Efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 19.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2015-005326-19-FI
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-03
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

1. 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.
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Diagnosed with type 2 diabetes mellitus = 90 days prior to day of screening.
4. HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
5. 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.
6. 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 = 1500 mg or maximum tolerated dose documented in the subject medical record), - Sulfonylurea (= 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 (= 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 259
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

1. 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.
2. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
3. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
4. History of pancreatitis (acute or chronic).
5. 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).
6. 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.
7. Subjects presently classified as being in New York Heart Association Class IV.
8. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
9. Subjects with alanine aminotransferase > 2.5 x upper normal limit.
10. Rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (> 2200 mg/24 hours or > 2200 mg/g).
11. Use of systemic immunosuppressive treatment within 90 days prior to screening.
12. 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 = 14 days.
13. Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.
14. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.
15. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified