Liraglutide with or without NEAT in type 2 diabetes mellitus; Effects on HbA1c, weight, blood pressure, quality of life and health care costs

Liraglutide with or without NEAT in type 2 diabetes mellitus; Effects on HbA1c, weight, blood pressure, quality of life and health care costs - GLP-1 and NEAT in RHZ

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39218

Enrollment

450

Registered

2012-10-25

Start date

2013-01-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

Arm A.: once daily subcutaneously liraglutide 1.8mg added to standard anti-diabetic care for 6 months Arm B.: once daily subcutaneously liraglutide 1.8mg added to standard anti-diabetic care and an

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained before any study-related activities 2. Men or women with type 2 diabetes mellitus 3. Insufficiënt glycaemic control during maximum (tolerable) dose monotherapy with metformin or a sulfonylurea derivate or during combination therapy with metformin and a sulfonylurea derivate or a thiazolinedione. 4. HbA1c >= 7.0% at screening 5. BMI >= 25.0 kg/m2 at screening 6. Age between 40-75 years

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus 2. HbA1c >= 10% at screening 3. Use of GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any DDP-4 inhibitor within 3 months prior to screening 4. Use of insulin within 3 months prior to screening 5. An acute coronary or cerebrovascular event in the previous 3 months at screening 6. Chronic heart failure NYHA class IV at screening 7. Estimated glomerular filtration rate (eGFR) as per Modification of Diet in Renal Disease (MDRD)

Design outcomes

Primary

Measure	Time frame
Percent change in: - HbA1c - Weight	—

Secondary

Measure	Time frame
Change in: - Blood pressure - Quality of life as measured using SF-36 and EQ-5D questionnaire - NEAT as measured using an activPAL* accelerometer - Cost-effectiveness analysis	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)