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

Diabetes Mellitus, Type 2 Clinical Trial

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™)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008682
• Other study ID #: NN2211-4075
• Secondary ID: U1111-1139-0016
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2013
• Last updated: January 11, 2016
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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. Eligible subjects will continue their metformin background treatment during the trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.	Week 0, week 26	No
Secondary	Change From Baseline in Fasting Plasma Glucose	Mean change from baseline in fasting plasma glucose (FPG) at Week 26.	Week 0, week 26	No
Secondary	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.	Week 0, week 26	No
Secondary	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	After 26 weeks of treatment	No
Secondary	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	After 26 weeks of treatment	No
Secondary	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	Weeks 0-26	No

External Links

•   Clinical Trials at Novo Nordisk