00392678
Acronym / sponsor ID: TINSAL-T2D / CHS 06-20, NIH U01 DK74556
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, Inflammation, Obesity, Metabolic Syndrome
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 277 participants (actual)
Lead sponsor: Joslin Diabetes CenterUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Oct 2006
Primary completion: Jul 2008 (actual)
Study completion: Dec 2010 (actual)
First posted: 26 Oct 2006 (estimated)
Results: Posted 26 Jul 2013

Clinical summary

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

The second stage is a second trial and posted under alternate registration.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo, appearance matched to active drug
3 gram	Active comparator	Drug: SalsalateSalsalate 3.0 grams daily, divided
3.5 gram	Active comparator	Drug: SalsalateSalsalate 3.5 g daily, divided
4 gram	Active comparator	Drug: SalsalateSalsalate 4.0 g daily, divided

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Type 2 diabetes on diet and exercise therapy or monotherapy with metformin, insulin secretagogue, or alpha-glucosidase inhibitors, or a low-dose combination of these at ≤ 50% maximal dose (see Appendix). Dosing is stable for 8 weeks prior to randomization.
FPG ≤ 225 mg/dL and HbA1c>7% and ≤9.5% at screening
Age ≥18 and <75
Women of childbearing potential agree to use an appropriate contraceptive method (hormonal, IUD, or diaphragm)

Key exclusion criteria (27 listed)

Type 1 diabetes and/or history of ketoacidosis determined by medical history
History of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation
History of long-term therapy with insulin (>30 days) within the last year
Therapy with rosiglitazone (Avandia) or pioglitazone (Actos), or extendin-4 (Byetta), alone or in combination in the previous 6 months
Pregnancy or lactation

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
SalsalateAlso: Disalcid, Salicylsalicylic acidPlacebo and Salsalate 3.0 g/d; 3.5 g/d; 4.0 g/d orally, divided	Drug	3 gram, 3.5 gram, 4 gram
PlaceboAlso: Placebo to SalsalatePlacebo to Salsalate	Drug	Placebo

Primary outcome

Change in HbA1c Baseline to End of Trial in TINSAL-T2D Stage 1
Time frame: 14 week
The primary outcome for the TINSAL-T2D study is change in HbA1c level from baseline to week 14 (stage 1) in the intent-to-treat (ITT) population with last observation carried forward.

6 secondary outcomes

Change in HbA1c
Time frame: 14 week
Change From Baseline and Trends in Fasting Glucose Over Time
Time frame: 14 week
Change in Lipids
Time frame: 14 week
Change From Baseline in 14-week Insulin, C-peptide, Homeostasis Model [HOMA] Index
Time frame: Baseline, week 14
Safety and Tolerability
Time frame: 14 weeks
Change in Insulin, C-peptide, Homeostasis Model [HOMA] Index
Time frame: Baseline, week 14

Results and safety

Results posted to the registry on 26 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3 Gram	27	27
3.5 Gram	27	26
4 Gram	27	25
Placebo	27	26

Primary outcome: Change in HbA1c Baseline to End of Trial in TINSAL-T2D Stage 1

Time frame: 14 week. Mean (95% Confidence Interval). Unit: % (units of HbA1c)

Measure	3.0 g/d n = 27	3.5 g/d n = 26	4.0 g/d n = 25	Placebo n = 26
Value	-0.36 (-0.55 to -0.17)	-0.34 (-0.54 to -0.15)	-0.49 (-0.69 to -0.30)	-0.01 (-0.20 to 0.19)

3.0 g/d vs 3.5 g/d vs 4.0 g/d vs Placebo: p <0.05, Mixed Models Analysis

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening, 4 week placebo run in, 14 week treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Salsalate 3.0 g/d	1 of 27 (3.7%)	27 of 27 (100%)	0 of 27
Salsalate 3.5 g/d	2 of 27 (7.4%)	27 of 27 (100%)	0 of 27
Salsalate 4.0 g/d	0 of 27 (0%)	27 of 27 (100%)	0 of 27
Placebo	1 of 27 (3.7%)	25 of 27 (92.6%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16823477Shoelson SE, Lee J, Goldfine AB. Inflammation and insulin resistance. J Clin Invest. 2006 Jul;116(7):1793-801. doi: 10.1172/JCI29069.
Background: PubMed 17959861Fleischman A, Shoelson SE, Bernier R, Goldfine AB. Salsalate improves glycemia and inflammatory parameters in obese young adults. Diabetes Care. 2008 Feb;31(2):289-94. doi: 10.2337/dc07-1338. Epub 2007 Oct 24.
Background: PubMed 19337387Goldfine AB, Silver R, Aldhahi W, Cai D, Tatro E, Lee J, Shoelson SE. Use of salsalate to target inflammation in the treatment of insulin resistance and type 2 diabetes. Clin Transl Sci. 2008 May;1(1):36-43. doi: 10.1111/j.1752-8062.2008.00026.x.
Background: PubMed 23817699Goldfine AB, Fonseca V, Jablonski KA, Chen YD, Tipton L, Staten MA, Shoelson SE; Targeting Inflammation Using Salsalate in Type 2 Diabetes Study Team. Salicylate (salsalate) in patients with type 2 diabetes: a randomized trial. Ann Intern Med. 2013 Jul 2;159(1):1-12. doi: 10.7326/0003-4819-159-1-201307020-00003.
Results publication: PubMed 20231565Goldfine AB, Fonseca V, Jablonski KA, Pyle L, Staten MA, Shoelson SE; TINSAL-T2D (Targeting Inflammation Using Salsalate in Type 2 Diabetes) Study Team. The effects of salsalate on glycemic control in patients with type 2 diabetes: a randomized trial. Ann Intern Med. 2010 Mar 16;152(6):346-57. doi: 10.7326/0003-4819-152-6-201003160-00004.

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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.

Steven E. Sheolson, MD, PhD principal investigator

Joslin Diabetes Center

Allison B. Goldfine, MD study director

Joslin Diabetes Center

Vivian Fonseca, MD study director

Tulane University

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Salsalate in people with Type 2 Diabetes, run by Joslin Diabetes Center at 16 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 27 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 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Jul 2013). 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 in HbA1c Baseline to End of Trial in TINSAL-T2D Stage 1 (time frame: 14 week). 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 NCT00392678, which also lists 5 linked publications.

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 8 Apr 2019.