Type2 DiabetesPhase 4RACELINESNCT03433248
Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES
A Phase 4 study testing EMPA/LINA 10/5 mg QD (n=22), LINA/EMPA 5/10 mg QD (N=22) and Gliclazide 30 mg QD/BID (N=22) in people with Type2 Diabetes, run by M.H.H. Kramer at 1 site in Netherlands.
Trial summary
The current study aims to explore the clinical effects and mechanistics of mono- and combination therapy with SGLT-2 inhibitor empagliflozin and DPP-4 inhibitor linagliptin on renal physiology and biomarkers in metformin-treated T2DM patients. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- EMPA/LINA 10/5 mg QD (n=22), LINA/EMPA 5/10 mg QD (N=22) and Gliclazide 30 mg QD/BID (N=22)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Nov 2017to 1 Sep 2022
- Phase
- Phase 4
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caucasian*
- Both genders (females must be post-menopausal; no menses >1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as >31 U/L)
- Age: 35 - 75 years
- BMI: >25 kg/m2
- HbA1c: 7.0 - 9.5% Diabetes Control and Complications Trial (DCCT) or 53 - 80 mmol/mol International Federation of Clinical Chemistry (IFCC)
- Treatment with a stable dose of oral antihyperglycemic agents for at least 3 months prior to inclusion
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- Metformin monotherapy
- Combination of metformin and low-dose SU derivative**
- Hypertension should be controlled, i.e. ≤140/90 mmHg, and treated with an ACE-I or ARB (unless prevented by adverse effect) for at least 3 months.
- Albuminuria should be treated with a RAAS-interfering agent (ACE-I or ARB) for at least 3 months.
- Written informed consent
- In order to increase homogeneity ** In order to accelerate inclusion, patients using combined metformin/SU derivative will be considered. In these patients, a 12 week wash-out period of the SU derivative will be observed, only when combined use has led to a HbA1c <8% at screening. Subsequently, patients will be eligible to enter the study, now using metformin monotherapy, provided that HbA1c still meets inclusion criteria.
Who cannot join
- Estimated GFR <45 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
- Hemoglobin level < 7.0 mmol/L
- Current urinary tract infection and active nephritis
- History of unstable or rapidly progressing renal disease
- Macroalbuminuria; defined as ACR of >300 mg/g.
- Current/chronic use of the following medication: thiazolidinediones, sulfonylurea derivatives, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitor, oral glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MOAIs).
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- Patients on diuretics will only be excluded when these drugs cannot be stopped 3 months prior randomization and for the duration of the study.
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing
- Pregnancy
- History of or actual severe mental disease
- History of or actual severe somatic disease (e.g. systemic disease)
- History of or actual malignancy (except basal cell carcinoma)
- History of or actual pancreatic disease
- (Unstable) thyroid disease
- Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN)
- Recent (<6 months) history of cardiovascular disease, including
- Acute coronary syndrome
- Stroke or transient ischemic neurologic disorder or chronic heart failure (NYHA grade II-IV)
- Complaints compatible with or established neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
- Substance abuse (alcohol: defined as >3 units alcohol/day)
- History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
- Recent blood donation (< 6 months)
- Allergy to any of the agents used in the study
- Inability to understand the protocol and/or give informed consent
- Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University Medical Center
Amsterdam, North Holland, 1081HV
About this study
Official title: RACELINES: Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES
The current study aims to explore the clinical effects and mechanistics of mono- and combination therapy with SGLT-2 inhibitor empagliflozin and DPP-4 inhibitor linagliptin on renal physiology and biomarkers in metformin-treated T2DM patients.
Read the detailed description
Sodium-glucose linked transporters (SGLT-2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors are relatively novel glucose-lowering drugs for the treatment of T2DM. These agents seem to exert pleiotropic actions 'beyond glucose control'. SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular pressure and albuminuria in rodents and type 1 diabetes patients. In addition, SGLT-2 inhibitors reduce, blood pressure and body weight. In rodents, SGLT-2 inhibitors also improved histopathological abnormalities associated with DKD. DPP-4 inhibitors are considered weight neutral, improve lipid profiles and slight reductions in blood pressure have been reported. To date, the potential renoprotective effects and mechanisms of SGLT-2 inhibitors and combination therapy with SGLT-2 inhibitors have not been sufficiently detailed in human type 2 diabetes. The current study aims to explore the clinical effects and mechanistics of mono- and combination therapy with an SGLT-2 inhibitor and a DPP-4 inhibitor on renal physiology and biomarkers in metformin-treated T2DM patients.
66 patients with type 2 diabetes will undergo a 16-week intervention period with 8-week empagliflozin (SGLT-2 inhibitor) monotherapy, followed by 8-week empagliflozin and linagliptin (DPP-4 inhibitor) combination therapy or 8-week linagliptin monotherapy, followed by 8-week linagliptin and empagliflozin combination therapy or 8-week gliclazide (SU derivative), followed by 8-week gliclazide intensification therapy in order to assess changes in the outcome parameters.
- Conditions
- Type2 Diabetes
- Being tested
- EMPA/LINA 10/5 mg QD (n=22), LINA/EMPA 5/10 mg QD (N=22), Gliclazide 30 mg QD/BID (N=22)
- Keywords
- Type 2 diabetes mellitus, Diabetic kidney disease, Diabetic nephropathy, Renoprotection, SGLT2 inhibitor, Empagliflozin, DPP-4 inhibitor, Linagliptin, SU derivative, Gliclazide
- 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.
EMPA/LINA 10/5 mg QD (n=22)Drug
Also called Jardiance, Tradjenta
Once daily treatment with oral empagliflozin (Jardiance) 10 mg Once daily treatment with oral linagliptin (Tradjenta) 5 mg
LINA/EMPA 5/10 mg QD (N=22)Drug
Also called Tradjenta, Jardiance
Once daily treatment with oral linagliptin (Tradjenta) 5 mg Once daily treatment with oral empagliflozin (Jardiance) 10 mg
Gliclazide 30 mg QD/BID (N=22)Drug
Also called Gliclazide Sandoz
Once daily or twice daily treatment with oral glicazide MR 30mg
| Study group | Role | What they receive |
|---|---|---|
| EMPA/LINA 10/5 mg QD (n=22) | Experimental | 8w EMPA followed by 8w EMPA/LINA 10/5 mg QD (n=22) Receives: Drug: EMPA/LINA 10/5 mg QD (n=22); Drug: LINA/EMPA 5/10 mg QD (N=22) |
| LINA/EMPA 5/10 mg QD (N=22) | Experimental | 8w LINA followed by LINA/EMPA 5/10 mg QD (N=22) Receives: Drug: EMPA/LINA 10/5 mg QD (n=22); Drug: LINA/EMPA 5/10 mg QD (N=22) |
| Gliclazide 30 mg QD/BID (N=22) | Active comparator | 8w Gliclazide 30 mg QD, followed by 8w Gliclazide BID (N=22) Receives: Drug: Gliclazide 30 mg QD/BID (N=22) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR
Changes from baseline following 16-week treatment on renal hemodynamics in both the fasting and postprandial state, measured as GFR (determined by the inulin-clearance technique)
Measured: 16 weeks
GFR
Changes from baseline following 8-week treatment on renal hemodynamics in both the fasting and postprandial state, measured as GFR (determined by the inulin-clearance technique)
Measured: 8 weeks
Secondary outcomes (14)
Renal tubular function
24-hour urine sodium-, potassium-, chloride-, calcium-, magnesium-, phosphate-, uric acid-, bicarbonate-, ammonium-, urea- and glucose excretion, urine osmolality and urinary pH
Measured: 16 weeks
Renal tubular function
24-hour urine sodium-, potassium-, chloride-, calcium-, magnesium-, phosphate-, uric acid-, bicarbonate-, ammonium-, urea- and glucose excretion, urine osmolality and urinary pH
Measured: 8 weeks
Renal Damage
24-hour urinary albumin excretion, albumin/creatinine ratio (UCR)
Measured: 16 weeks
Renal Damage
24-hour urinary albumin excretion, albumin/creatinine ratio (UCR)
Measured: 10 weeks
Renal Damage
24-hour urinary albumin excretion, albumin/creatinine ratio (UCR)
Measured: 8 weeks
Renal Damage
24-hour urinary albumin excretion, albumin/creatinine ratio (UCR)
Measured: 2 weeks
Heart Rate (Dinamap®)
Measured using an automated oscillometric blood pressure device (Dinamap®)
Measured: 16 weeks
Heart Rate (Dinamap®)
Measured using an automated oscillometric blood pressure device (Dinamap®)
Measured: 10 weeks
Heart Rate (Dinamap®)
Measured using an automated oscillometric blood pressure device (Dinamap®)
Measured: 8 weeks
Heart Rate (Dinamap®)
Measured using an automated oscillometric blood pressure device (Dinamap®)
Measured: 2 weeks
Blood Pressure (Dinamap®)
Measured using an automated oscillometric blood pressure device (Dinamap®)
Measured: 16 weeks
Blood Pressure (Dinamap®)
Measured using an automated oscillometric blood pressure device (Dinamap®)
Measured: 10 weeks
Blood Pressure (Dinamap®)
Measured using an automated oscillometric blood pressure device (Dinamap®)
Measured: 8 weeks
Blood Pressure (Dinamap®)
Measured using an automated oscillometric blood pressure device (Dinamap®)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start9 Nov 2017
- Primary completion1 Jun 2021
- Study completion1 Sep 2022 (estimated)
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 Type2 DiabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.H.H. Kramer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, M.H.H. Kramer, Amsterdam UMC, location VUmc
- Investigators
- Mark HH Kramer, MD PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433248
- Sponsor's protocol ID
- DC2017RACELINES01
- Acronym
- RACELINES
- Status last verified
- Jan 2022
- First submitted
- 22 Nov 2017
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Baar MJB, Bjornstad P, Touw DJ, Joles JA, Krebber MM, Cherney DZI, van Raalte DH, Muskiet MHA. Renal functional reserve predicts GFR response to empagliflozin in RENALIS and RACELINES clinical trials. Nephrol Dial Transplant. 2026 Jul 31;41(8):1520-1528. doi: 10.1093/ndt/gfag025.
PubMed 41665872
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RACELINES: Renal Actions of Combined Empagliflozin and LINagliptin in Type 2 diabetES
- ClinicalTrials.gov ID
- NCT03433248
- Acronym / sponsor ID
- RACELINES / DC2017RACELINES01
- Conditions
- Type2 Diabetes
- Keywords
- Type 2 diabetes mellitus, Diabetic kidney disease, Diabetic nephropathy, Renoprotection, SGLT2 inhibitor, Empagliflozin, DPP-4 inhibitor, Linagliptin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- M.H.H. KramerUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 14 Feb 2018 (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.
The current study aims to explore the clinical effects and mechanistics of mono- and combination therapy with SGLT-2 inhibitor empagliflozin and DPP-4 inhibitor linagliptin on renal physiology and biomarkers in metformin-treated T2DM patients.
Detailed description
Sodium-glucose linked transporters (SGLT-2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors are relatively novel glucose-lowering drugs for the treatment of T2DM. These agents seem to exert pleiotropic actions 'beyond glucose control'. SGLT-2 inhibitors decrease proximal sodium reabsorption and decrease glomerular pressure and albuminuria in rodents and type 1 diabetes patients. In addition, SGLT-2 inhibitors reduce, blood pressure and body weight. In rodents, SGLT-2 inhibitors also improved histopathological abnormalities associated with DKD. DPP-4 inhibitors are considered weight neutral, improve lipid profiles and slight reductions in blood pressure have been reported. To date, the potential renoprotective effects and mechanisms of SGLT-2 inhibitors and combination therapy with SGLT-2 inhibitors have not been sufficiently detailed in human type 2 diabetes. The current study aims to explore the clinical effects and mechanistics of mono- and combination therapy with an SGLT-2 inhibitor and a DPP-4 inhibitor on renal physiology and biomarkers in metformin-treated T2DM patients.
66 patients with type 2 diabetes will undergo a 16-week intervention period with 8-week empagliflozin (SGLT-2 inhibitor) monotherapy, followed by 8-week empagliflozin and linagliptin (DPP-4 inhibitor) combination therapy or 8-week linagliptin monotherapy, followed by 8-week linagliptin and empagliflozin combination therapy or 8-week gliclazide (SU derivative), followed by 8-week gliclazide intensification therapy in order to assess changes in the outcome parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMPA/LINA 10/5 mg QD (n=22) | Experimental | Drug: EMPA/LINA 10/5 mg QD (n=22), Drug: LINA/EMPA 5/10 mg QD (N=22)8w EMPA followed by 8w EMPA/LINA 10/5 mg QD (n=22) |
| LINA/EMPA 5/10 mg QD (N=22) | Experimental | Drug: EMPA/LINA 10/5 mg QD (n=22), Drug: LINA/EMPA 5/10 mg QD (N=22)8w LINA followed by LINA/EMPA 5/10 mg QD (N=22) |
| Gliclazide 30 mg QD/BID (N=22) | Active comparator | Drug: Gliclazide 30 mg QD/BID (N=22)8w Gliclazide 30 mg QD, followed by 8w Gliclazide BID (N=22) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Caucasian*
- Both genders (females must be post-menopausal; no menses >1 year; in case of doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off defined as >31 U/L)
- Age: 35 - 75 years
- BMI: >25 kg/m2
- HbA1c: 7.0 - 9.5% Diabetes Control and Complications Trial (DCCT) or 53 - 80 mmol/mol International Federation of Clinical Chemistry (IFCC)
Key exclusion criteria (25 listed)
- Estimated GFR <45 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
- Hemoglobin level < 7.0 mmol/L
- Current urinary tract infection and active nephritis
- History of unstable or rapidly progressing renal disease
- Macroalbuminuria; defined as ACR of >300 mg/g.
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 |
|---|---|---|
| EMPA/LINA 10/5 mg QD (n=22)Also: Jardiance, TradjentaOnce daily treatment with oral empagliflozin (Jardiance) 10 mg Once daily treatment with oral linagliptin (Tradjenta) 5 mg | Drug | EMPA/LINA 10/5 mg QD (n=22), LINA/EMPA 5/10 mg QD (N=22) |
| LINA/EMPA 5/10 mg QD (N=22)Also: Tradjenta, JardianceOnce daily treatment with oral linagliptin (Tradjenta) 5 mg Once daily treatment with oral empagliflozin (Jardiance) 10 mg | Drug | EMPA/LINA 10/5 mg QD (n=22), LINA/EMPA 5/10 mg QD (N=22) |
| Gliclazide 30 mg QD/BID (N=22)Also: Gliclazide SandozOnce daily or twice daily treatment with oral glicazide MR 30mg | Drug | Gliclazide 30 mg QD/BID (N=22) |
Primary outcome
GFR
Time frame: 16 weeks
Changes from baseline following 16-week treatment on renal hemodynamics in both the fasting and postprandial state, measured as GFR (determined by the inulin-clearance technique)
GFR
Time frame: 8 weeks
Changes from baseline following 8-week treatment on renal hemodynamics in both the fasting and postprandial state, measured as GFR (determined by the inulin-clearance technique)
14 secondary outcomes
Renal tubular function
Time frame: 16 weeks
Renal tubular function
Time frame: 8 weeks
Renal Damage
Time frame: 16 weeks
Renal Damage
Time frame: 10 weeks
Renal Damage
Time frame: 8 weeks
Renal Damage
Time frame: 2 weeks
Heart Rate (Dinamap®)
Time frame: 16 weeks
Heart Rate (Dinamap®)
Time frame: 10 weeks
Heart Rate (Dinamap®)
Time frame: 8 weeks
Heart Rate (Dinamap®)
Time frame: 2 weeks
Blood Pressure (Dinamap®)
Time frame: 16 weeks
Blood Pressure (Dinamap®)
Time frame: 10 weeks
Blood Pressure (Dinamap®)
Time frame: 8 weeks
Blood Pressure (Dinamap®)
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 41665872van Baar MJB, Bjornstad P, Touw DJ, Joles JA, Krebber MM, Cherney DZI, van Raalte DH, Muskiet MHA. Renal functional reserve predicts GFR response to empagliflozin in RENALIS and RACELINES clinical trials. Nephrol Dial Transplant. 2026 Jul 31;41(8):1520-1528. doi: 10.1093/ndt/gfag025.
- Individual participant dataSharing planned: No
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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.
Mark HH Kramer, MD PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EMPA/LINA 10/5 mg QD (n=22), LINA/EMPA 5/10 mg QD (N=22) and Gliclazide 30 mg QD/BID (N=22) in people with Type2 Diabetes, run by M.H.H. Kramer at 1 site in Netherlands.
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 12 inclusion and 25 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 14 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 Netherlands. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
GFR (time frame: 16 weeks). The study lists 2 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 NCT03433248, 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 14 Jan 2022.