Health Condition 1: null- Diabetes Mellitus, Type 2 Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Liraglutide: Max. 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subjectâ??s stable pre-trial basal insulin analogue regimen plus/minus metformi
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: HbA1c (glycosylated haemoglobin A1c) 7.0â??10.0% (both inclusive) Body mass index (BMI) 20â??45 kg/m2 (both inclusive) 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 with or without stable metformin equal to or above 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)
Exclusion criteria
Exclusion criteria: Female of child-bearing potential who is pregnant, breast-feeding or intending 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 (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg) Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigatorâ??s opinion could interfere with results of the trial Known or suspected abuse of alcohol or narcotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (glycosylated haemoglobin A1c) from baselineTimepoint: Week 0, week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 7-point self-measured plasma glucose from baselineTimepoint: Week 0, week 26;Change in body weight from baselineTimepoint: Week 0, week 26;Change in fasting plasma glucose (FPG) from baseline.Timepoint: Week 0, week 26;Number of subjects achieving HbA1c below 7.0%Timepoint: After 26 weeks of treatment;Number of subjects achieving HbA1c below or equal to 6.5%Timepoint: After 26 weeks of treatment;Number of subjects with adverse eventsTimepoint: After 26 weeks of treatment;Number of subjects with minor hypoglycaemic episodesTimepoint: After 26 weeks of treatment;Number of subjects with severe hypoglycaemic episodesTimepoint: After 26 weeks of treatment | — |
Countries
Argentina, Canada, Finland, Germany, India, Mexico, Netherlands, Serbia, Slovenia, United States of America
Contacts
Public ContactMr Avik Kumar Gosh
Novo Nordisk India Private Ltd
Outcome results
None listed