The effect of a new anti-diabetic drug (Liraglutide) on body weight in patients with type 2 diabetes mellitus

The effect of Liraglutide on insulin-associated weight gain in patients with type 2 diabetes - Liraglutide and weight gain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000411-12-NL

Enrollment

Registered

2011-11-02

Start date

2012-03-07

Completion date

Unknown

Last updated

2022-05-09

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

Conditions

patients with type 2 diabetes mellitus MedDRA version: 14.0 Level: PT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Victoza Product Name: Liraglutide Product Code: EMEA/H/C/001026 Pharmaceutical Form: Cutaneous liquid INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Other descriptive name: victo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with type 2 diabetes mellitus on short-term insulin therapy (= 12 months); all types of insulin allowed - Insulin-associated weight gain = 3.0 kg from the start of insulin therapy - Age 18-75 years - BMI = 25 kg/m2 - Stable glycaemic control mirrored by HbA1c = 6.5 and = 8.5 % 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Inability to provide informed consent - Type 1 diabetes mellitus, MODY diabetes, or LADA diabetes - Presence of any medical condition that might interfere with the current study protocol. - Inflammatory bowel disease (e.g. M. Crohn, ulcerative colitis) - Recurrent hypoglycaemic events - Diabetic gastroparesis - Heart failure (LVEF = 30%) - Use of TZDs (glitazones), DDP-IV (dipeptidylpeptidase-inhibitor) - Use of medication associated with impaired glucose metabolism including corticosteroids - Pregnancy or breast-feeding (contraception of at least 3 months before inclusion is required for fertile women) - Pre-existing thyroid disease - Liver disease (aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range) - Renal disease (creatinine > 130 µmol/l or MDRD-GFR <30 ml/min/1.73m2)

Design outcomes

Primary

Measure	Time frame
Main Objective: Our primary objective is to demonstrate that the addition of liraglutide 1.8 mg sc q.d. to patients on short-term insulin therapy (= 12 months) can reverse the (excessive) weight gain without deteriorating glycaemic control.;Secondary Objective: Our secondary objectives are to determine the effect of liraglutide on glycaemic control, number and severity of hypoglycaemic events, (decrease in) insulin dose, number of patients discontinuing insulin therapy, physical activity, cardiovascular risk markers and quality of life. ;Primary end point(s): Change in body weight after 6 months of Liraglutide treatment;Timepoint(s) of evaluation of this end point: Every 4 weeks outpatient contact, every 8 weeks A1c measurements and at the start and end Senswear body media monitoring	—

Measure

Time frame

Main Objective: Our primary objective is to demonstrate that the addition of liraglutide 1.8 mg sc q.d. to patients on short-term insulin therapy (= 12 months) can reverse the (excessive) weight gain without deteriorating glycaemic control.;Secondary Objective: Our secondary objectives are to determine the effect of liraglutide on glycaemic control, number and severity of hypoglycaemic events, (decrease in) insulin dose, number of patients discontinuing insulin therapy, physical activity, cardiovascular risk markers and quality of life. ;Primary end point(s): Change in body weight after 6 months of Liraglutide treatment;Timepoint(s) of evaluation of this end point: Every 4 weeks outpatient contact, every 8 weeks A1c measurements and at the start and end Senswear body media monitoring

—

Secondary

Measure	Time frame
Secondary end point(s): Insulin dose, hypoglycaemia and glucoses.;Timepoint(s) of evaluation of this end point: Every 4 weeks evaluation of insulin dose en glucoses.	—

Countries

Netherlands

Contacts

Public ContactTack CJJ

UMC St Radboud

c.tack@aig.umcn.nl+31243611111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026