The Effects of Physical Training and GLP-1 Receptor Agonist Liraglutide Treatment in Patients With Type 2 Diabetes

Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455441

Enrollment

Registered

2011-10-20

Start date

2011-10-31

Completion date

2014-06-30

Last updated

2015-05-29

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

Conditions

Type 2 Diabetes

Keywords

GLP-1, Training, Exercise, Type 2 Diabetes

Brief summary

The objective of this study is to investigate the effects of physical training in patients with type 2 diabetes during treatment with the GLP-1 receptor agonist liraglutide (Victoza®) in a 16-weeks double-blinded, randomized placebo-controlled clinical trial. Hypothesis: Physical training leads to better metabolic control in type 2 diabetic patients when training is combined with liraglutide (Victoza®) treatment.

Interventions

OTHERTraining and liraglutide

OTHERTraining and placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Informed oral and written consent * Diagnosed with type 2 diabetes according to the criteria of the WHO * HbA1C: 7-11% (doing treatment with diet and/or metformin) * Age \>18 years * BMI \>25 kg/m2 \<40 kg/m2 * Negative islet cell antibodies (ICA) and glutamate decarboxylase 65 (GAD- 65) autoantibodies

Exclusion criteria

* Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures. * Subjects treated with sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, insulin or glitazones * Ongoing abuse of alcohol or narcotics * Impaired hepatic function (liver transaminases \>2 times upper normal limit) * Impaired renal function (se-creatinine \>150μM and/or albuminuria) * Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months * Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg) * Anaemia * Any condition that the investigators feels would interfere with trial participation * Receiving any investigational drug within the last 3 months

Design outcomes

Primary

Measure	Time frame	Description
HbA1c	16 weeks	Change in HbA1c from baseline to 16 weeks. Glycated haemoglobin (HbA1c) is a form of haemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time (12 weeks).

Secondary

Measure	Time frame	Description
Body weight	16 weeks	Changes in body weight from baseline to 16 weeks evaluated by a full body DEXA scan
Blood pressure	16 weeks	Changes in blood pressure from baseline to 16 weeks
Maximal oxygen uptake (VO2peak)	16 weeks	Changes in VO2peak from baseline to 16 weeks
Meal test	16 weeks	The changes in the postprandial response of incretin hormones, insulin and glucose, glucagon and the microvascular blood flow will be evaluated. Changes in blood leves of triglycerides and cholesterol.
Myocardial echocardiography	16 weeks	—
Glycaemic control	16 weeks	Changes in overall glycaemic control parameters, insulin sensitivity and beta cell function evaluated by The Homeostasis Model Assessment (HOMA) and incretin hormones response

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026