Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and safety of liraglutide compared to sitagliptin, both as add-on to metformin in Chinese subjects with type 2 diabetes inadequately controlled on metformin monotherapy. Eligible subjects will continue their metformin background treatment during the trial.

Trial Health

On Track

Trial Health Score

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

Enrollment

368

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Dec 2013

Shorter than P25 for phase_4 diabetes

Geographic Reach

1 country

25 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

11 months study duration

Study Start

First participant enrolled

December 1, 2013

Completed

4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 22, 2015

Completed

Last Updated

March 9, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

December 5, 2013

Results QC Date

November 18, 2015

Last Update Submit

January 26, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Week 0, week 26

Secondary Outcomes (5)

Change From Baseline in Fasting Plasma Glucose
Week 0, week 26
Change From Baseline in 7-point Self-measured Plasma Glucose Profile
Week 0, week 26
Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)
After 26 weeks of treatment
Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)
After 26 weeks of treatment
Number of Confirmed Hypoglycaemic Episodes
Weeks 0-26

Study Arms (2)

Liraglutide 1.8 mg + metformin

EXPERIMENTAL

2-week screening period, 26-week treatment duration, and a 1-week follow-up period

Drug: liraglutide

Sitagliptin 100 mg + metformin

ACTIVE COMPARATOR

2-week screening period, 26-week treatment duration, and a 1-week follow-up period

Drug: sitagliptin

Interventions

liraglutideDRUG

Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.

Liraglutide 1.8 mg + metformin

sitagliptinDRUG

Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.

Sitagliptin 100 mg + metformin

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female, age at least 18 years and below 80 years at the time of signing informed consent
Subjects diagnosed type 2 diabetes mellitus and treated with metformin monotherapy at a stable dose of at least 1500 mg daily or maximum tolerated dose above or equal to 1000 mg daily for at least 60 days prior to screening
HbA1c 7.0-10.0% (both inclusive)
Body mass index below or equal to 45.0 kg/m\^2

You may not qualify if:

History of chronic pancreatitis or idiopathic acute pancreatitis
Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
Screening calcitonin value above or equal to 50 ng/l
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Any contraindications to liraglutide, sitagliptin or metformin according to local labelling

Contact the study team to confirm eligibility.