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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT01617434

Run by

Novo Nordisk A/S

People needed

451

Starts

2012-09-01

Expected to finish

2013-10-01

Last updated by the study team

2017-03-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Anaheim, California, United States
• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — San Mateo, California, United States
• Novo Nordisk Investigational Site — San Ramon, California, United States
• Novo Nordisk Investigational Site — Tustin, California, United States
• Novo Nordisk Investigational Site — Ventura, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Kissimmee, Florida, United States
• Novo Nordisk Investigational Site — Gurnee, Illinois, United States
• Novo Nordisk Investigational Site — Greenfield, Indiana, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Metairie, Louisiana, United States
• Novo Nordisk Investigational Site — Rockville, Maryland, United States
• Novo Nordisk Investigational Site — Methuen, Massachusetts, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — Newington, New Hampshire, United States
• Novo Nordisk Investigational Site — Greensboro, North Carolina, United States
• Novo Nordisk Investigational Site — McMurray, Pennsylvania, United States
• Novo Nordisk Investigational Site — Spartanburg, South Carolina, United States
• Novo Nordisk Investigational Site — Kingsport, Tennessee, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — San Antonio, Texas, United States
• Novo Nordisk Investigational Site — San Antonio, Texas, United States
• Novo Nordisk Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.