Clinical trial NCT06912035: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Uncontrolled Diabetes
Diabetes Mellitus Type 2
Keywords: Diacerein
Diabetes Mellitus Type 2
Uncontrolled Diabetes
Interleukin-1β
hs-CRP
TNF-α
Lead sponsor: Universitas Sriwijaya
Sponsor class: OTHER
Collaborators: name: Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia
First posted: 2025-04-04
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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?

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\]

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria

1. Pregnant or breastfeeding.
2. History of allergy to medications containing rhein.
3. Severe liver disorders.
4. Chronic kidney disease.
5. Malignancy.
6. Currently receiving hormone replacement therapy.
7. Autoimmune diseases.
8. Severe bacterial infection.
9. Osteoarthritis.
10. Use of other anti-inflammatory drugs within the past 2 weeks.

Drop-out Criteria

1. Patients who discontinue medication for more than 2 weeks.
2. Death.
3. Occurrence of serious adverse drug reactions requiring discontinuation of the medication.
4. Loss to follow-up.

Primary outcomes:
measure: Primary Outcome
timeFrame: [Time frame: From enrollment to the end of the treatment at 12 weeks]
Secondary outcomes:
measure: Secondary Outcome
timeFrame: [Time frame: From enrollment to the end of the treatment at 12 weeks]
measure: Secondary Outcome
timeFrame: [Time frame: From enrollment to the end of the treatment at 12 weeks]
measure: Secondary Outcome
timeFrame: [Time frame: From enrollment to the end of the treatment at 12 weeks]
measure: Secondary Outcome
timeFrame: [Time frame: From enrollment to the end of the treatment at 12 weeks]
Other outcomes:
Locations:
city: Palembang
country: Indonesia
facility: Universitas Sriwijaya
state: South Sumatera
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.