A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) in subjects with type 2 diabetes mellitus using two different titration algorithms

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2012-004625-25-HU
• Date of registration: 19/06/2014
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) in subjects with type 2 diabetes mellitus using two different titration algorithms
• Scientific title: A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) in subjects with type 2 diabetes mellitus using two different titration algorithms - DUAL™ VI - Easy Titration
• Date of first enrolment: 29/08/2014
• Target sample size: 416
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004625-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Treat-to-target If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Comparison of two different titration algorithms Number of treatment arms in the trial: 2

Countries of recruitment

Austria, Bulgaria, Canada, Czech Republic, European Union, Hungary, Russian Federation, Serbia, Slovakia, United States

Contacts

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

• Name: Global Clinical Registry (GCR,1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion criteria:
1. Type 2 diabetes mellitus
2. Male or female =18 years of age
3. HbA1c 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
4. Stable daily treatment with metformin (=1500 mg or max tolerated dose) ± pioglitazone (=30 mg) for at least 90 days prior to screening
5. Body Mass Index (BMI) =40 kg/m^2
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 278
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 138

Exclusion criteria:
1. Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
2. Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
3. Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
4. Impaired liver function, defined as alanine aminotransferase (ALAT) =2.5 times upper normal range (UNR)
5. Impaired renal function defined as serum-creatinine =133 µmol/L ( =1.5 mg/dL) for males and =125 µmol/L ( =1.4 mg/dL) for females, or as defined according to local contraindications for metformin
6. Screening calcitonin =50 ng/L
7. Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
9. History of pancreatitis (acute or chronic)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Diabetes Mellitus, Type 2
MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Intervention(s)

Product Name: Insulin degludec liraglutide V2 PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.6-

Primary Outcome(s)

Main Objective: To confirm the efficacy of insulin degludec/liraglutide (IDegLira), using a once weekly titration algorithm, in controlling glycaemia in insulin-naïve subjects with type 2 diabetes mellitus (T2DM), inadequately controlled on metformin alone or in combination with pioglitazone. This is done by comparing the difference in change from baseline HbA1c (glycosylated haemoglobin) after 32 weeks of treatment to a non-inferiority limit of 0.30 % for once weekly titration vs. twice weekly titration.

Timepoint(s) of evaluation of this end point: After 32 weeks of treatment

Secondary Objective: To compare efficacy in terms of other measures of glycaemic control and safety of IDegLira titrated using a once weekly vs. twice weekly algorithm after 32 weeks of treatment.

Primary end point(s): Change from baseline in HbA1c

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: After 32 weeks of treatment

Secondary end point(s): Responder (Yes/No) for:
– HbA1c <7.0%
– HbA1c =6.5%

Secondary ID(s)

NN9068-4056

Source(s) of Monetary Support

Novo Nordisk A/S