Diacerein on Insulin Secretion in Diabetes
Primary Purpose
Type 2 Diabetes Mellitus, Overweight, Obesity
Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Diacerein
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, Overweight, Obesity
Eligibility Criteria
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.
Sites / Locations
- Unidad de Investigación Médica en Epidemiología Clínica
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diacerein
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Fasting insulin concentration
Fasting glucose concentration
A1C concentration
First phase of insulin secretion
Late phase of insulin secretion
Total insulin secretion concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT01298882
First Posted
January 31, 2011
Last Updated
February 16, 2011
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
National Council of Science and Technology, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT01298882
Brief Title
Diacerein on Insulin Secretion in Diabetes
Official Title
Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
National Council of Science and Technology, Mexico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight, Obesity
Keywords
Type 2 diabetes mellitus, Overweight, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
8. Arms, Groups, and Interventions
Arm Title
Diacerein
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diacerein
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Fasting insulin concentration
Time Frame
2 mo
Title
Fasting glucose concentration
Time Frame
2 mo
Title
A1C concentration
Time Frame
2 mo
Title
First phase of insulin secretion
Time Frame
2 mo
Title
Late phase of insulin secretion
Time Frame
2 mo
Title
Total insulin secretion concentration
Time Frame
2 mo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Unidad de Investigación Médica en Epidemiología Clínica
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44380
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
21610123
Citation
Ramos-Zavala MG, Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Gonzalez-Lopez R, Santiago-Hernandez NJ. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care. 2011 Jul;34(7):1591-4. doi: 10.2337/dc11-0357. Epub 2011 May 24.
Results Reference
derived
Learn more about this trial
Diacerein on Insulin Secretion in Diabetes
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