Efficacy of blood sugar control with Victoza® (liraglutide) vs. oral antidiabetic drugs as add-on to metformin treatment in subjects with type 2 diabetes inadequately controlled on metformin treatment alone

• Register: EUCTR
• Last refreshed on: 16 December 2019
• Main ID: EUCTR2015-002417-29-LV
• Date of registration: 11/11/2015
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Efficacy of blood sugar control with Victoza® (liraglutide) vs. oral antidiabetic drugs as add-on to metformin treatment in subjects with type 2 diabetes inadequately controlled on metformin treatment alone
• Scientific title: Efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin vs. OADs as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes inadequately controlled with metformin monotherapy and treated in a primary care setting. A 104-week randomised, phase 4, two-arm, open-label, active-controlled, multicentre, multinational, parallel-group trial. - LIRA-PRIME
• Date of first enrolment: 08/01/2016
• Target sample size: 1994
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002417-29
• 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): no Therapeutic use (Phase IV): yes

Countries of recruitment

Canada, European Union, India, Latvia, Lebanon, Russian Federation, Serbia, 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:
1. Male or female = 18 years of age at the time of signing informed consent.
2. Subjects diagnosed (clinically) with type 2 diabetes = 90 days prior to the screening visit.
3. Stable daily dose of metformin as monotherapy = 1500 mg or maximum tolerated dose within 60 days prior to the screening visit.
4. HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit.
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 1694
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion criteria:
1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
2. Receipt of any investigational medicinal product within 30 days before the screening visit.
3. Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (=7 days in total) with insulin in connection with intercurrent illness.
4. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.



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)

Trade Name: Victoza
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sitagliptin
Other descriptive name: SITAGLIPTIN

Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: linagliptin
CAS Number: 668270-12-0
Other descriptive name: LINAGLIPTIN

Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: saxagliptin
Other descriptive name: SAXAGLIPTIN HYDROCHLORIDE

Pharmaceutical Form:
INN or Proposed INN: VILDAGLIPTIN
CAS Number: 274901-16-5

Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: dapagliflozin
CAS Number: 461432-26-8
Other descriptive name: DAPAGLIFLOZIN

Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: empagliflozin
CAS Number: 864070-44-0
Other descriptive name: EMPAGLIFLOZIN

Pharmaceutical Form: Tablet
INN or Proposed INN: GLICLAZIDE
CAS Number: 21187-98-4

Pharmaceutical Form: Tablet
INN or Proposed INN: GLIMEPIRIDE
CAS Number: 93479-97-1

Pharmaceutical Form: Tablet
INN or Proposed INN: PIOGLITAZONE
CAS Number: 111025-46-8

Primary Outcome(s)

Main Objective: To compare the efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin vs. oral antidiabetic drugs (OADs) as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes (T2D) treated in primary care, inadequately controlled with metformin monotherapy

Primary end point(s): Time to inadequate glycaemic control defined as HbA1c > 7.0% (53 mmol/mol) at two scheduled consecutive visits

Secondary Objective: To compare efficacy and safety of Victoza® as add-on to metformin vs. OADs as add-on to metformin after up to 104 weeks of treatment in subjects with type 2 diabetes (T2D) treated in primary care, inadequately controlled with metformin monotherapy

Timepoint(s) of evaluation of this end point: After the first 26 weeks of treatment and up to 104 weeks

Secondary Outcome(s)

Secondary end point(s): Number of subjects who achieve (Yes/No):
1. HbA1c = 6.5% (48 mmol/mol)
2. HbA1c = 7.0% (53 mmol/mol) without weight gain

Change from baseline in:
3. Fasting plasma glucose (FPG)
4. Body weight

Timepoint(s) of evaluation of this end point: For all secondary endpoints:
At 104 weeks or at premature treatment discontinuation

Secondary ID(s)

NN2211-4232

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date:
Contact: