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
March 28, 2025 updated by: Yulianto Kusnadi, Universitas Sriwijaya
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
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]
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Sumatera
-
Palembang, South Sumatera, Indonesia, 30126
- Universitas Sriwijaya
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diacerein 50 mg capsules
The patients were given a capsule containing Diacerein 50 mg twice a day
|
The patients received diacerein capsules
|
|
Placebo Comparator: Placebo
Patients received placebo capsules
|
Patients received placebo capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
[Time frame: From enrollment to the end of the treatment at 12 weeks]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
[Time frame: From enrollment to the end of the treatment at 12 weeks]
|
|
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.
|
[Time frame: From enrollment to the end of the treatment at 12 weeks]
|
|
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.
|
[Time frame: From enrollment to the end of the treatment at 12 weeks]
|
|
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.
|
[Time frame: From enrollment to the end of the treatment at 12 weeks]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2024
Primary Completion (Actual)
November 8, 2024
Study Completion (Actual)
November 8, 2024
Study Registration Dates
First Submitted
March 28, 2025
First Submitted That Met QC Criteria
March 28, 2025
First Posted (Actual)
April 4, 2025
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
March 28, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DP0403/DXVIII0608/ETIK007/2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.