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Uncontrolled DiabetesPhase 2/3NCT06912035

Efficacy of Diacerein Supplementation on Interleukin-1β, Hs-CRP, TNF-α Levels and Glycemic Control in Uncontrolled Type 2 Diabetes Mellitus Patients at Dr. Mohammad Hoesin General Hospital Palembang

A Phase 2/3 study testing Diacerein 50 mg Capsule in people with Uncontrolled Diabetes and Diabetes Mellitus Type 2, run by Universitas Sriwijaya at 1 site in Indonesia.

Completed

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

Official record
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Trial summary

The goal of this clinical trial is to learn if diacerein supplementation can help improve inflammation and glycemic control in adults with uncontrolled type 2 diabetes. It will also study the safety and tolerability of diacerein. Read more about this study

Who is it for?
Ages 60 to 60 years
What is being tested?
Diacerein 50 mg Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteIndonesia
Study dates
21 Jun 2024to 8 Nov 2024
Phase
Phase 2/3
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 60 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients diagnosed with uncontrolled type 2 diabetes mellitus who are receiving treatment at Dr. Mohammad Hoesin General Hospital, Palembang.
  • Male and female patients aged 40-59 years.
  • Willing to participate in the study by signing the informed consent form.

Who cannot join

  • Pregnant or breastfeeding.
  • History of allergy to medications containing rhein.
  • Severe liver disorders.
  • Chronic kidney disease.
  • Malignancy.
  • Currently receiving hormone replacement therapy.
Show all 15Show fewer
  • Autoimmune diseases.
  • Severe bacterial infection.
  • Osteoarthritis.
  • Use of other anti-inflammatory drugs within the past 2 weeks.
  • Drop-out Criteria
  • Patients who discontinue medication for more than 2 weeks.
  • Death.
  • Occurrence of serious adverse drug reactions requiring discontinuation of the medication.
  • Loss to follow-up.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Universitas Sriwijaya

    Palembang, South Sumatera, 30126

Other trials in Indonesia

About this study

Official title: EFFICACY OF DIACEREIN ADDITION ON INTERLEUKIN-1Β, HS-CRP, TNF-Α LEVELS AND GLYCEMIC CONTROL IN UNCONTROLLED TYPE 2 DIABETES MELLITUS PATIENTS AT DR. MOHAMMAD HOESIN GENERAL HOSPITAL PALEMBANG

The goal of this clinical trial is to learn if diacerein supplementation can help improve inflammation and glycemic control in adults with uncontrolled type 2 diabetes. It will also study the safety and tolerability of diacerein. The main questions it aims to answer are:

  • Does diacerein lower levels of inflammatory markers like interleukin-1β, hs-CRP, and TNF-α?
  • Does diacerein improve blood sugar control?
  • What side effects or problems do participants have when taking diacerein?
Read more

Researchers will compare diacerein to a placebo (a look-alike substance with no active drug) to see if it works better for managing type 2 diabetes.

Participants will:

  • Be adults aged 40-60 with uncontrolled type 2 diabetes
  • Take either diacerein or a placebo every day for 12 weeks
  • Visit the clinic for blood tests and monitoring at the beginning and end of the trial
  • Be evaluated for side effects and medication adherence]
Read the detailed description

The study aimed to evaluate the efficacy of diacerein supplementation compared to placebo towards interleukin-1β, hs-CRP, TNF-α levels and glycemic control in uncontrolled type 2 diabetes mellitus patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited 40-60 years old with uncontrolled type 2 diabetes mellitus. Participants were randomized into two groups receiving diacerein add-on therapy or placebo. Evaluations were conducted for side effects and adherence. towards Interleukin-1β, hs-CRP, TNF-α levels and glycemic control were evaluated at the beginning and at the end of the 12 weeks trial for analysis.

Being tested
Diacerein 50 mg Capsule, Placebo
Keywords
Diacerein, Diabetes Mellitus Type 2, Uncontrolled Diabetes, Interleukin-1β, hs-CRP, TNF-α
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.

  • Diacerein 50 mg CapsuleDrug

    The patients received diacerein capsules

  • PlaceboDrug

    Patients received placebo capsules

Study groups in NCT06912035
Study groupRoleWhat they receive
Diacerein 50 mg capsulesExperimentalThe patients were given a capsule containing Diacerein 50 mg twice a day
Receives: Drug: Diacerein 50 mg Capsule
PlaceboPlacebo comparatorPatients received placebo capsules
Receives: Drug: Placebo

What is being measured

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

  1. Primary Outcome

    To determine the effectiveness of adding diacerein compared to placebo towards Interleukin-1β, hs-CRP, TNF-α levels and glycemic control in uncontrolled type 2 diabetes mellitus patients.

    Measured: [Time frame: From enrollment to the end of the treatment at 12 weeks]

Secondary outcomes (4)

  1. Secondary Outcome

    To analyze the difference in levels of HbA1C and fasting plasma glucose (FPG) before and after the addition of diacerein in patients with uncontrolled diabetes mellitus.

    Measured: [Time frame: From enrollment to the end of the treatment at 12 weeks]

  2. Secondary Outcome

    To analyze the difference in levels of Interleukin-1β before and after the addition of diacerein in patients with uncontrolled diabetes mellitus.

    Measured: [Time frame: From enrollment to the end of the treatment at 12 weeks]

  3. Secondary Outcome

    To analyze the difference in levels of hs-CRP before and after the addition of diacerein in patients with uncontrolled diabetes mellitus.

    Measured: [Time frame: From enrollment to the end of the treatment at 12 weeks]

  4. Secondary Outcome

    To analyze the factors associated with changes in serum interleukin-1β, hs-CRP, TNF-α and glycemic control before and after the addition of diacerein in patients with uncontrolled type 2 diabetes mellitus.

    Measured: [Time frame: From enrollment to the end of the treatment at 12 weeks]

Timeline

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

  1. First posted4 Apr 2025
  2. Study start21 Jun 2024
  3. Primary completion8 Nov 2024
  4. Study completion8 Nov 2024

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06912035
Sponsor's protocol ID
DP0403/DXVIII0608/ETIK007/2025
Status last verified
Mar 2025
First submitted
28 Mar 2025
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tres GS, Fuchs SC, Piovesan F, Koehler-Santos P, Pereira FDS, Camey S, Lisboa HK, Moreira LB. Effect of Diacerein on Metabolic Control and Inflammatory Markers in Patients with Type 2 Diabetes Using Antidiabetic Agents: A Randomized Controlled Trial. J Diabetes Res. 2018 Apr 2;2018:4246521. doi: 10.1155/2018/4246521. eCollection 2018.

    PubMed 29805981

  • Cardoso CRL, Leite NC, Carlos FO, Loureiro AA, Viegas BB, Salles GF. Efficacy and Safety of Diacerein in Patients With Inadequately Controlled Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Oct;40(10):1356-1363. doi: 10.2337/dc17-0374. Epub 2017 Aug 17.

    PubMed 28818994

  • Villar MM, Martinez-Abundis E, Preciado-Marquez RO, Gonzalez-Ortiz M. Effect of diacerein as an add-on to metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. Arch Endocrinol Metab. 2017 Mar-Apr;61(2):188-192. doi: 10.1590/2359-3997000000242. Epub 2017 Feb 13.

    PubMed 28225996

  • Jangsiripornpakorn J, Srisuk S, Chailurkit L, Nimitphong H, Saetung S, Ongphiphadhanakul B. The glucose-lowering effect of low-dose diacerein and its responsiveness metabolic markers in uncontrolled diabetes. BMC Res Notes. 2022 Mar 4;15(1):91. doi: 10.1186/s13104-022-05974-9.

    PubMed 35246243

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Diacerein 50 mg Capsule in people with Uncontrolled Diabetes and Diabetes Mellitus Type 2, run by Universitas Sriwijaya at 1 site in Indonesia.

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 3 inclusion and 15 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 4 Apr 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 Indonesia. 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?

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.

What does the primary outcome measure?

Primary Outcome (time frame: [Time frame: From enrollment to the end of the treatment at 12 weeks]). 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 NCT06912035, which also lists 4 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 4 Apr 2025.

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