Clinical Trial Details

NCT ID: NCT03086330
Date Last Changed: September 28, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using Semaglutide and Placebo for patients with Diabetes or Diabetes Mellitus, Type 2

Research Study Title

Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus. A 30-week Randomised, Double-blind, Placebo-controlled Trial

Purpose

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.

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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, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent

  • Diagnosed with type 2 diabetes mellitus

  • HbA1c of 7.0-10.0% (53-86 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 (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label

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)

  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

  • 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 prior to the day of screening is allowed

  • Subjects with alanine aminotransferase above 2.5 x upper normal limit

  • 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)

  • History of diabetic ketoacidosis

  • Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening

  • Subjects presently classified as being in New York Heart Association Class IV

  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening

  • Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening

  • Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation

  • Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed

Site Locations (60)

Country State City Zip Facility and Contact
United States Alabama Andalusia 36420 Novo Nordisk Investigational Site
United States Arizona Glendale 85308 Novo Nordisk Investigational Site
United States Arizona Phoenix 85037 Novo Nordisk Investigational Site
United States Arizona Tempe 85283 Novo Nordisk Investigational Site
United States Arkansas Little Rock 72205 Novo Nordisk Investigational Site
United States California La Jolla 92037 Novo Nordisk Investigational Site
United States California Lincoln 95648 Novo Nordisk Investigational Site
United States California Northridge 91325 Novo Nordisk Investigational Site
United States Florida Edgewater 32132 Novo Nordisk Investigational Site
United States Florida Maitland 32751-4422 Novo Nordisk Investigational Site
United States Georgia Lawrenceville 30046 Novo Nordisk Investigational Site
United States Kansas Hutchinson 67502-1131 Novo Nordisk Investigational Site
United States Kentucky Lexington 40503 Novo Nordisk Investigational Site
United States Maryland Baltimore 21204 Novo Nordisk Investigational Site
United States Michigan Troy 48098-6368 Novo Nordisk Investigational Site
United States Missouri Jefferson City 65109 Novo Nordisk Investigational Site
United States New York Albany 12206 Novo Nordisk Investigational Site
United States New York Smithtown 11787 Novo Nordisk Investigational Site
United States New York West Seneca 14224 Novo Nordisk Investigational Site
United States North Carolina Charlotte 28204 Novo Nordisk Investigational Site
United States North Carolina Charlotte 28226 Novo Nordisk Investigational Site
United States North Carolina Gastonia 28054 Novo Nordisk Investigational Site
United States North Carolina Kinston 28501 Novo Nordisk Investigational Site
United States North Carolina Morehead City 28557-4346 Novo Nordisk Investigational Site
United States Oklahoma Norman 73069 Novo Nordisk Investigational Site
United States Pennsylvania Beaver 15009 Novo Nordisk Investigational Site
United States Pennsylvania McMurray 15317 Novo Nordisk Investigational Site
United States Pennsylvania Pittsburgh 15243 Novo Nordisk Investigational Site
United States Texas Arlington 76012-4637 Novo Nordisk Investigational Site
United States Texas Austin 78745 Novo Nordisk Investigational Site
United States Texas Dallas 75208 Novo Nordisk Investigational Site
United States Texas Dallas 75231 Novo Nordisk Investigational Site
United States Texas Houston 77081 Novo Nordisk Investigational Site
United States Texas Irving 75061-2210 Novo Nordisk Investigational Site
United States Texas Pasadena 77504 Novo Nordisk Investigational Site
United States Texas Shavano Park 78231 Novo Nordisk Investigational Site
United States Texas Victoria 77901 Novo Nordisk Investigational Site
United States Washington Olympia 98502 Novo Nordisk Investigational Site
Austria St. Stefan 8511 Novo Nordisk Investigational Site
Austria Wien 1030 Novo Nordisk Investigational Site
Austria Wien 1060 Novo Nordisk Investigational Site
Austria Wien 1130 Novo Nordisk Investigational Site
Canada Alberta Edmonton T6H 2L4 Novo Nordisk Investigational Site
Canada Manitoba Winnipeg R3E 3P4 Novo Nordisk Investigational Site
Canada Ontario Brampton L6S 0C9 Novo Nordisk Investigational Site
Canada Ontario Brampton L6T 0G1 Novo Nordisk Investigational Site
Canada Ontario Etobicoke M9R 4E1 Novo Nordisk Investigational Site
Canada Ontario Smiths Falls K7A 4W8 Novo Nordisk Investigational Site
Canada Ontario Toronto M5T 3L9 Novo Nordisk Investigational Site
Canada Ontario Waterloo N2J 1C4 Novo Nordisk Investigational Site
Japan Nagakute-shi, Aichi 480-1195 Novo Nordisk Investigational Site
Japan Shinjuku-ku, Tokyo 160-0008 Novo Nordisk Investigational Site
Japan Yokohama-shi Kanagawa 232-0064 Novo Nordisk Investigational Site
Norway Hamar 2317 Novo Nordisk Investigational Site
Norway Namsos 7801 Novo Nordisk Investigational Site
Norway Olso 0953 Novo Nordisk Investigational Site
Norway Oslo 0176 Novo Nordisk Investigational Site
Norway Stavanger 4005 Novo Nordisk Investigational Site
Puerto Rico Ponce 00716 Novo Nordisk Investigational Site
Russian Federation Saint-Petersburg 191119 Novo Nordisk Investigational Site

Contact

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

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