The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure

NCT02284230 | Withdrawn Phase 2 DMC

• 1 other identifier: U1111-1149-7801
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD). The primary objective is to determine the efficacy of the treatment on glucose tolerance evaluated during a 3h 75g-oral glucose tolerance test (OGTT). Secondary objectives include various clinical and biochemical cardiovascular and safety parameters. We hypothesise that treatment with liraglutide can improve glucose tolerance in prediabetic patients with ESRD by normalizing plasma glucose excursions during an OGTT and ameliorate other cardiovascular risk factors.

Conditions

Kidney Failure, Chronic; Prediabetic State

Outcome Measures

Primary Outcomes (1)

• Plasma glucose during oral glucose tolerance test at week 26

  Difference between the two treatment arms in plasma glucose concentrations during a 3h 75g-OGTT on the trial visit of week 26

  The trial visit of week 26

Secondary Outcomes (16)

• Hypoglycemic incidents

  From the randomisation to trial visit of week 26

• Fasting values of glucometabolic hormones

  The trial visit of week 26

• Insulin resistance

  The trial visit of week 26

• Beta cell function

  The trial visit of week 26

• Change in glycemic state

  The trial visit of week 26

Study Arms (2)

Liraglutide treatment

ACTIVE COMPARATOR

Subcutaneous, once daily injection of liraglutide, individually dosed up to 1.8 mg/day.

Drug: Liraglutide

Placebo treatment

PLACEBO COMPARATOR

Subcutaneous, once daily injection of placebo, individually dosed up to 1.8 mg/day.

Drug: Placebo

Interventions

Liraglutide DRUG

Also known as: Victoza

Liraglutide treatment

Placebo DRUG

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End-stage renal disease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis)
• Impaired glucose tolerance (2h plasma glucose ≥ 7,8 and \< 11.1 mmol/l following a 75g-OGTT) and/or impaired fasting glucose (fasting plasma glucose ≥ 6.1 and \< 7.0 mmol/l) evaluated at the screening visit

You may not qualify if:

• Diabetes mellitus type 1 or type 2 (diagnose according to WHO criteria)
• Chronic pancreatitis / previous acute pancreatitis
• Known or suspected hypersensitivity to trial product(s) or related products
• Treatment with oral glucocorticoids, calcineurin inhibitors or incretin-based therapy 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, which in the investigator's opinion could interfere with the results of the trial
• Clinical suspicion of cardiac disease currently investigated
• 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
• Body mass index (BMI) \<20 kg/m2 and/or \>50 kg/m2
• Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods\*
• 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
• Screening calcitonin ≥ 50 ng/l
• Subjects with personal or family history of medullary thyroid carcinoma or a personal history of multiple endocrine neoplasia type 2
• Lawfully detained, institutionalised and patients who are unable to give informed consent due to physical or mental conditions will not be included.

Sponsors & Collaborators

• Bo Feldt-Rasmussen: lead
• Novo Nordisk A/S: collaborator
• The GCP unit at Copenhagen University Hospital: collaborator

Study Sites (1)

Department of Nephrology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Prediabetic State

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; 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

• Bo Feldt-Rasmussen, Prof,MD,DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, DMSc

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

DK (1)