Clinical Trial Details

NCT ID: NCT02964247
Date Last Changed: October 13, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating liraglutide and placebo for the treatment of Diabetes or Diabetes Mellitus, Type 2

Research Study Title

LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors

Purpose

The trial is conducted in Asia, Europe, North America and South America. The aim of the study is to compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor with or without metformin on glycaemic control in subjects with type 2 diabetes mellitus.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Novo Nordisk A/S
Duration
15 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

  • Male or female, age 18 years or older at the time of signing informed consent.

  • Diagnosed with type 2 diabetes mellitus.

  • HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).

  • Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (1500 mg or more, or maximum tolerated dose) for at least 90 days prior to the day of screening. All medications in compliance with current local label.

  • Body mass index of 20 kg/m^2 or above.

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).

  • History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.

  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 60 mL/min/1.73m^2 as defined by Kidney Disease Improving Global Outcomes (KDIGO) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening.

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days during the 90 days prior to screening is allowed.

  • Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative.

  • History or presence of pancreatitis (acute or chronic).

  • Impaired liver function, defined as ALT 2.5 or more times upper normal limit at screening.

  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV.

Site Locations (23)

Country State City Zip Facility and Contact
United States Florida Miami 33165 Novo Nordisk Investigational Site
United States Florida Tampa 33603 Novo Nordisk Investigational Site
United States Georgia Roswell 30076 Novo Nordisk Investigational Site
United States Nevada Henderson 89052-2649 Novo Nordisk Investigational Site
Brazil Parana Curitiba 80030-110 Novo Nordisk Investigational Site
Brazil Rio Grande do Sul Porto Alegre 90035-170 Novo Nordisk Investigational Site
Brazil Sao Paulo São Paulo 01228-000 Novo Nordisk Investigational Site
India Andhra Pradesh Hyderabad 500003 Novo Nordisk Investigational Site
India Karnataka Bangalore 560 017 Novo Nordisk Investigational Site
India Madhya Pradesh Indore 452010 Novo Nordisk Investigational Site
India Maharashtra Pune 411004 Novo Nordisk Investigational Site
India Tamil Nadu Coimbatore 641009 Novo Nordisk Investigational Site
India West Bengal Kolkata 700080 Novo Nordisk Investigational Site
India New Delhi 110001 Novo Nordisk Investigational Site
Israel Haifa 35152 Novo Nordisk Investigational Site
Israel Kfar Saba 44281 Novo Nordisk Investigational Site
Israel Tel Hashomer 52621 Novo Nordisk Investigational Site
Israel Tel-Aviv 62038 Novo Nordisk Investigational Site
Russian Federation Saint-Petersburg 190068 Novo Nordisk Investigational Site
Russian Federation Saint-Petersburg 199226 Novo Nordisk Investigational Site
Russian Federation St. Petersburg 194354 Novo Nordisk Investigational Site
United Arab Emirates Al Ain 1006 Novo Nordisk Investigational Site
United Arab Emirates Umm Al Quwain 24 Novo Nordisk Investigational Site

Contact

Novo Nordisk
(+1) 866-867-7178
E-mail:

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