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

Universitas Sriwijaya

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetes Mellitus Type 2; Uncontrolled Diabetes

Treatments: Drug: Placebo; Drug: Diacerein 50 mg Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06912035

DP0403/DXVIII0608/ETIK007/2025

Details and patient eligibility

About

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]

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 60 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Diacerein 50 mg capsules

Experimental group

Description:

The patients were given a capsule containing Diacerein 50 mg twice a day

Treatment:

Drug: Diacerein 50 mg Capsule

Placebo

Placebo Comparator group

Description:

Patients received placebo capsules

Treatment:

Drug: Placebo