EUCTR2011-002696-41-NLActive, not recruitingNot Applicable
The effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 446
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 plus/minus stable metformin above or equal to 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 7.0–10.0% (both inclusive)
- •- Body mass index (BMI) 20–45 kg/m^2 (both inclusive)
- •- Age 18 - 80 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 321
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
Exclusion Criteria
- •- Female of child-bearing potential who is pregnant, breast-feeding or intend 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 (SBP above or equal to 180 mmHg and/or DBP above or equal to 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
Investigators
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