Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 October 2014 |
Main ID: |
EUCTR2012-000140-97-BG |
Date of registration:
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21/05/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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11/07/2012 |
Target sample size:
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429 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000140-97 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Bulgaria
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Canada
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Germany
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India
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Israel
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Macedonia, the former Yugoslav Republic of
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Turkey
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United States
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Contacts
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Vandtaarnsvej 114, VTB
DK-2860
Soeborg
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Vandtaarnsvej 114, VTB
DK-2860
Soeborg
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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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
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Intervention(s)
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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
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Primary Outcome(s)
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Primary end point(s): Change in glycosylated haemoglobin (HbA1c) from baseline (randomisation, Visit 2)
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Timepoint(s) of evaluation of this end point: After 26 weeks of treatment
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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.
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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.
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Secondary Outcome(s)
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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)
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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
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Secondary ID(s)
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2012-000140-97-DE
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NN9068-3951
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Source(s) of Monetary Support
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Novo Nordisk A/S
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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