Antiproteinuric Effects of Liraglutide Treatment

NCT02545738 | Completed Phase 4 DMC

• 1 other identifier: 2014-004502-15
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the effect of Liraglutide on albuminuria in type 2 diabetes.

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Change in albuminuria

  24h urinary albumin excretion rate (UAER mg/24h)

  24 weeks

Secondary Outcomes (5)

• Change in renin-angiotensin system hormones

  24 weeks

• Change in kidney function

  24 weeks

• Change in 24h blood pressure

  24 weeks

• Change in markers of inflammation

  24 weeks

• 24h heart rate

  24 weeks

Study Arms (2)

Liraglutide

EXPERIMENTAL

Liraglutide s.c. up-escalated to 1.8 mg/day for 12 weeks.

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Placebo s.c. for 12 weeks.

Drug: placebo

Interventions

Liraglutide DRUG

active treatment

Also known as: Victoza

Liraglutide

placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must give written informed consent before participation. Patient information and consent form must be approved by the Danish Medicines Agency and the Regional Scientific Ethical Committee
• Male or female patients \>18 years with type 2 diabetes (WHO criteria).
• HbA1c ≥ 48 mmol/mol (6.5 %)
• eGFR ≥ 30 ml/min/1.73 m2 (estimated by MDRD formula)
• Fertile female patients must use chemical, hormonal or mechanical contraceptives or be in menopause (i.e. must not have had regular menstrual bleeding for at least one year) or have undergone bilateral oophorectomi or have been surgically sterilized or hysterectomised at least six months prior to screening
• Geometic mean urine albumin-to-creatinine ratio (UACR) above 30 mg/g at screening (measured in at least two of three consecutive morning spot urine samples)
• Systolic blood pressure (SBP) must be lower than 180 mm Hg at screening.
• Patients must be on stable glucose lowering medication for at least two weeks before the first visit.
• Must be able to communicate with the investigator.

You may not qualify if:

• SBP \> 180 mm Hg at screening
• Type 1 diabetes mellitus
• Chronic pancreatitis / previous acute pancreatitis
• Known or suspected hypersensitivity to trial product(s) or related products.
• Treatment with oral glucocorticoids, calcineurin inhibitors, dipeptidyl peptidase 4 (DPP4) inhibitors, glucagon like peptide-1 agonists and sodium-glucose co-transporter 2 (SGLT-2) inhibitors, which in the investigator's opinion could interfere with glucose or lipid metabolism 90 days prior to screening
• Cancer (except basal cell skin cancer or squamous cell skin cancer) or any other clinically significant disorder, except for conditions associated with type 2 diabetes history, which in the investigators opinion could interfere with the results of the trial
• Inflammatory bowel disease
• Cardiac disease defined as: Decompensated heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months
• Previous bowel resection
• Body mass index \<18.5 kg/m2
• Females of childbearing potential who are pregnant, breast-feeding, intending to become pregnant or not using adequate contraceptive methods
• Clinical signs of diabetic gastroparesis
• Impaired liver function (transaminases \> two times upper reference levels)
• The receipt of any investigational product 90 days prior to this trial
• Known or suspected abuse of alcohol or narcotics

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Peter Rossing

Gentofte Municipality, 2820, Denmark

Location

Related Publications (3)

• Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

  PMID: 39963952 DERIVED

• Wretlind A, Curovic VR, de Zawadzki A, Suvitaival T, Xu J, Zobel EH, von Scholten BJ, Ripa RS, Kjaer A, Hansen TW, Vilsboll T, Vestergaard H, Rossing P, Legido-Quigley C. Ceramides are decreased after liraglutide treatment in people with type 2 diabetes: a post hoc analysis of two randomized clinical trials. Lipids Health Dis. 2023 Sep 26;22(1):160. doi: 10.1186/s12944-023-01922-z.

  PMID: 37752566 DERIVED

• von Scholten BJ, Persson F, Rosenlund S, Hovind P, Faber J, Hansen TW, Rossing P. The effect of liraglutide on renal function: A randomized clinical trial. Diabetes Obes Metab. 2017 Feb;19(2):239-247. doi: 10.1111/dom.12808. Epub 2016 Nov 21.

  PMID: 27753201 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Peter Rossing, MD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: September 10, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

DK (1)