The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/30/2013 |
Start Date: | September 2012 |
End Date: | September 2013 |
Contact: | Novo Nordisk |
Email: | clinicaltrials@novonordisk.com |
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.
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
We found this trial at
19
sites
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