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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8 January 2018 |
Main ID: |
EUCTR2014-005375-91-DE |
Date of registration:
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14/09/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes
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Scientific title:
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Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes |
Date of first enrolment:
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19/11/2015 |
Target sample size:
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1196 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005375-91 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Canada
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Croatia
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European Union
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Finland
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Germany
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Greece
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Hong Kong
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India
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Ireland
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Latvia
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Lithuania
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Portugal
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Slovakia
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Spain
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United Kingdom
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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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Novo Allé
2880
Bagsværd
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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Novo Allé
2880
Bagsværd
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: - Male or female, age = 18 years at the time of signing informed consent.
- HbA1c 7.0 – 10.5% (53 – 91 mmol/mol) (both inclusive)
- Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening 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 957 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 239
Exclusion criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- Any condition, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of =14 days
- History of pancreatitis (acute or chronic)
- Screening calcitonin =50 ng/L
- Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
- Renal impairment defined as eGFR < 60 mL/min/1.73 m^2 as per CKD-EPI
- Subjects presently classified as being in New York Heart Association Class IV
- Planned coronary, carotid or peripheral artery revascularisation on the day of screening
- Proliferative retinopathy or maculopathy requiring acute treatment
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2 MedDRA version: 19.0
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
System Organ Class: 100000004861
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Intervention(s)
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Product Name: Semaglutide B 1.34mg/ml PDS290 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: Semaglutide CAS Number: 910463-68-2 Other descriptive name: SEMAGLUTIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.34-
Trade Name: Trulicity Pharmaceutical Form: Solution for injection INN or Proposed INN: dulaglutide Other descriptive name: dulaglutide Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.5-
Trade Name: Trulicity Pharmaceutical Form: Solution for injection INN or Proposed INN: dulaglutide Other descriptive name: dulaglutide Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 3-
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Primary Outcome(s)
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Secondary Objective: To compare the effect of once-weekly dosing of two dose levels of subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) in subjects with type 2 diabetes on a background treatment with metformin with regards to: - Body weight control - Blood pressure - Patient reported outcomes - Safety and tolerability
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Main Objective: To compare the effect of once-weekly dosing of two dose levels of subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) on glycaemic control in subjects with type 2 diabetes on a background treatment with metformin.
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Primary end point(s): Change in HbA1c
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Timepoint(s) of evaluation of this end point: From baseline to week 40
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Secondary Outcome(s)
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Secondary end point(s): Change in
1. Body weight (kg)
2. Fasting plasma glucose
3. Systolic and diastolic blood pressure
4. Overall scores for patient reported outcomes: Diabetes Treatment Satisfaction Questionnaire
5. Subjects who achieve (yes/no) HbA1c =6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target
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Timepoint(s) of evaluation of this end point: 1-4. From baseline to week 40
5. After 40 weeks treatment
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Secondary ID(s)
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NN9535-4216
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2014-005375-91-IE
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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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