Diabetes Mellitus, Type 2Phase 3DGCLFT2DMNCT02242149
Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
A Phase 3 study testing Diacerein in people with Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults treatment with diacerein will improve glycemic control and will reduce liver fat within a 24 month period. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
- 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
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Oct 2014to 31 Jan 2018
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes.
- Presence of liver steatosis diagnosed by ultrasound or transient elastography (Fibroscan®)
- Age 30-75 years.
- HbA1c 7.5- 9.5 for at least 8 weeks prior to screening.
- Stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents with or without insulin for 8 weeks prior to randomization.
Who cannot join
- Body mass index > 40 kg/m2
- Serum creatinine ≥180mmol/L or estimated glomerular filtration rate < 30 ml/min.
- Presence of any serious concomitant disease, such as a pulmonary disease or malignant disorders.
- Current daily alcohol ingestion ≥20 g.
- Hepatotoxic drugs.
- Presence of other chronic liver disease other than nonalcoholic fatty liver disease, including hepatitis B virus and hepatitis C virus infection, hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, autoimmune hepatitis.
- Women seeking pregnancy.
- Current use or previous use within 6 months of vitamin E or pioglitazone
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Program of Arterial Hypertension, University Hospital Clementino Fraga Filho
Rio de Janeiro, 21941913
About this study
This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults treatment with diacerein will improve glycemic control and will reduce liver fat within a 24 month period.
Read the detailed description
Background: Recently, knowledge about diacerhein, an anthraquinone drug with powerful anti-inflammatory properties, revealed that this drug improves insulin sensitivity, mediated by the reversal of chronic subclinical inflammation. Amongst the numerous pathogenetic factors, oxidative stress and apoptosis of hepatocytes initiate many inflammatory processes and are involved in the progression of Non alcoholic fatty liver disease.
Aims:The aim is to evaluate the effect of treatment with diacerein in improvement of glycemic parameters (mean glycated hemoglobin, fasting blood sugar) and reduction of liver fat fraction.
Methods:Two-hundred patients will be randomly allocated either to treatment with diacerein plus their usual therapeutic regimen or to placebo for 24 months. Clinic, laboratory evaluation (including glycated hemoglobin, fasting blood sugar, creatinine, ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyl transpeptidase, alkaline phosphatase, bilirubin, albumin, prothrombin time, platelet count, total cholesterol, high-density and low-density lipoprotein cholesterol and triglycerides and urinary albumin excretion rate no 24-hour urine collection) will be performed before and every 3 months until the end of study. Pro-Inflammatory cytokines, adiponectin and cytokeratin-18 were measured before, at 12 months and at the end of study. Liver fat fraction measurement using controlled attenuation parameter (CAP) by transient elastography. (Fibroscan) will be performed before and after the 12 and 24-month treatment, with the observers blinded to the allocation group.
- Being tested
- Diacerein, Placebo
- Keywords
- Fat liver, Diabetes, Diacerein, Transient elastography, Treatment
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Fatty Liver, 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, Artifit, Acert
All subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy.
PlaceboDrug
Sugar pill manufactured to mimic Diacerein
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | All subjects will be given placebo identically matched with regard to shape, color and taste. They will be given one tablet/day for 2 weeks and then two tablets/day for the duration of sudy. Receives: Drug: Placebo |
| Diacerein | Experimental | All subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy. Receives: Drug: Diacerein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of improvement in glycemic control and improvement in liver steatosis
Reduction of mean glycated hemoglobin (≥ 1%) and reduction of liver fat fraction as measured by transient elastography (≥ 20%)
Measured: Within 12 and 24 months
Secondary outcomes (2)
Improvement of microalbuminuria
Reduction of albumin excretion rate on 24-hour urine collection
Measured: Within 24 months
Changes of adipocytokines and cytokeratin-18
Elevation of high molecular weight adiponectin and reduction of the apoptotic by-product cytokeratin (CK)-18
Measured: Within 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study start14 Oct 2014
- Primary completion31 Jan 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Gil Fernando da Costa Mendes de Salles, PhD, Universidade Federal do Rio de Janeiro
- Investigators
- Gil F Salles, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242149
- Sponsor's protocol ID
- 30194914.3.0000.5257
- Acronym
- DGCLFT2DM
- Status last verified
- May 2018
- First submitted
- 14 Sep 2014
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cardoso CRL, Leite NC, Carlos FO, Loureiro AA, Viegas BB, Salles GF. Efficacy and Safety of Diacerein in Patients With Inadequately Controlled Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Oct;40(10):1356-1363. doi: 10.2337/dc17-0374. Epub 2017 Aug 17.
PubMed 28818994
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
- ClinicalTrials.gov ID
- NCT02242149
- Acronym / sponsor ID
- DGCLFT2DM / 30194914.3.0000.5257
- Keywords
- Fat liver, Diabetes, Diacerein, Transient elastography, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 16 Sep 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.
This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults treatment with diacerein will improve glycemic control and will reduce liver fat within a 24 month period.
Detailed description
Background: Recently, knowledge about diacerhein, an anthraquinone drug with powerful anti-inflammatory properties, revealed that this drug improves insulin sensitivity, mediated by the reversal of chronic subclinical inflammation. Amongst the numerous pathogenetic factors, oxidative stress and apoptosis of hepatocytes initiate many inflammatory processes and are involved in the progression of Non alcoholic fatty liver disease.
Aims:The aim is to evaluate the effect of treatment with diacerein in improvement of glycemic parameters (mean glycated hemoglobin, fasting blood sugar) and reduction of liver fat fraction.
Methods:Two-hundred patients will be randomly allocated either to treatment with diacerein plus their usual therapeutic regimen or to placebo for 24 months. Clinic, laboratory evaluation (including glycated hemoglobin, fasting blood sugar, creatinine, ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyl transpeptidase, alkaline phosphatase, bilirubin, albumin, prothrombin time, platelet count, total cholesterol, high-density and low-density lipoprotein cholesterol and triglycerides and urinary albumin excretion rate no 24-hour urine collection) will be performed before and every 3 months until the end of study. Pro-Inflammatory cytokines, adiponectin and cytokeratin-18 were measured before, at 12 months and at the end of study. Liver fat fraction measurement using controlled attenuation parameter (CAP) by transient elastography. (Fibroscan) will be performed before and after the 12 and 24-month treatment, with the observers blinded to the allocation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAll subjects will be given placebo identically matched with regard to shape, color and taste. They will be given one tablet/day for 2 weeks and then two tablets/day for the duration of sudy. |
| Diacerein | Experimental | Drug: DiacereinAll subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes.
- Presence of liver steatosis diagnosed by ultrasound or transient elastography (Fibroscan®)
- Age 30-75 years.
- HbA1c 7.5- 9.5 for at least 8 weeks prior to screening.
- Stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents with or without insulin for 8 weeks prior to randomization.
Key exclusion criteria (8 listed)
- Body mass index > 40 kg/m2
- Serum creatinine ≥180mmol/L or estimated glomerular filtration rate < 30 ml/min.
- Presence of any serious concomitant disease, such as a pulmonary disease or malignant disorders.
- Current daily alcohol ingestion ≥20 g.
- Hepatotoxic drugs.
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, Artifit, AcertAll subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy. | Drug | Diacerein |
| PlaceboSugar pill manufactured to mimic Diacerein | Drug | Placebo |
Primary outcome
Evidence of improvement in glycemic control and improvement in liver steatosis
Time frame: Within 12 and 24 months
Reduction of mean glycated hemoglobin (≥ 1%) and reduction of liver fat fraction as measured by transient elastography (≥ 20%)
2 secondary outcomes
Improvement of microalbuminuria
Time frame: Within 24 months
Changes of adipocytokines and cytokeratin-18
Time frame: Within 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Derived from this study: PubMed 28818994Cardoso CRL, Leite NC, Carlos FO, Loureiro AA, Viegas BB, Salles GF. Efficacy and Safety of Diacerein in Patients With Inadequately Controlled Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Oct;40(10):1356-1363. doi: 10.2337/dc17-0374. Epub 2017 Aug 17.
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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.
Gil F Salles, PhD principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diacerein in people with Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease, run by Universidade Federal do Rio de Janeiro at 1 site 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 8 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: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of improvement in glycemic control and improvement in liver steatosis (time frame: Within 12 and 24 months). 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 NCT02242149, which also lists 1 linked publication.
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 3 May 2018.