Diacerein on Insulin Secretion in Diabetes
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|ClinicalTrials.gov Identifier: NCT01298882|
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : February 18, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Overweight Obesity||Drug: Diacerein Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity|
|Experimental: Diacerein||Drug: Diacerein|
|Placebo Comparator: Placebo||Other: Placebo|
- Fasting insulin concentration [ Time Frame: 2 mo ]
- Fasting glucose concentration [ Time Frame: 2 mo ]
- A1C concentration [ Time Frame: 2 mo ]
- First phase of insulin secretion [ Time Frame: 2 mo ]
- Late phase of insulin secretion [ Time Frame: 2 mo ]
- Total insulin secretion concentration [ Time Frame: 2 mo ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298882
|Unidad de Investigación Médica en Epidemiología Clínica|
|Guadalajara, Jalisco, Mexico, 44380|