liraglutide
DrugAdministered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.
NCT Number: NCT02008682
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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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Novo Nordisk Investigational Site, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.
Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.
Time frame: Week 0, week 26
Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.
Time frame: Week 0, week 26
Mean change from baseline in fasting plasma glucose (FPG) at Week 26.
Time frame: Week 0, week 26
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: After 26 weeks of treatment
Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26
Time frame: After 26 weeks of treatment
Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26
Time frame: Weeks 0-26
confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L
Novo Nordisk A/S
Industry
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™)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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