The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2Health Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2012/10/003072
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 69
HbA1c (glycosylated haemoglobin A1c) 7.0â??10.0% (both inclusive)
Body mass index (BMI) 20â??45 kg/m2 (both inclusive)
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)
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 investigatorâ??s opinion could interfere with results of the trial
Known or suspected abuse of alcohol or narcotics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method