Diacerein on Insulin Secretion in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα) inhibition with diacerein administration on insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.

Hypothesis. Diacerein administration improves insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.

Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial. Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15 days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed rank and Mann-Whitney U test.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of CT-868 in Type 1 Diabetes Mellitus

NCT06062069

Overweight Obese Type 1 Diabetes Mellitus

COMPLETED PHASE2

Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes

NCT01140893

Type 2 Diabetes

UNKNOWN PHASE2/PHASE3

Treatment of Patients With Type 2 Diabetes With an Interleukin-1 Antagonist

NCT00303394

Type 2 Diabetes

COMPLETED PHASE2

Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes

NCT00511602

Type 2 Diabetes Mellitus

COMPLETED PHASE2

Subcutaneous Administration of Lisofylline to Healthy Normal Subjects and Subjects With Type 1 Diabetes

NCT00896077

Healthy Type 1 Diabetes

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus Overweight Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diacerein

Group Type EXPERIMENTAL

Diacerein

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diacerein

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fasting glucose levels between 7.0 and 11.1 mmol/L
* A1C levels between 7 and 9%
* Same residential area and socioeconomic status
* Excessively sedentary or participated in heavy physical activity
* Nonsmokers
* Body weight was stable for at least 3 months before the study
* Blood pressure was \<130/80 mm Hg