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

Phase 1

• Conditions: patients with type 2 diabetes mellitus; Therapeutic area: Diseases [C] - Hormonal diseases [C19]; MedDRA version: 14.0Level: PTClassification code 10053247Term: Insulin-requiring type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2011-000411-12-NL
• Lead Sponsor: MC St Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-02
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.