Clinical Trial Details

NCT ID: NCT02827708
Date Last Changed: October 10, 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 Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

Purpose

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment.

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Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Novo Nordisk A/S
Duration
16 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 above or equal to 18 years at the time of signing informed consent

  • Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening

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

  • Moderate renal impairment defined as estimated glomerular filtration rate of 30-59 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula

  • Stable daily dose(s) within 90 days prior to the day of screening of any of the following treatment regimens:- 1-2 of the following oral anti-diabetic drugs: - Metformin equal or above 1500 mg or maximum tolerated dose documented in the subject medical record), - Sulfonylurea (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) - Basal insulin alone (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin) or - Metformin (equal or above 1500 mg or maximum tolerated dose documented in the subject medical record) in combination with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin)

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).For certain specific countries: Additional specific requirements apply

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

  • Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma

  • History of pancreatitis (acute or chronic)

  • History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

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

  • 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

  • Subjects with alanine aminotransferase above 2.5 x upper normal limit

  • Rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above 2200 mg/24 hours or above 2200 mg/g)

  • Use of systemic immunosuppressive treatment within 90 days prior to screening

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days

  • Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator

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

  • History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

Site Locations (5)

Country State City Zip Facility and Contact
United States California Bermuda Dunes 92203 Novo Nordisk Investigational Site
United States Maryland Baltimore 21287 Novo Nordisk Investigational Site
Russian Federation Chelyabinsk 454000 Novo Nordisk Investigational Site
Russian Federation Voronezh 394018 Novo Nordisk Investigational Site
Russian Federation Yaroslavl 150062 Novo Nordisk Investigational Site

Contact

Novo Nordisk

E-mail:

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