Brief Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

397

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Dec 2014

Geographic Reach

6 countries

99 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

12 months study duration

First Submitted

Initial submission to the registry

November 28, 2014

Completed

3 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2015

Completed

2.2 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed

Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

November 28, 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 (Glycosylated Haemoglobin)
Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening \[\<= 8.0% or \> 8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.
Week 0, week 30

Secondary Outcomes (7)

Change in Body Weight
Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
week 0, week 30
Change in Insulin Dose
week 0, week 30
Change in Systolic and Diastolic Blood Pressure
week 0, week 30
Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)
week 0, week 30
+2 more secondary outcomes

Study Arms (4)

Semaglutide 0.5 mg/Week

EXPERIMENTAL

Drug: semaglutide

Semaglutide 1.0 mg/Week

EXPERIMENTAL

Drug: semaglutide

Semaglutide Placebo 0.5 mg/Week

PLACEBO COMPARATOR

Drug: placebo

Semaglutide Placebo 1.0 mg/Week

PLACEBO COMPARATOR

Drug: placebo

Interventions

semaglutideDRUG

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Semaglutide 0.5 mg/WeekSemaglutide 1.0 mg/Week

placeboDRUG

Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.

Semaglutide Placebo 0.5 mg/WeekSemaglutide Placebo 1.0 mg/Week

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.