The effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes A 26-week double-blind placebo-controlled randomised multicentre, multinational parallel-group trial

Phase 3

Completed

Conditions: diabetes
diabetes mellitus
10018424

Registration Number: NL-OMON37485

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

-Diagnosed with type 2 diabetes for at least 180 days prior to screening
-HbA1c 7.0-10.0% (both inclusive)
-Body mass index (BMI) 20.0-45.0 kg/m2 (both inclusive)
-Age 18-80 years (both inclusive)

Exclusion Criteria

•Female 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 >=180 mmHg and/or DBP >=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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in HbA1c from baseline to week 26.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change from baseline to week 26 in:<br /><br>• Fasting plasma glucose (FPG).<br /><br>• 7-point self-measured plasma glucose<br /><br>• Body weight<br /><br>After 26 weeks treatment:<br /><br>Number of subjects achieving:<br /><br>• HbA1c < 7.0% (American Diabetes Association (ADA) target).<br /><br>• HbA1c <= 6.5% (American Association of Clinical Endocrinologists (AACE)<br /><br>target)<br /><br>Safety (after 26 weeks of treatment)<br /><br>Number of subjects with:<br /><br>• Adverse events (AEs)<br /><br>• Minor or severe hypoglycaemic episodes</p><br>