The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2012-000140-97-BG
• Date of registration: 21/05/2012
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy
• Scientific title: The efficacy of insulin degludec/liraglutide as add-on therapy in controlling glycaemia in adults with type 2 diabetes inadequately controlled on sulphonylurea with or without metformin therapy - DUAL™ IV - SU Add-On
• Date of first enrolment: 11/07/2012
• Target sample size: 429
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000140-97
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Bulgaria, Canada, Germany, India, Israel, Macedonia, the former Yugoslav Republic of, 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:
- Subjects with Type 2 Diabetes Mellitus
- Male or female = 18 years of age
- HbA1c 7.0-9.0% (53-75 mmol/mol)(both inclusive)
- Subjects on stable daily dose of sulphonylurea (= half of the max approved dose according to local label) with or without metformin (= 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
- 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 321
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108

Exclusion criteria:
- Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combination with metformin) = 90 days prior to screening visit (Visit 1)
- Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
- Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
- Screening calcitonin = 50 ng/l
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
- Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator’s opinion
- Subjects with a clinical significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the Type 2 Diabetes Mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product
- History of chronic pancreatitis or idiopathic acute pancreatitis


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: 15.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Intervention(s)

Product Name: Insulin degludec liraglutide 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-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Change in glycosylated haemoglobin (HbA1c) from baseline (randomisation, Visit 2)

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

Main Objective: To confirm superiority of insulin degludec/liraglutide compared to insulin degludec/liraglutide placebo in controlling glycaemia as add-on treatment in insulin naïve subjects with Type 2 Diabetes Mellitus (T2DM) inadequately controlled on sulphonylurea (SU) with or without metformin therapy after 26 weeks of treatment.

Secondary Objective: To compare general efficacy and safety of the addition of insulin degludec/liraglutide and insulin degludec/liraglutide placebo in insulin naïve subjects with T2DM inadequately controlled on SU with or without metformin therapy compared to after 26 weeks of treatment.

Secondary Outcome(s)

Secondary end point(s): 1 - Responders achieving pre-defined target for HbA1c
o HbA1c < 7.0% (53 mmol/mol) at end of treatment
o HbA1c = 6.5% (48 mmol/mol) at end of treatment
2 - Change from baseline in fasting plasma glucose (FPG)
3 - Change from baseline in body weight
4 - Number of severe or minor hypoglycaemic episodes
5 - Number of adverse events (AEs)

Timepoint(s) of evaluation of this end point: 1 - After 26 weeks of treatment
o HbA1c < 7.0% (53 mmol/mol) at end of treatment
o HbA1c = 6.5% (48 mmol/mol) at end of treatment
2 - After 26 weeks of treatment
3 - After 26 weeks of treatment
4 - During 26 weeks of treatment
5 - During 26 weeks of treatment

Secondary ID(s)

2012-000140-97-DE

NN9068-3951

Source(s) of Monetary Support

Novo Nordisk A/S