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Completed

NCT Number: 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

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]

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Key information

Conditions

Uncontrolled Diabetes Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Universitas Sriwijaya

Palembang, South Sumatera, 30126, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Pregnant or breastfeeding.
  • History of allergy to medications containing rhein.
  • Severe liver disorders.
  • Chronic kidney disease.
  • Malignancy.
  • Currently receiving hormone replacement therapy.
  • 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.

Treatment and study plan

Diacerein 50 mg Capsule

Drug

The patients received diacerein capsules

Placebo

Drug

Patients received placebo capsules

Primary outcomes

  1. Primary Outcome

    Time frame: [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 outcomes

  1. Secondary Outcome

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

    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.

  2. Secondary Outcome

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

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

  3. Secondary Outcome

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

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

  4. Secondary Outcome

    Time frame: [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.

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Collaborators

  • Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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