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Type 2 DiabetesINSPIREDNCT02639988

Impact of Rheumatoid Arthritis on the Course of Type 2 Diabetes During a Longitudinal Follow-up of 5 Years

An observational study of Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether patients with rheumatoid arthritis and type 2 diabetes experience a more severe disease course compared to control patients with osteoarthritis and type 2 diabetes Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
How many people
176 participants
Where
1 siteFrance
Study dates
13 Apr 2016to 30 May 2022
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients recruited in five rheumatology departments

Who may be able to join

  • Patients
  • Adults (>18 years)
  • Rheumatoid arthritis fulfilling American College of Rheumatology (ACR )1987 or European League Against Rheumatism (ACR/EULAR) 2010 classification criteria
  • Type 2 diabetes (HbA1c ≥6.5% OR fasting glycemia≥7 mmol/l OR glycemia 120 min after 75 mg glucose ingestion ≥ 11.1 mmol/l OR symptoms of hyperglycemia with glycemia ≥11.1 mmol/l)
  • Affiliated to social security system
  • Controls
Show all 10Show fewer
  • Adults (>18 years) matched for age, sex and BMI with patients with rheumatoid arthritis
  • Osteoarthritis (knee, hip, spine and hand)
  • Type 2 diabetes with disease duration matched with patients with rheumatoid arthritis
  • Affiliated to social security system

Who cannot join

  • Patient not able to understand study implication and rules
  • Patient opposed to participate to the study
  • Transient diabetes
  • Gestational diabetes
  • Secondary diabetes

Trial locations and contacts

1 site in 1 country.

France1 site

  • AP-HP, Cochin hospital

    Paris, Paris, 75014

Other trials in France

About this study

Official title: Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus

The purpose of this study is to determine whether patients with rheumatoid arthritis and type 2 diabetes experience a more severe disease course compared to control patients with osteoarthritis and type 2 diabetes

Conditions
Type 2 Diabetes
Keywords
type 2 diabetes mellitus, Rheumatoid arthritis
Medical subject headings
Diabetes Mellitus, Type 2, Arthritis, Rheumatoid

What participants receive

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

Study groups in NCT02639988
Study groupRoleWhat they receive
rheumatoid arthritis and type 2 diabetesNot described
osteoarthritis and type 2 diabetesNot described

What is being measured

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

  1. Time to the addition of a new treatment for type 2 diabetes in months

    addition of a new treatment includes insulin requirement

    Measured: five years

Secondary outcomes (7)

  1. Glycated haemoglobin (HbA1c) levels in %

    Measured: two years

  2. Insulin resistance (HOMA-IR), absolute value

    Measured: two years

  3. Proportion of patients requesting insulin in %

    Measured: two years

  4. Proportion of patients with type 2 diabetes-related acute complications in %

    Measured: two years

  5. Proportion of patients requiring the addition of a new treatment for type 2 diabetes in %

    Measured: five years

  6. Proportion of patients with increased glycated haemoglobin (HbA1c) levels between 2 visits in %

    Measured: five years

  7. Proportion of patients with increased HOMA-IR between 2 visits in %

    Measured: five years

Timeline

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

  1. First posted28 Dec 2015 (estimated)
  2. Study start13 Apr 2016
  3. Primary completion30 May 2022
  4. Study completion30 May 2022

Why it stopped: Given the number of patients included in the cross-sectional analysis and the lack of financial resources, it was decided to focus on cross-sectional data.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02639988
Sponsor's protocol ID
NI15005
Acronym
INSPIRED
Status last verified
Sep 2025
First submitted
30 Nov 2015
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No

Publications

  • Meune C, Touze E, Trinquart L, Allanore Y. High risk of clinical cardiovascular events in rheumatoid arthritis: Levels of associations of myocardial infarction and stroke through a systematic review and meta-analysis. Arch Cardiovasc Dis. 2010 Apr;103(4):253-61. doi: 10.1016/j.acvd.2010.03.007. Epub 2010 May 18.

    PubMed 20656636

  • Meune C, Touze E, Trinquart L, Allanore Y. Trends in cardiovascular mortality in patients with rheumatoid arthritis over 50 years: a systematic review and meta-analysis of cohort studies. Rheumatology (Oxford). 2009 Oct;48(10):1309-13. doi: 10.1093/rheumatology/kep252. Epub 2009 Aug 20.

    PubMed 19696061

  • Liao KP, Solomon DH. Traditional cardiovascular risk factors, inflammation and cardiovascular risk in rheumatoid arthritis. Rheumatology (Oxford). 2013 Jan;52(1):45-52. doi: 10.1093/rheumatology/kes243. Epub 2012 Sep 16.

    PubMed 22986289

  • Reilly MP, Wolfe ML, Rhodes T, Girman C, Mehta N, Rader DJ. Measures of insulin resistance add incremental value to the clinical diagnosis of metabolic syndrome in association with coronary atherosclerosis. Circulation. 2004 Aug 17;110(7):803-9. doi: 10.1161/01.CIR.0000138740.84883.9C. Epub 2004 Aug 2.

    PubMed 15289378

  • Chung CP, Oeser A, Solus JF, Gebretsadik T, Shintani A, Avalos I, Sokka T, Raggi P, Pincus T, Stein CM. Inflammation-associated insulin resistance: differential effects in rheumatoid arthritis and systemic lupus erythematosus define potential mechanisms. Arthritis Rheum. 2008 Jul;58(7):2105-12. doi: 10.1002/art.23600.

    PubMed 18576352

  • Dessein PH, Joffe BI. Insulin resistance and impaired beta cell function in rheumatoid arthritis. Arthritis Rheum. 2006 Sep;54(9):2765-75. doi: 10.1002/art.22053.

    PubMed 16947779

  • Ashida R, Ihn H, Mimura Y, Jinnin M, Asano Y, Kubo M, Tamaki K. Clinical features of scleroderma patients with contracture of phalanges. Clin Rheumatol. 2007 Aug;26(8):1275-7. doi: 10.1007/s10067-006-0490-0. Epub 2006 Dec 15.

    PubMed 17171315

  • Kiortsis DN, Mavridis AK, Vasakos S, Nikas SN, Drosos AA. Effects of infliximab treatment on insulin resistance in patients with rheumatoid arthritis and ankylosing spondylitis. Ann Rheum Dis. 2005 May;64(5):765-6. doi: 10.1136/ard.2004.026534. Epub 2004 Sep 30.

    PubMed 15458960

  • Rosenvinge A, Krogh-Madsen R, Baslund B, Pedersen BK. Insulin resistance in patients with rheumatoid arthritis: effect of anti-TNFalpha therapy. Scand J Rheumatol. 2007 Mar-Apr;36(2):91-6. doi: 10.1080/03009740601179605.

    PubMed 17476613

  • Solomon DH, Massarotti E, Garg R, Liu J, Canning C, Schneeweiss S. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011 Jun 22;305(24):2525-31. doi: 10.1001/jama.2011.878.

    PubMed 21693740

  • Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. doi: 10.1056/NEJMoa066224. Epub 2006 Dec 4.

    PubMed 17145742

  • Arrieta F, Pinera M, Iglesias P, Nogales P, Salinero-Fort MA, Abanades JC, Botella-Carretero JI, Calanas A, Balsa JA, Zamarron I, Rovira A, Vazquez C; ESD2 Group. Metabolic control and chronic complications during a 3-year follow-up period in a cohort of type 2 diabetic patients attended in primary care in the Community of Madrid (Spain). Endocrinol Nutr. 2014 Jan;61(1):11-7. doi: 10.1016/j.endonu.2013.09.002. Epub 2013 Oct 30.

    PubMed 24182687

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Given the number of patients included in the cross-sectional analysis and the lack of financial resources, it was decided to focus on cross-sectional data.). Results are not available in the source record.

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?

Time to the addition of a new treatment for type 2 diabetes in months (time frame: five years). 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 NCT02639988, which also lists 12 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 15 Sep 2025.

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