This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
407
Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day)
100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)
Sitagliptin placebo tablets once-daily
Change in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).
Time frame: From baseline to week 26
Change in Body Weight
Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.
Time frame: From baseline to week 26
Change in Fasting Plasma Glucose
Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Time frame: From baseline to week 26
Change in Fasting Blood Lipids
Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein \[LDL\], very low density lipoprotein \[VLDL\], high density lipoprotein \[HDL\], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.
Time frame: From baseline to week 26
Change in Systolic Blood Pressure and Diastolic Blood Pressure
Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Time frame: From baseline to week 26
Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)
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Sitagliptin placebo tablets once-daily
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Phoenix, Arizona, United States
Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Escondido, California, United States
Novo Nordisk Investigational Site
Mission Viejo, California, United States
Novo Nordisk Investigational Site
Roseville, California, United States
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States
Novo Nordisk Investigational Site
Chiefland, Florida, United States
...and 96 more locations
Number of subjects who achieve HbA1c \<7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.
Time frame: After 26 weeks of treatment
Number of Treatment Emergent Adverse Events (TEAEs)
A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.
Time frame: During 26 weeks of treatment plus one week follow-up period.