DUAL™VII - Insulin degludec/liraglutide (IDegLira) vs. basal-bolus therapy

• Register: EUCTR
• Last refreshed on: 12 December 2016
• Main ID: EUCTR2014-003621-18-GR
• Date of registration: 05/05/2015
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: DUAL™VII - Insulin degludec/liraglutide (IDegLira) vs. basal-bolus therapy
• Scientific title: DUAL™VII - Insulin degludec/liraglutide (IDegLira) vs. basal-bolus therapy: A clinical trial comparing efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in subjects with type 2 diabetes mellitus - DUAL™VII
• Date of first enrolment: 13/05/2015
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003621-18
• 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: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Czech Republic, European Union, France, Greece, Hungary, Israel, Mexico, Russian Federation, Slovakia, Spain, Turkey, 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:
- Male or female, age =18 years at the time of signing informed consent
- Type 2 diabetes subjects (diagnosed clinically) = 6 months prior to screening
- HbA1c 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
- Current treatment with IGlar for at least 90 calendar days prior to screening
- Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of ± 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
- Stable daily dose of metformin (=1500 mg or max. tolerated dose) for at least 90 calendar days prior to screening
- 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 375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion criteria:
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
- Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
- Impaired liver function, defined as alanine aminotransferase (ALT) =2.5 times upper limit of normal
- Renal impairment eGFR <60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
- Screening calcitonin =50 ng/L
- History of pancreatitis (acute or chronic)
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2



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: 18.0 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-

Trade Name: NovoRapid
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Lantus
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Main Objective: To confirm the efficacy of insulin degludec/liraglutide (IDegLira) in terms of glycaemic control in subjects with type 2 diabetes mellitus on previous treatment with insulin glargine (IGlar) and metformin. This is done by comparing the difference in change in HbA1c from baseline after 26 weeks of treatment to a non-inferiority limit of 0.30% for once daily IDegLira versus basal-bolus therapy with once daily IGlar plus prandial insulin aspart (IAsp), both arms in combination with metformin.

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

Timepoint(s) of evaluation of this end point: After 26 weeks of treatment

Secondary Objective: 1. To confirm superiority of IDegLira versus basal-bolus therapy in terms of:
- number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment
- change from baseline in body weight after 26 weeks of treatment
2. To compare general efficacy and safety of IDegLira versus basal-bolus therapy after 26 weeks of treatment.

Secondary Outcome(s)

Secondary end point(s): 1. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
2. Change from baseline in body weight
3. Responder for HbA1c (yes/no):
- HbA1c < 7.0%
- HbA1c = 6.5%

Timepoint(s) of evaluation of this end point: 1. During 26 weeks of treatment
2. After 26 weeks of treatment
3. After 26 weeks of treatment

Secondary ID(s)

2014-003621-18-HU

NN9068-4185

Source(s) of Monetary Support

Novo Nordisk A/S