DiabetesPhase 4NCT02008682

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

A Phase 4 study testing liraglutide and sitagliptin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: liraglutide and sitagliptin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 368 participants
Where: 25 sitesChina
Study dates: Dec 2013to Nov 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

China25 sites

Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100071
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100700
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100853
Novo Nordisk Investigational Site
Beijing, 101200
Novo Nordisk Investigational Site
Cangzhou, Hebei, 061000
Novo Nordisk Investigational Site
Changchun, Jilin, 130041
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, 404000
Novo Nordisk Investigational Site
Dalian, Liaoning, 116033
Novo Nordisk Investigational Site
Hengshui, Hebei, 053000
Novo Nordisk Investigational Site
Nanchang, Jiangxi, 330006
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210011
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210012
Novo Nordisk Investigational Site
Nanjing, Jiangsu, 210029
Novo Nordisk Investigational Site
Qingdao, Shandong, 266003
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200080
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200092
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200120
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200240
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 201199
Novo Nordisk Investigational Site
Shenyang, Liaoning, 110021
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, 050000
Novo Nordisk Investigational Site
Shijiazhuang, Hebei, 050051
Novo Nordisk Investigational Site
Suzhou, Jiangsu, 215004
Novo Nordisk Investigational Site
Wuxi, Jiangsu, 214023
Novo Nordisk Investigational Site
Zhenjiang, Jiangsu, 212001

Other trials in China

About this study

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™)

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: liraglutide, sitagliptin
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02008682
Study group	Role	What they receive
Liraglutide 1.8 mg + metformin	Experimental	2-week screening period, 26-week treatment duration, and a 1-week follow-up period Receives: Drug: liraglutide
Sitagliptin 100 mg + metformin	Active comparator	2-week screening period, 26-week treatment duration, and a 1-week follow-up period Receives: Drug: sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

Change From Baseline in Fasting Plasma Glucose
Mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Measured: Week 0, 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.
Measured: Week 0, week 26
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
Measured: After 26 weeks of treatment
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
Measured: After 26 weeks of treatment
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
Measured: Weeks 0-26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Nov 2014

First posted11 Dec 2013 (estimated)
Study startDec 2013
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 368 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02008682
Sponsor's protocol ID: NN2211-4075
Other IDs: U1111-1139-0016
Status last verified: Jan 2017
First submitted: 5 Dec 2013
Last updated: 9 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27060930

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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™)
ClinicalTrials.gov ID: NCT02008682
Acronym / sponsor ID: NN2211-4075
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 368 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 11 Dec 2013 (estimated)
Results: Posted 22 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Liraglutide 1.8 mg + metformin	Experimental	Drug: liraglutide2-week screening period, 26-week treatment duration, and a 1-week follow-up period
Sitagliptin 100 mg + metformin	Active comparator	Drug: sitagliptin2-week screening period, 26-week treatment duration, and a 1-week follow-up period

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutideAdministered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.	Drug	Liraglutide 1.8 mg + metformin
sitagliptinAdministered orally once daily as add-on to the subject's stable pre-trial metformin dose.	Drug	Sitagliptin 100 mg + metformin

Primary outcome

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

5 secondary outcomes

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

Results and safety

Results posted to the registry on 22 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide	184	157
Sitagliptin	184	170

Primary outcome: Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame: Week 0, week 26. Mean (Standard Deviation). Unit: Percent (%) glycosylated haemoglobin

Measure	Liraglutide n = 162	Sitagliptin n = 175
Value	-1.666 (0.9982)	-0.969 (0.9742)

Population analysed: Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn't have a corresponding post-baseline value.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Weeks 0-26. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide	3 of 183 (1.6%)	65 of 183 (35.5%)	Not reported
Sitagliptin	6 of 184 (3.3%)	14 of 184 (7.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27060930Zang 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

25 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing liraglutide and sitagliptin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02008682, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.