Liraglutide to overweight patients with insulin treated type 2 diabetes

Addition of liraglutide to overweight patients with type 2 diabetes treated with multiple daily insulin injections (MDI) with inadequate glycaemic control

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001941-42-SE

Enrollment

120

Registered

2012-07-16

Start date

2012-11-13

Completion date

Unknown

Last updated

2020-06-02

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

Conditions

Diabetes Mellitus Type 2 MedDRA version: 14.1 Level: PT Classification code 10053247 Term: Insulin-requiring type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Victoza, solution for injection Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Liraglutide CAS Number: 204656-20-2 Concentration unit: mg/ml milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: • Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management) • Type 2 diabetes • Adult patients over 18 years of age and less than 75 years of age • HbA1c greater than 8.0% (NGSP standard=DCCT standard)=64 mmol/mol (IFCC standard) and less than 11.5% (102 mmol/mol) • Treated with MDI for at least the last 6 months • Treated with/without metformin as only diabetes therapy apart from insulin • Fasting C-peptide of 0.2 nmol/l or greater (ref. 0.25-0.75nmol/l) • BMI greater than 28 kg/m2 and less than 45 kg/m2 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 78 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42

Exclusion criteria

Exclusion criteria: Exclusion criteria: • Type 1 diabetes • Fasting glucose less than 7.0 mmol/l or greater than 15 mmol/l • Unstable cardiovascular disease, NYHA Class II or greater heart failure , new symptoms of cardiovascular disease) • Proliferative diabetic retinopathy or clinically significant macula oedema. Retinal photograph should not be older than 3 years. • Systemic glucocorticoid treatment during the last 3 months • Acute coronary syndrome, stroke, coronary artery intervention or myocardial infarction during the previous 6 months • Creatinine greater than 130 micromol/l • Liver transaminases greater than double of the normal reference interval • Treatment with other oral antidiabetic agents than metformin during the previous 3 months • Treatment with GLP-1 receptor agonists within 90 days of screening • Severe psychiatric disorder (untreated severe depression, schizophrenia, dementia or severe alcohol or drug abuse) • Frequent non-severe hypoglycaemia (greater than 2 times per week) or any severe hypoglycaemia during the previous month. • Hypoglycaemic unawareness • Current cancer or diagnosis of cancer in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer). • Personal history of non-familial thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN2) • Screening calcitonin values greater than 50 ng/l • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice; e.g. oral contraceptive pills and intrauterine device (IUD)). • Blood pressure greater than 160/100 mmHg • Need for continuous use of paracetamol. During the 3 periods of 7 days with CGM, paracetamol cannot be used. Alternative pain killers can be substituted if plausible because paracetamol is the only medication influencing CGM results. • History of chronic or acute pancreatitis • Inflammatory Bowel Disease

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to determine whether liraglutide, compared to placebo reduces the HbA1c level for type 2 diabetes patients with inadequate glycaemic control treated with multiple daily insulin injections.;Secondary Objective: Secondary objectives are comparison of the following variables between diabetic patients with liraglutide added and diabetic patients with placebo added: • Weight • Fasting glucose • Glucose variability • Postprandial glucose levels • Health-related quality of life • Targeted HbA1c • Total insulin dose • Blood pressure level • Hypoglycaemia • Blood lipid levels ;Primary end point(s): Primary endpoint will be change in HbA1c from baseline to week 24.;Timepoint(s) of evaluation of this end point: HbA1c will be measured at baseline, week 6, week 12, week 18 and week 24.	—

Measure

Time frame

Main Objective: The primary objective of this study is to determine whether liraglutide, compared to placebo reduces the HbA1c level for type 2 diabetes patients with inadequate glycaemic control treated with multiple daily insulin injections.;Secondary Objective: Secondary objectives are comparison of the following variables between diabetic patients with liraglutide added and diabetic patients with placebo added: • Weight • Fasting glucose • Glucose variability • Postprandial glucose levels • Health-related quality of life • Targeted HbA1c • Total insulin dose • Blood pressure level • Hypoglycaemia • Blood lipid levels ;Primary end point(s): Primary endpoint will be change in HbA1c from baseline to week 24.;Timepoint(s) of evaluation of this end point: HbA1c will be measured at baseline, week 6, week 12, week 18 and week 24.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints will be: • Change in weight from baseline to week 24 • Change in fasting glucose from baseline to week 24 • Change in the standard deviation of CGM from the run-in period to week 23-24 • Change in mean glucose levels on CGM from the run-in period to week 23-24 • Change in 1.5 hour postprandial glucose levels on capillary glucose measurements from the run-in period to week 23-24 • Change in the score of the DTSQs from baseline to week 24 • Score of the DTSQc at week 24 • Proportion of patients with HbA1c less than 8.0% (64 mmol/mol) at week 24 • Proportion of patients with HbA1c less than 7.5% (58 mmol/mol) at week 24 • Change in total insulin dose from baseline to week 24 • Proportion of patients with HbA1c less than 7.0% (53 mmol/mol) at week 24 • Change in blood pressure from baseline to week 24 • Frequency of non-severe documented symptomatic hypoglycaemia (plasma glucose [PG] less than 4.0 mmol/l) from baseline to week 24 • Frequency of asymptomatic non-severe hypoglycaemia (PG less than 4.0 mmol/l) from baseline to week 24 • Frequency of non-severe documented symptomatic hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24 • Frequency of asymptomatic non-severe hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24 • Frequency of severe hypoglycaemia from baseline to week 24 • Change in blood lipid levels from baseline to week 24 ;Timepoint(s) of evaluation of this end point: At baseline, 6, 12, 18 and 24 weeks, weight, fasting plasma glucose, HbA1c, total insulin dose, blood pressure, and hypoglycaemias will be recorded. At baseline, 12 and 24 weeks, fasting blood lipids At baseline and 24 weeks, DTSQs will be recorded. At run-in period, 12weeks ± 7 days, and 23-24 weeks, change in standard deviation of CGM, change in mean glucose levels on CGM will be recorded. Ar run-in period and 23-24 weeks capillary glucose levels will be recorded. At 24 weeks DTSQc will be taken.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints will be: • Change in weight from baseline to week 24 • Change in fasting glucose from baseline to week 24 • Change in the standard deviation of CGM from the run-in period to week 23-24 • Change in mean glucose levels on CGM from the run-in period to week 23-24 • Change in 1.5 hour postprandial glucose levels on capillary glucose measurements from the run-in period to week 23-24 • Change in the score of the DTSQs from baseline to week 24 • Score of the DTSQc at week 24 • Proportion of patients with HbA1c less than 8.0% (64 mmol/mol) at week 24 • Proportion of patients with HbA1c less than 7.5% (58 mmol/mol) at week 24 • Change in total insulin dose from baseline to week 24 • Proportion of patients with HbA1c less than 7.0% (53 mmol/mol) at week 24 • Change in blood pressure from baseline to week 24 • Frequency of non-severe documented symptomatic hypoglycaemia (plasma glucose [PG] less than 4.0 mmol/l) from baseline to week 24 • Frequency of asymptomatic non-severe hypoglycaemia (PG less than 4.0 mmol/l) from baseline to week 24 • Frequency of non-severe documented symptomatic hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24 • Frequency of asymptomatic non-severe hypoglycaemia (PG less than 3.0 mmol/l) from baseline to week 24 • Frequency of severe hypoglycaemia from baseline to week 24 • Change in blood lipid levels from baseline to week 24 ;Timepoint(s) of evaluation of this end point: At baseline, 6, 12, 18 and 24 weeks, weight, fasting plasma glucose, HbA1c, total insulin dose, blood pressure, and hypoglycaemias will be recorded. At baseline, 12 and 24 weeks, fasting blood lipids At baseline and 24 weeks, DTSQs will be recorded. At run-in period, 12weeks ± 7 days, and 23-24 weeks, change in standard deviation of CGM, change in mean glucose levels on CGM will be recorded. Ar run-in period and 23-24 weeks capillary glucose levels will be recorded. At 24 weeks DTSQc will be taken.

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Countries

Sweden

Contacts

Public ContactUddevalla Hospital, Medicinkliniken

Västra Götalandsregionen

+46738311742

Outcome results

None listed

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