The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2
Diabetes

Interventions: Drug: placebo
Drug: liraglutide

Registration Number: NCT01617434

Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 451

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Liraglutide	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26	Week 0 to Week 26	The estimated mean change from baseline in HbA1c after 26 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)	At Week 26	Number of subjects achieving HbA1c below 7.0% (American Diabetes Association \[ADA\] target) after 26 weeks of treatment
Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26	Week 0 to Week 26	The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.
Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)	At Week 26	Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists \[AACE\] target) after 26 weeks of treatment.
Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period	Week 0 to Week 26 + 7 days follow up	A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL).
Number of Adverse Events (AEs) During The Randomised Treatment Period	Week 0 to Week 26 + 7 days follow up	An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26	Week 0 to Week 26	The estimated mean change from baseline in FPG after 26 weeks of treatment.
Change in Body Weight From Baseline to Week 26	Week 0 to Week 26	The estimated mean change in body weight after 26 weeks of treatment.
Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period	Week 0 to Week 26 + 7 days follow up	Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.