The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: sitagliptin; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02008682

U1111-1139-0016 (Other Identifier)

NN2211-4075

Details and patient eligibility

About

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.

Enrollment: 368 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 60 days prior to screening. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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368 participants in 2 patient groups

Liraglutide 1.8 mg + metformin

Experimental group

Description:

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

Treatment:

Drug: liraglutide

Sitagliptin 100 mg + metformin

Active Comparator group

Description:

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

Treatment:

Drug: sitagliptin