NCT01617434
Completed
Phase 3
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 451
- Locations
- 1
- Primary Endpoint
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
Overview
Brief Summary
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 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)
- •HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
- •Body mass index (BMI) 20-45 kg/m\^2 (both inclusive)
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 investigator's opinion could interfere with results of the trial
- •Known or suspected abuse of alcohol or narcotics
Arms & Interventions
Liraglutide
Experimental
Intervention: liraglutide (Drug)
Placebo
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
Time Frame: Week 0 to Week 26
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Secondary Outcomes
- Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)(At Week 26)
- Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26(Week 0 to Week 26)
- Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)(At Week 26)
- Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period(Week 0 to Week 26 + 7 days follow up)
- Number of Adverse Events (AEs) During The Randomised Treatment Period(Week 0 to Week 26 + 7 days follow up)
- Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26(Week 0 to Week 26)
- Change in Body Weight From Baseline to Week 26(Week 0 to Week 26)
- Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period(Week 0 to Week 26 + 7 days follow up)
Investigators
Study Sites (1)
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