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

NCT ID: NCT02008682

Last Updated: 2017-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide 1.8 mg + metformin

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

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

Sitagliptin 100 mg + metformin

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

Group Type ACTIVE_COMPARATOR

sitagliptin

Intervention Type DRUG

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

Interventions

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liraglutide

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

Intervention Type DRUG

sitagliptin

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

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Chongqing, Chongqing Municipality, China

Site Status

Novo Nordisk Investigational Site

Cangzhou, Hebei, China

Site Status

Novo Nordisk Investigational Site

Hengshui, Hebei, China

Site Status

Novo Nordisk Investigational Site

Shijiazhuang, Hebei, China

Site Status

Novo Nordisk Investigational Site

Shijiazhuang, Hebei, China

Site Status

Novo Nordisk Investigational Site

Nanjing, Jiangsu, China

Site Status

Novo Nordisk Investigational Site

Nanjing, Jiangsu, China

Site Status

Novo Nordisk Investigational Site

Nanjing, Jiangsu, China

Site Status

Novo Nordisk Investigational Site

Suzhou, Jiangsu, China

Site Status

Novo Nordisk Investigational Site

Wuxi, Jiangsu, China

Site Status

Novo Nordisk Investigational Site

Zhenjiang, Jiangsu, China

Site Status

Novo Nordisk Investigational Site

Nanchang, Jiangxi, China

Site Status

Novo Nordisk Investigational Site

Changchun, Jilin, China

Site Status

Novo Nordisk Investigational Site

Dalian, Liaoning, China

Site Status

Novo Nordisk Investigational Site

Shenyang, Liaoning, China

Site Status

Novo Nordisk Investigational Site

Qingdao, Shandong, China

Site Status

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, China

Site Status

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, China

Site Status

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, China

Site Status

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, China

Site Status

Novo Nordisk Investigational Site

Shanghai, Shanghai Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, , China

Site Status

Countries

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China

References

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Zang L, Liu Y, Geng J, Luo Y, Bian F, Lv X, Yang J, Liu J, Peng Y, Li Y, Sun Y, Bosch-Traberg H, Mu Y. Efficacy and safety of liraglutide versus sitagliptin, both in combination with metformin, in Chinese patients with type 2 diabetes: a 26-week, open-label, randomized, active comparator clinical trial. Diabetes Obes Metab. 2016 Aug;18(8):803-11. doi: 10.1111/dom.12674. Epub 2016 May 20.

Reference Type RESULT
PMID: 27060930 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1139-0016

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-4075

Identifier Type: -

Identifier Source: org_study_id

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