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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
liraglutide
sitagliptin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liraglutide 1.8 mg + metformin

Sitagliptin 100 mg + metformin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose
Mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Change From Baseline in 7-point Self-measured Plasma Glucose Profile
Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time.
Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)
Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26
Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)
Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26
Number of Confirmed Hypoglycaemic Episodes
confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L

Full Information

First Posted
December 5, 2013
Last Updated
January 26, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02008682
Brief Title
The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Official Title
The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes.(LIRA-DPP-4 CHINA™)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide 1.8 mg + metformin
Arm Type
Experimental
Arm Description
2-week screening period, 26-week treatment duration, and a 1-week follow-up period
Arm Title
Sitagliptin 100 mg + metformin
Arm Type
Active Comparator
Arm Description
2-week screening period, 26-week treatment duration, and a 1-week follow-up period
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Haemoglobin (HbA1c)
Description
Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Time Frame
Week 0, week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose
Description
Mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Time Frame
Week 0, week 26
Title
Change From Baseline in 7-point Self-measured Plasma Glucose Profile
Description
Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time.
Time Frame
Week 0, week 26
Title
Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)
Description
Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26
Time Frame
After 26 weeks of treatment
Title
Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)
Description
Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26
Time Frame
After 26 weeks of treatment
Title
Number of Confirmed Hypoglycaemic Episodes
Description
confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L
Time Frame
Weeks 0-26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Novo Nordisk Investigational Site
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210012
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116033
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110021
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201199
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
ZIP/Postal Code
101200
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27060930
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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