Diabetes Mellitus, Type 2Phase 3DiaKidZNCT04589351
Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe
A Phase 3 study testing Ezetimibe 10mg in people with Diabetes Mellitus, Type 2 and Diabetic Kidney Disease, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
In this study, we seek to explore the importance of fat accumulation in the kidneys in relation to diabetic kidney disease (DKD). To do this, we conduct an intervention trial in individuals with type 2 diabetes (T2D) and DKD where we investigate whether the inhibition of intestinal cholesterol absorption with… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Kidney Disease
- What is being tested?
- Ezetimibe 10mg
- 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
- 1 siteDenmark
- Study dates
- 1 Oct 2020to May 2022
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 40 and ≤ 75 years
- T2D (World Health Organization criteria)
- eGFR ≥ 30ml/min/1,73m2 at screening
- Persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months)
- LDL > 1.5mmol/L at screening
- Ability to communicate with the investigator and give informed consent
Who cannot join
- Chronic kidney disease primarily ascribed to other causes than diabetes
- Acute kidney disease within 3 months
- No UACR ≥ 3000mg/g in history
- Current or recent (within 3 months) treatment with ezetimibe
- Initiation or adjustment in dosage within 1 month of an angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor blocker (ARB), glucagon-like peptide-1 receptor (GLP-1RA) agonists, sodium-glucose cotransporter 2 (SGLT-2) inhibitors or anti-dyslipidemia drug, e.g. a statin
- Any contraindication to MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination, claustrophobia or body size not compatible with the scanner)
Show all 54Show fewer
- Intolerance to trial drug components
- Any previous major organ transplantation
- Elective major surgery during the trial
- Pregnancy, planned pregnancy or breastfeeding during the trial
- Insufficient contraception during the trial in women of childbearing potential
- Severe alcohol consumption or abuse of recreational drugs
- Moderate to severe liver failure (Child Pugh 7-15)
- Any surgical or medical condition which can be expected to significantly alter the absorption of the trial drug (e.g. major gastrointestinal tract surgery or inflammatory bowel disease)
- Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
- Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the trial
- Any reason for suspecting a considerable lack of compliance to the trial
- Inclusion criteria for the control group (cross-sectional study alone):
- Age ≥ 40 and ≤ 75 years
- eGFR ≥60ml/min/1,73m2 at screening
- Ability to communicate with the investigator and give informed consent
- Exclusion criteria for the control group (cross-sectional study alone):
- Any major chronic disease, e.g. diabetes mellitus, chronic kidney disease, ischemic heart disease, chronic obstructive pulmonary disease (this criterium does not include conditions that may be considered risk factors for chronic diseases, e.g. essential hypertension, primary hypercholesterolemia)
- Acute kidney disease within 3 months
- History of persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months including those at screening) or a previous diagnosis of micro- or macroalbuminuria
- Current or recent (within 3 months) treatment with ezetimibe
- Any contraindication to an MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination or claustrophobia)
- Any previous major organ transplantation
- Elective major surgery during the study
- Pregnancy, planned pregnancy or breastfeeding during the study
- Severe alcohol consumption or abuse of recreational drugs
- Moderate to severe liver failure (Child Pugh 7-15)
- Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
- Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the study
- Any reason for suspecting a considerable lack of compliance to the study
- Inclusion criteria for the group of participants with T2D and no DKD (cross-sectional study alone):
- Age ≥ 40 and ≤ 75 years
- T2D (World Health Organization criteria)
- eGFR ≥60ml/min/1,73m2 at screening
- Ability to communicate with the Investigator and give informed consent
- Exclusion criteria for the group of participants with T2D and no DKD (cross-sectional study alone):
- Any chronic kidney disease
- Acute kidney disease within 3 months
- History of persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months including those at screening) or a previous diagnosis of micro- or macroalbuminuria
- Current or recent (within 3 months) treatment with ezetimibe
- Any contraindication to an MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination or claustrophobia)
- Any previous major organ transplantation
- Elective major surgery during the study
- Pregnancy, planned pregnancy or breastfeeding during the study
- Severe alcohol consumption or abuse of recreational drugs
- Moderate to severe liver failure (Child Pugh 7-15)
- Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
- Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the study procedures
- Any reason for suspecting a considerable lack of compliance to the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Steno Diabetes Center Copenhagen
Gentofte Municipality, Capital Region, 2820
About this study
Official title: Kidney Fat in Type 2 Diabetes & Diabetic Kidney Disease and the Effects of Ezetimibe: A Cross-Sectional Study and Randomized, Placebo-Controlled Trial
In this study, we seek to explore the importance of fat accumulation in the kidneys in relation to diabetic kidney disease (DKD). To do this, we conduct an intervention trial in individuals with type 2 diabetes (T2D) and DKD where we investigate whether the inhibition of intestinal cholesterol absorption with ezetimibe affects albuminuria (a strong risk factor for diabetic complications) and kidney fat accumulation. At the same time and to confirm that kidney fat accumulation is, in fact, abnormal in T2D and DKD, we conduct a cross-sectional study in which we compare kidney fat accumulation in participants at baseline from the intervention trial with a group of individuals with T2D and no DKD and a group of healthy individuals.
Read the detailed description
Objective:
- To compare cross-sectionally the fractions of kidney lipid between controls, individuals with type 2 diabetes and no diabetic kidney disease and individuals with type 2 diabetes and non-severe diabetic kidney disease.
- To assess by intervention trial whether ezetimibe reduces albuminuria and kidney parenchymal triglyceride fraction in individuals with type 2 diabetes and non-severe diabetic kidney disease.
Design:
- Cross-sectional study on 30 controls, 30 individuals with type 2 diabetes and no diabetic kidney disease and 60 individuals with type 2 diabetes and non-severe diabetic kidney disease.
- Single-center, randomized, double-blinded, placebo-controlled and parallel intervention trial in 60 individuals with type 2 diabetes and non-severe diabetic kidney disease Comparative treatment regime: Ezetimibe 10mg per day versus placebo for 16 weeks Primary endpoint in cross-sectional study:
- Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy) Primary endpoint in intervention trial:
- Urinary albumin creatinine ratio Secondary endpoint in intervention trial:
- Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy) Main eligibility criteria for control group (cross-sectional study alone):
- Age 40-75 years
- No diabetes mellitus
- No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g
- No contraindication to examination by magnetic resonance Main eligibility criteria for group of individuals with type 2 diabetes and no diabetic kidney disease (cross-sectional study alone):
- Age 40-75 years
- Type 2 diabetes
- No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g
- No contraindication to examination by magnetic resonance Main eligibility criteria for group of individuals with type 2 diabetes and non-severe diabetic kidney disease (intervention trial):
- Age 40-75 years
- Type 2 diabetes
- Estimated glomerular filtration rate ≥30ml/min/1,73m2
- Urinary albumin creatinine ratio ≥ 30mg/g
- No contraindication to examination by magnetic resonance Recruitment
- Controls are recruited via announcements on relevant websites and, if necessary, in newspapers
- Individuals with type 2 diabetes are primarily recruited from the ambulatory at Steno Diabetes Center Copenhagen
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Kidney Disease
- Being tested
- Ezetimibe 10mg, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe 10mgDrug
Ezetimibe is a cholesterol absorption inhibitor with marketing approval. The recommended dose as per label is 10mg once a day.
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe | Active comparator | One treatment period of 16 weeks with1 capsule of ezetimibe 10mg per day, as add-on to standard care. Receives: Drug: Ezetimibe 10mg |
| Placebo | Placebo comparator | One treatment period of 16 weeks with 1 capsule of matching placebo per day, as add-on to standard care. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary albumin creatinine ratio (UACR)
Measured: Change over 16 weeks of treatment
Secondary outcomes (1)
Magnetic resonans estimate of kidney parenchymal triglyceride fraction
Measured: Change over 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Oct 2020
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- This study consists of a cross-sectional study and an intervention trial. The latter is a single-center, randomized, double-blinded, placebo-controlled and parallel trial in participants with T2D and non-severe diabetic kidney disease. Trial participants (n=60), by virtue of their baseline examinations (e.g. MR-examinations), also participate in the cross-sectional part of this study where they constitute one of three groups. The other two groups contain controls (n=30) and individuals with T2D and no diabetic kidney disease (n=30).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Aalborg University Hospital, Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark, Alessia Fornoni, MD PhD, Professor of Medicine, Chief, Katz Family Division of Nephrology and Hypertension
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589351
- Sponsor's protocol ID
- 16032020
- Other IDs
- 2020-001155-40
- Acronym
- DiaKidZ
- Status last verified
- Jan 2022
- First submitted
- 2 Oct 2020
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Fat in Type 2 Diabetes & Diabetic Kidney Disease and the Effects of Ezetimibe: A Cross-Sectional Study and Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04589351
- Acronym / sponsor ID
- DiaKidZ / 16032020
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Aalborg University Hospital, Capital Region's Pharmacy (Region Hovedstadens Apotek), Marielundvej 25, 2730 Herlev, Denmark, Alessia Fornoni, MD PhD, Professor of Medicine, Chief, Katz Family Division of Nephrology and Hypertension
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 19 Oct 2020 (actual)
- 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.
In this study, we seek to explore the importance of fat accumulation in the kidneys in relation to diabetic kidney disease (DKD). To do this, we conduct an intervention trial in individuals with type 2 diabetes (T2D) and DKD where we investigate whether the inhibition of intestinal cholesterol absorption with ezetimibe affects albuminuria (a strong risk factor for diabetic complications) and kidney fat accumulation. At the same time and to confirm that kidney fat accumulation is, in fact, abnormal in T2D and DKD, we conduct a cross-sectional study in which we compare kidney fat accumulation in participants at baseline from the intervention trial with a group of individuals with T2D and no DKD and a group of healthy individuals.
Detailed description
Objective:
- To compare cross-sectionally the fractions of kidney lipid between controls, individuals with type 2 diabetes and no diabetic kidney disease and individuals with type 2 diabetes and non-severe diabetic kidney disease.
- To assess by intervention trial whether ezetimibe reduces albuminuria and kidney parenchymal triglyceride fraction in individuals with type 2 diabetes and non-severe diabetic kidney disease.
Design:
- Cross-sectional study on 30 controls, 30 individuals with type 2 diabetes and no diabetic kidney disease and 60 individuals with type 2 diabetes and non-severe diabetic kidney disease.
- Single-center, randomized, double-blinded, placebo-controlled and parallel intervention trial in 60 individuals with type 2 diabetes and non-severe diabetic kidney disease Comparative treatment regime: Ezetimibe 10mg per day versus placebo for 16 weeks Primary endpoint in cross-sectional study:
- Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy) Primary endpoint in intervention trial:
- Urinary albumin creatinine ratio Secondary endpoint in intervention trial:
- Kidney parenchymal triglyceride fraction (estimated by magnetic resonance spectroscopy) Main eligibility criteria for control group (cross-sectional study alone):
- Age 40-75 years
- No diabetes mellitus
- No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g
- No contraindication to examination by magnetic resonance Main eligibility criteria for group of individuals with type 2 diabetes and no diabetic kidney disease (cross-sectional study alone):
- Age 40-75 years
- Type 2 diabetes
- No kidney disease or urinary albumin creatinine ratio ≥ 30mg/g
- No contraindication to examination by magnetic resonance Main eligibility criteria for group of individuals with type 2 diabetes and non-severe diabetic kidney disease (intervention trial):
- Age 40-75 years
- Type 2 diabetes
- Estimated glomerular filtration rate ≥30ml/min/1,73m2
- Urinary albumin creatinine ratio ≥ 30mg/g
- No contraindication to examination by magnetic resonance Recruitment
- Controls are recruited via announcements on relevant websites and, if necessary, in newspapers
- Individuals with type 2 diabetes are primarily recruited from the ambulatory at Steno Diabetes Center Copenhagen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study consists of a cross-sectional study and an intervention trial. The latter is a single-center, randomized, double-blinded, placebo-controlled and parallel trial in participants with T2D and non-severe diabetic kidney disease. Trial participants (n=60), by virtue of their baseline examinations (e.g. MR-examinations), also participate in the cross-sectional part of this study where they constitute one of three groups. The other two groups contain controls (n=30) and individuals with T2D and no diabetic kidney disease (n=30).
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe | Active comparator | Drug: Ezetimibe 10mgOne treatment period of 16 weeks with1 capsule of ezetimibe 10mg per day, as add-on to standard care. |
| Placebo | Placebo comparator | Drug: PlaceboOne treatment period of 16 weeks with 1 capsule of matching placebo per day, as add-on to standard care. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 40 and ≤ 75 years
- T2D (World Health Organization criteria)
- eGFR ≥ 30ml/min/1,73m2 at screening
- Persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months)
- LDL > 1.5mmol/L at screening
Key exclusion criteria (54 listed)
- Chronic kidney disease primarily ascribed to other causes than diabetes
- Acute kidney disease within 3 months
- No UACR ≥ 3000mg/g in history
- Current or recent (within 3 months) treatment with ezetimibe
- Initiation or adjustment in dosage within 1 month of an angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor blocker (ARB), glucagon-like peptide-1 receptor (GLP-1RA) agonists, sodium-glucose cotransporter 2 (SGLT-2) inhibitors or anti-dyslipidemia drug, e.g. a statin
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 |
|---|---|---|
| Ezetimibe 10mgEzetimibe is a cholesterol absorption inhibitor with marketing approval. The recommended dose as per label is 10mg once a day. | Drug | Ezetimibe |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Urinary albumin creatinine ratio (UACR)
Time frame: Change over 16 weeks of treatment
1 secondary outcome
Magnetic resonans estimate of kidney parenchymal triglyceride fraction
Time frame: Change over 16 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ezetimibe 10mg in people with Diabetes Mellitus, Type 2 and Diabetic Kidney Disease, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 6 inclusion and 54 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 18 Jan 2022. 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 Denmark. 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?
Results are not available in the source record.
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?
Urinary albumin creatinine ratio (UACR) (time frame: Change over 16 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2022.