Diabetes-Related ComplicationsPhase 2NCT02177643
Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin
A Phase 2 study testing Diacerein in people with Diabetes-Related Complications and Diabetes Mellitus, Type 2, run by University of Campinas, Brazil at 3 sites in Brazil.
Trial summary
Considering that, Diacerein is on the market for almost 20 years, being used continuously in elderly patients with osteoarthritis without present significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes and in a… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes-Related Complications, Diabetes Mellitus, Type 2, Insulin Resistance
- What is being tested?
- Diacerein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2013to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus (DM) type 2 between 6 months to 10 years of disease
- Body mass index between 25 and 35 kg/m2
- Fasting glucose between 120 and 250 mg/dL
- Glycated Hb A1c greater than 7,5 %
- Taking Metformin (dose above 1700 mg/day) with or without other secretagogue.
Who cannot join
- Subjects with DM1
- Subjects with DM2 using insulin
- Subjects with DM2 with chronic complications that already have clinical consequences
- Subjects with other types of diabetes
- Creatinine serum greater than 1.4 mg/dl (female) and 1.5 mg/dl (male)
- History of heart disease and/or severe concomitant diseases such as liver, coronary artery, renal
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- History of severe psychiatric or neurological disorders
- History of alcohol abuse and/or illegal drugs or psychotropic medicines in the past six months
- Hypersensitivity to any component of the of study drug and placebo formulation.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites, 3 recruiting
- Recruiting
Universidade Estadual de Campinas
Campinas, São Paulo
Dra. Maria Cândida R. Parisi, PhD, +55 (019) 98196-2242, emaildacandida@uol.com.br
Dr. Daniel Minuti, MD Msc, +55 (019) 98128-2535, danielminutti@yahoo.com.br
- Recruiting
Universidade Estadual de Feira de Santana
Feira de Santana, Estado de Bahia
Dra. Ana Mayra A. Oliveira, PhD, +55 (075) 3625-4027, anamayra@uol.com.br
Dra. Ana Mayra A. Oliveira, PhD
- Recruiting
Centro de Estudos em Diabetes e Hipertensão
Fortaleza, Ceará
Dra. Adriana C. Forti, PhD, +55 (085) 3105-8300, cedh@cedh.med.br
Dra. Adriana C. Forti, PhD
About this study
Official title: Effect of Diacerein in the Metabolic Control of Patients With Diabetes Mellitus Type 2 and Secondary Failure to Metformin
Considering that, Diacerein is on the market for almost 20 years, being used continuously in elderly patients with osteoarthritis without present significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes and in a previously study from Mexico. The aim of our study is to investigate the effect of Diacerein, a medication with anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.
Read the detailed description
This proof of concept study aims to access the metabolic control in patients with type 2 diabetes mellitus and secondary failure to metformin.
The Study is a Phase II, Multicenter, National, Prospective, Randomized, Double blind, Parallel Groups, Placebo Comparative Trial. UNICAMP (Hospital of Unicamp) is the coordinating center and we have the participation of the State University of Feira de Santana and the Center for Diabetes and Hypertension in Fortaleza.
Study Objectives: To investigate the effect of Diacerein administered for 12 weeks; glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment. The Total Number of patients will be approximately 60, 30 patients in each group.
- Being tested
- Diacerein, Placebo
- Keywords
- Diabetes, Diacerein
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus, Type 2, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiacereinDrug
Also called Artrodar - TRB Pharma
Diacerein oral capsules
PlaceboDrug
Placebo oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Diacerein | Active comparator | Diacerein 50 mg immediate release capsule, once daily for the starting 28 days and Diacerein 50 mg immediate release capsule twice a day for the remains of the study. Receives: Drug: Diacerein |
| Placebo | Placebo comparator | Placebo capsules once a day for the starting 28 days and two times daily for the remainder of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Glucose Concentration
Measured: Baseline, 12 weeks
Fasting Insulin Concentration
Measured: Baseline, 12 weeks
HbA1c - glycated haemoglobin
Measured: Baseline, 12 weeks
Inflammatory Activity Profile
TNFα IL6 IL1β C-Reactive Protein (CRP)
Measured: Baseline, 12 weeks
Lipid Panel
Measured: Baseline, 12 weeks
Hepatic Function Panel
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes-Related ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, ANS Pharma
- Responsible party
- Principal investigator, Aleksandra Alves Silva, University of Campinas, Brazil
- Investigators
- Dr. Mario JA Saad, MD PhD, Study director, National Institute of Science and Technology of Obesity and Diabetes (CNPq)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177643
- Sponsor's protocol ID
- 07943212.5.2002.0053
- Other IDs
- CAAE: 07943212.5.2002.0053
- Status last verified
- Sep 2015
- First submitted
- 23 Jun 2014
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21610123Tobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Prada PO, Saad MJ. Comment on: Ramos-Zavala et al. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care 2011;34:1591-1594. Diabetes Care. 2012 Feb;35(2):e13; author reply e14. doi: 10.2337/dc11-1856. No abstract available.
PubMed 22275450Tobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Santos-Silva JC, Zollner RL, Boechat LH, Carvalheira JB, Prada PO, Saad MJ. Diacerhein improves glucose tolerance and insulin sensitivity in mice on a high-fat diet. Endocrinology. 2011 Nov;152(11):4080-93. doi: 10.1210/en.2011-0249. Epub 2011 Sep 6.
PubMed 21896669Velloso LA, Folli F, Perego L, Saad MJ. The multi-faceted cross-talk between the insulin and angiotensin II signaling systems. Diabetes Metab Res Rev. 2006 Mar-Apr;22(2):98-107. doi: 10.1002/dmrr.611.
PubMed 16389635
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diacerein in the Metabolic Control of Patients With Diabetes Mellitus Type 2 and Secondary Failure to Metformin
- ClinicalTrials.gov ID
- NCT02177643
- Acronym / sponsor ID
- 07943212.5.2002.0053
- Keywords
- Diabetes, Diacerein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, ANS Pharma
- Study start
- Jan 2013
- Primary completion
- Aug 2016 (estimated)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Considering that, Diacerein is on the market for almost 20 years, being used continuously in elderly patients with osteoarthritis without present significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes and in a previously study from Mexico. The aim of our study is to investigate the effect of Diacerein, a medication with anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.
Detailed description
This proof of concept study aims to access the metabolic control in patients with type 2 diabetes mellitus and secondary failure to metformin.
The Study is a Phase II, Multicenter, National, Prospective, Randomized, Double blind, Parallel Groups, Placebo Comparative Trial. UNICAMP (Hospital of Unicamp) is the coordinating center and we have the participation of the State University of Feira de Santana and the Center for Diabetes and Hypertension in Fortaleza.
Study Objectives: To investigate the effect of Diacerein administered for 12 weeks; glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment. The Total Number of patients will be approximately 60, 30 patients in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diacerein | Active comparator | Drug: DiacereinDiacerein 50 mg immediate release capsule, once daily for the starting 28 days and Diacerein 50 mg immediate release capsule twice a day for the remains of the study. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules once a day for the starting 28 days and two times daily for the remainder of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes mellitus (DM) type 2 between 6 months to 10 years of disease
- Body mass index between 25 and 35 kg/m2
- Fasting glucose between 120 and 250 mg/dL
- Glycated Hb A1c greater than 7,5 %
- Taking Metformin (dose above 1700 mg/day) with or without other secretagogue.
Key exclusion criteria (9 listed)
- Subjects with DM1
- Subjects with DM2 using insulin
- Subjects with DM2 with chronic complications that already have clinical consequences
- Subjects with other types of diabetes
- Creatinine serum greater than 1.4 mg/dl (female) and 1.5 mg/dl (male)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiacereinAlso: Artrodar - TRB PharmaDiacerein oral capsules | Drug | Diacerein |
| PlaceboPlacebo oral capsules | Drug | Placebo |
Primary outcome
Fasting Glucose Concentration
Time frame: Baseline, 12 weeks
Fasting Insulin Concentration
Time frame: Baseline, 12 weeks
HbA1c - glycated haemoglobin
Time frame: Baseline, 12 weeks
Inflammatory Activity Profile
Time frame: Baseline, 12 weeks
TNFα IL6 IL1β C-Reactive Protein (CRP)
Lipid Panel
Time frame: Baseline, 12 weeks
Hepatic Function Panel
Time frame: Baseline, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Background: PubMed 21610123Ramos-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.
- Background: PubMed 22275450Tobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Prada PO, Saad MJ. Comment on: Ramos-Zavala et al. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care 2011;34:1591-1594. Diabetes Care. 2012 Feb;35(2):e13; author reply e14. doi: 10.2337/dc11-1856. No abstract available.
- Background: PubMed 21896669Tobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Santos-Silva JC, Zollner RL, Boechat LH, Carvalheira JB, Prada PO, Saad MJ. Diacerhein improves glucose tolerance and insulin sensitivity in mice on a high-fat diet. Endocrinology. 2011 Nov;152(11):4080-93. doi: 10.1210/en.2011-0249. Epub 2011 Sep 6.
- Background: PubMed 16389635Velloso LA, Folli F, Perego L, Saad MJ. The multi-faceted cross-talk between the insulin and angiotensin II signaling systems. Diabetes Metab Res Rev. 2006 Mar-Apr;22(2):98-107. doi: 10.1002/dmrr.611.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Mario JA Saad, MD PhD study director
National Institute of Science and Technology of Obesity and Diabetes (CNPq)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diacerein in people with Diabetes-Related Complications and Diabetes Mellitus, Type 2, run by University of Campinas, Brazil at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dra. Maria Cândida R. Parisi, PhD (+55 (019) 981962242, emaildacandida@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Glucose Concentration (time frame: Baseline, 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02177643, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.