NCT02106104

Brief Summary

The aim of this study is to detail the (mechanisms underlying the) actions of the DPP-4 inhibitor linagliptin on the renal system in patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

2.1 years

First QC Date

March 28, 2014

Last Update Submit

May 16, 2016

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes mellitusDiabetic kidney diseaseDiabetic nephropathyRenoprotectionDPP-4 inhibitorsLinagliptinSU derivativesGlimepiride

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline following 8-week treatment with linagliptin vs glimepiride on fasting and postprandial renal hemodynamics, measured as GFR / ERPF (determined by inulin/para-aminohippuric-acid clearance)

    8 weeks

Secondary Outcomes (3)

  • Renal tubular function

    8 weeks

  • Renal damage, measured by urine biomarkers

    8 weeks

  • Blood Pressure and Heart Rate

    8 weeks

Other Outcomes (9)

  • Body anthropometrics: body weight, height, body mass index, waist circumference

    8 weeks

  • Body fat content

    8 weeks

  • Systemic hemodynamic variables (blood pressure, heart rate, stroke volume, cardiac output/-index, total systemic vascular resistance)

    8 weeks

  • +6 more other outcomes

Study Arms (2)

Linagliptin 5 mg QD (N=24)

EXPERIMENTAL

Linagliptin 5 mg will be taken orally, once daily for 8 weeks

Drug: Linagliptin 5 mg QD (N=24)

Glimepiride 1 mg QD (N=24)

ACTIVE COMPARATOR

Glimepiride 1 mg will be taken orally, once daily for 8 weeks

Drug: Glimepiride 1 mg QD (N=24)

Interventions

Linagliptin 5 mg QD (N=24)DRUG

Linagliptin 5 mg will be taken orally, once daily for 8 weeks

Also known as: Trajenta
Linagliptin 5 mg QD (N=24)
Glimepiride 1 mg QD (N=24)DRUG

Glimepiride 1 mg will be taken orally, once daily for 8 weeks

Also known as: Amaryl
Glimepiride 1 mg QD (N=24)

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes (HbA1c: 6.5-9.0% DCCT or 48-75 mmol/mol IFCC)
  • Both genders (females must be post-menopausal)
  • Caucasian
  • Age: 35-75 years
  • Body Mass Index: \>25 kg/m2
  • All patients with previously diagnosed hypertension should use a RAS-interfering agent (angiotensin converting enzyme inhibitor/angiotensin II receptor blocker) for at least 3 months

You may not qualify if:

  • Current / chronic use of the following medication: thiazolidinediones, insulin, glucocorticoids, immune suppressants, antimicrobial agents or chemotherapeutics. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study
  • Chronic use of NSAIDs will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications. However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing
  • Pregnancy
  • Frequent occurrence of (confirmed) hypoglycemia (plasma glucose \<3.9 mmol/L)
  • Estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
  • Current urinary tract infection and active nephritis
  • Recent (\<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke, transient ischemic neurologic disorder
  • Complaints compatible with or established gastroparesis and/or neurogenic bladder
  • Active liver disease
  • History of or actual pancreatic disease
  • History of or actual malignancy (except for basal cell carcinoma)
  • History of or actual severe mental disease
  • Substance abuse (alcohol: defined as \>4 units/day; smoking/nicotine: defined as daily smoking/use)
  • Allergy to any of the agents used in the study
  • Inability to understand the study protocol or give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (1)

  • Muskiet MHA, Tonneijck L, Smits MM, Kramer MHH, Ouwens DM, Hartmann B, Holst JJ, Touw DJ, Danser AHJ, Joles JA, van Raalte DH. Effects of DPP-4 Inhibitor Linagliptin Versus Sulfonylurea Glimepiride as Add-on to Metformin on Renal Physiology in Overweight Patients With Type 2 Diabetes (RENALIS): A Randomized, Double-Blind Trial. Diabetes Care. 2020 Nov;43(11):2889-2893. doi: 10.2337/dc20-0902. Epub 2020 Sep 8.

    PMID: 32900785DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic Nephropathies

Interventions

Linagliptinglimepiride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Mark Kramer, MD PhD

    Amsterdam UMC, location VUmc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 8, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

NL(1)