Diabetes Mellitus, Type 2 MedDRA version: 14.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day plus/minus stable metformin above or equal to 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator) - HbA1c 7.0–10.0% (both inclusive) - Body mass index (BMI) 20–45 kg/m^2 (both inclusive) - Age 18 - 80 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 321 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: - Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant - Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness - Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening - Impaired liver or renal function - Uncontrolled treated or untreated hypertension (SBP above or equal to 180 mmHg and/or DBP above or equal to 100 mmHg) - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator’s opinion could interfere with results of the trial - Known or suspected abuse of alcohol or narcotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority on glycaemic control of liraglutide versus liraglutide placebo after 26 weeks of treatment when added to pre-existing basal insulin analogue treatment (with or without concomitant metformin treatment) in subjects with type 2 diabetes. ;Secondary Objective: To compare the effect of adding liraglutide versus liraglutide placebo to pre-existing basal insulin analogue treatment plus/minus metformin on: - Descriptors of beta cell function - Cardiovascular risk factors - Safety ;Primary end point(s): Change in HbA1c ;Timepoint(s) of evaluation of this end point: From baseline to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in: 1. Fasting plasma glucose (FPG) 2. 7-point self-measured plasma glucose 3. Body weight Number of subjects achieving: 4. HbA1c below 7.0% (American Diabetes Association (ADA) target) 5. HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) Safety: 6. Number of adverse events (AEs) 7. Number of minor or severe hypoglycaemic episodes during the randomised treatment period;Timepoint(s) of evaluation of this end point: 1. - 3. From baseline to week 26 4. - 7. After 26 weeks of treatment | — |
Countries
Argentina, Canada, Finland, Germany, India, Mexico, Netherlands, Serbia, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed