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: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-002696-41-NL

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm superiority on glycaemic control of liraglutide versus liraglutide placebo after 26 weeks of treatment when added to pre-existing basal insulin analogue treatment (with or without concomitant metformin treatment) in subjects with type 2 diabetes.<br>;Secondary Objective: To compare the effect of adding liraglutide versus liraglutide placebo to pre-existing basal insulin analogue treatment plus/minus metformin on:<br>- Descriptors of beta cell function<br>- Cardiovascular risk factors<br>- Safety<br>;Primary end point(s): Change in HbA1c ;Timepoint(s) of evaluation of this end point: From baseline to week 26

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in:<br>1. Fasting plasma glucose (FPG)<br>2. 7-point self-measured plasma glucose<br>3. Body weight<br>Number of subjects achieving:<br>4. HbA1c below 7.0% (American Diabetes Association (ADA) target)<br>5. HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target)<br>Number of subjects with:<br>6. Adverse events (AEs)<br>7. Minor or severe hypoglycaemic episodes;Timepoint(s) of evaluation of this end point: 1. - 3. From baseline to week 26 <br>4. - 7. After 26 weeks of treatment<br>

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