The effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-002696-41-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-16
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 446

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified