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

NCT06912035 | Completed Phase 2 DMC

• 1 other identifier: DP0403/DXVIII0608/ETIK007/2025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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\]

Conditions

Uncontrolled Diabetes; Diabetes Mellitus Type 2

Keywords

Diacerein; Diabetes Mellitus Type 2; Uncontrolled Diabetes; Interleukin-1β; hs-CRP; TNF-α

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Secondary Outcome

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

• Secondary Outcome

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

• Secondary Outcome

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

• Secondary Outcome

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

Study Arms (2)

Diacerein 50 mg capsules

EXPERIMENTAL

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

Drug: Diacerein 50 mg Capsule

Placebo

PLACEBO COMPARATOR

Patients received placebo capsules

Drug: Placebo

Interventions

Diacerein 50 mg Capsule DRUG

The patients received diacerein capsules

Diacerein 50 mg capsules

Placebo DRUG

Patients received placebo capsules

Placebo

Eligibility Criteria

• Age: 60 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sriwijaya: lead
• Indonesia Endowment Fund for Education (LPDP), Ministry of Finance Republik of Indonesia: collaborator

Study Sites (1)

Universitas Sriwijaya

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (4)

• 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.

  PMID: 29805981 BACKGROUND

• 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.

  PMID: 28818994 BACKGROUND

• 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.

  PMID: 28225996 BACKGROUND

• 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.

  PMID: 35246243 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

diacerein

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. dr. Yulianto, SpPD, K-EMD

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: June 21, 2024
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

ID (1)