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

Phase 2

Completed

• Conditions: Uncontrolled Diabetes; Diabetes Mellitus Type 2
• Interventions: Drug: Diacerein 50 mg Capsule; Drug: Placebo

• Registration Number: NCT06912035
• Lead Sponsor: Universitas Sriwijaya

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.

Study Timeline

• Study Start: 2024-06-21
• Primary Completion: 2024-11-08
• Study Completion: 2024-11-08
• Status Verified: 2025-03
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diacerein 50 mg capsules	Diacerein 50 mg Capsule	The patients were given a capsule containing Diacerein 50 mg twice a day
Placebo	Placebo	Patients received placebo capsules

Primary Outcome Measures

Name	Time	Method
Primary Outcome	[Time frame: From enrollment to the end of the treatment at 12 weeks]	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.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	[Time frame: From enrollment to the end of the treatment at 12 weeks]	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.

Trial Locations

Locations (1)

Universitas Sriwijaya; 🇮🇩 Palembang, South Sumatera, Indonesia