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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01617434

2011-002696-41 (EudraCT Number)

NN2211-3917

U1111-1121-9874 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 451 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

451 participants in 2 patient groups, including a placebo group

Liraglutide

Experimental group

Treatment:

Drug: liraglutide

Placebo

Placebo Comparator group

Treatment:

Drug: placebo