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Diacerein on Insulin Secretion in Diabetes

Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01298882
Enrollment
Unknown
Registered
2011-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2011-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus, Overweight, Obesity

Keywords

Type 2 diabetes mellitus, Overweight, Obesity

Brief summary

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.

Interventions

DRUGDiacerein
OTHERPlacebo

Sponsors

National Council of Science and Technology, Mexico
CollaboratorOTHER
Coordinación de Investigación en Salud, Mexico
Lead SponsorOTHER_GOV

Study design

Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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

Exclusion criteria

* Personal history of hepatic, renal or coronary artery disease * Medications known to affect metabolism during the previous 6 months.

Design outcomes

Primary

MeasureTime frame
Fasting insulin concentration2 mo
Fasting glucose concentration2 mo
A1C concentration2 mo
First phase of insulin secretion2 mo
Late phase of insulin secretion2 mo
Total insulin secretion concentration2 mo

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026