Brief Summary

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

1,089

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Aug 2014

Geographic Reach

14 countries

226 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

1.1 years study duration

First Submitted

Initial submission to the registry

April 24, 2014

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed

3 months until next milestone

Study Start

First participant enrolled

August 4, 2014

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2015

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

March 8, 2018

Completed

Last Updated

June 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

April 24, 2014

Results QC Date

December 14, 2017

Last Update Submit

May 28, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c From Baseline
Change in HbA1c from baseline to week 30.
Week 0, week 30

Secondary Outcomes (7)

Change in Body Weight From Baseline
Week 0, week 30
Change in Fasting Plasma Glucose From Baseline
Week 0, week 30
Change in Diastolic Blood Pressure.
Week 0, week 30
Change in Systolic Blood Pressure.
Week 0, week 30
Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™
Week 0, week 30
+2 more secondary outcomes

Study Arms (3)

Semaglutide 0.5 mg/week

EXPERIMENTAL

Drug: semaglutide

Semaglutide 1.0 mg/week

EXPERIMENTAL

Drug: semaglutide

Insulin glargine

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

semaglutideDRUG

Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.

Semaglutide 0.5 mg/weekSemaglutide 1.0 mg/week

insulin glargineDRUG

Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.

Insulin glargine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female, 18 years or older at the time of signing informed consent
Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

You may not qualify if:

Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
History of chronic or idiopathic acute pancreatitis
Screening calcitonin value greater than or equal to 50 ng/L
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
Acute coronary or cerebrovascular event within 90 days before randomisation
Heart failure, New York Heart Association Class IV
Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures

Contact the study team to confirm eligibility.