Brief Summary

This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in 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

706

participants targeted

Target at P75+ for phase_2 diabetes

Timeline

Completed

Started Sep 2015

Geographic Reach

10 countries

150 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

June 1, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

September 21, 2015

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2016

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed

Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

June 1, 2015

Results QC Date

December 21, 2017

Last Update Submit

July 30, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy.
Week 0, week 26

Secondary Outcomes (3)

Change in Fasting Plasma Glucose (FPG)
Week 0, Week 26
Body Weight Change
Week 0, Week 26
Change in Systolic and Diastolic Blood Pressure
Week 0, Week 26

Study Arms (13)

Semaglutide 0.05 mg/day

EXPERIMENTAL

Drug: semaglutide

Liraglutide 0.3 mg/day

ACTIVE COMPARATOR

Drug: liraglutide

Placebo 50 µL

PLACEBO COMPARATOR

Drug: placebo

Semaglutide 0.05/0.1 mg/day

EXPERIMENTAL

Drug: semaglutide

Liraglutide 0.3/0.6 mg/day

ACTIVE COMPARATOR

Drug: liraglutide

Placebo 50/100 µL

PLACEBO COMPARATOR

Drug: placebo

Semaglutide 0.05/0.1/0.2 mg/day

EXPERIMENTAL

Drug: semaglutide

Liraglutide 0.3/0.6/1.2 mg/day

ACTIVE COMPARATOR

Drug: liraglutide

Placebo 50/100/200 µL

PLACEBO COMPARATOR

Drug: placebo

Semaglutide 0.05/0.1/0.2/0.3 mg/day

EXPERIMENTAL

Drug: semaglutide

Liraglutide 0.3/0.6/1.2/1.8 mg/day

ACTIVE COMPARATOR

Drug: liraglutide

Placebo 50/100/200/300 µL

PLACEBO COMPARATOR

Drug: placebo

Semaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day

EXPERIMENTAL

Drug: semaglutide

Interventions

semaglutideDRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.

Semaglutide 0.05 mg/daySemaglutide 0.05/0.1 mg/daySemaglutide 0.05/0.1/0.2 mg/daySemaglutide 0.05/0.1/0.2/0.3 mg/daySemaglutide flexible escalation from 0.05 mg/day to 0.3 mg/day

liraglutideDRUG

Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.

Liraglutide 0.3 mg/dayLiraglutide 0.3/0.6 mg/dayLiraglutide 0.3/0.6/1.2 mg/dayLiraglutide 0.3/0.6/1.2/1.8 mg/day

placeboDRUG

Administered subcutaneously ( s.c., under the skin) once daily.

Placebo 50 µLPlacebo 50/100 µLPlacebo 50/100/200 µLPlacebo 50/100/200/300 µL

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female, age at least 18 years at the time of signing informed consent.
Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
BMI: 25.0 - 40.0 kg/m\^2 (both inclusive)

You may not qualify if:

Simultaneous participation in any other clinical trial of an investigational medicinal product
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
History of pancreatitis (acute or chronic)
Screening calcitonin above or equal to 50 ng/L
Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m\^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology)
Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
Currently planned coronary, carotid or peripheral artery revascularisation
Patients presently classified as being in New York Heart Association (NYHA) Class III or IV

Contact the study team to confirm eligibility.