Phase 4
Completed N=368
The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02008682 ↗Enrolled (actual)
368
Serious AEs
2.5%
Results posted
Dec 2015
Primary outcomePrimary: Change From Baseline in Glycosylated Haemoglobin (HbA1c) — -1.666; -0.969 Percent (%) glycosylated haemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Haemoglobin (HbA1c) |
-1.666; -0.969 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose |
-2.347; -1.205 | — |
| SECONDARY Change From Baseline in 7-point Self-measured Plasma Glucose Profile |
-2.25; -1.36 | — |
| SECONDARY Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target) |
76.5; 52.6 | — |
| SECONDARY Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target) |
61.7; 26.3 | — |
| SECONDARY Number of Confirmed Hypoglycaemic Episodes |
2; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02008682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.