Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

324

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Sep 2016

Typical duration for phase_3 diabetes

Geographic Reach

8 countries

117 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

July 6, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

February 17, 2020

Completed

Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

July 6, 2016

Results QC Date

October 15, 2019

Last Update Submit

February 14, 2020

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Week 0, week 26

Secondary Outcomes (39)

Change in Body Weight (kg)
Week 0, week 26
Change in FPG
Week 0, week 26
Change in Body Weight (%)
Week 0, week 26
Change in BMI
Week 0, week 26
Change in Waist Circumference
Week 0, week 26
+34 more secondary outcomes

Study Arms (2)

Semaglutide

EXPERIMENTAL

Drug: semaglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

semaglutideDRUG

Oral administration once daily.

Semaglutide

placeboDRUG

Oral administration once daily.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:
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)

You may not qualify if:

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
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)

Contact the study team to confirm eligibility.