Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2014-005375-91-HR
• Date of registration: 01/02/2016
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes
• Scientific title: Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes
• Date of first enrolment: 30/12/2015
• Target sample size: 1196
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005375-91
• 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: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Croatia, European Union, Finland, Germany, Greece, Hong Kong, India, Ireland, Latvia, Lithuania, Portugal, Slovakia, Spain, United Kingdom, 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.
- 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

Health Condition(s) or Problem(s) studied

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

Diabetes Mellitus, Type 2
MedDRA version: 18.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Intervention(s)

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-

Primary Outcome(s)

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.

Primary end point(s): Change in HbA1c

Timepoint(s) of evaluation of this end point: From baseline to week 40

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1-4. From baseline to week 40
5. After 40 weeks treatment

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

Secondary ID(s)

NN9535-4216

2014-005375-91-IE

Source(s) of Monetary Support

Novo Nordisk A/S