Efecto de insulina detemir en combinación con liraglutida y metformina en comparación con liraglutida y metformina en sujetos con diabetes tipo 2. Ensayo de 26 semanas, aleatorizado, abierto, de grupos paralelos, multicéntrico, multinacional con una extensión de 26 semanas

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2007-005317-19-ES
• Date of registration: 20/01/2009
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Efecto de insulina detemir en combinación con liraglutida y metformina en comparación con liraglutida y metformina en sujetos con diabetes tipo 2. Ensayo de 26 semanas, aleatorizado, abierto, de grupos paralelos, multicéntrico, multinacional con una extensión de 26 semanas
• Scientific title: Efecto de insulina detemir en combinación con liraglutida y metformina en comparación con liraglutida y metformina en sujetos con diabetes tipo 2. Ensayo de 26 semanas, aleatorizado, abierto, de grupos paralelos, multicéntrico, multinacional con una extensión de 26 semanas
• Date of first enrolment: 21/04/2009
• Target sample size: 940
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005317-19
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject)
2. Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for ? 3 months prior to screening, at a stable dose of ? 1500 mg/day or metformin (? 1500 mg/day) and a sulfonylurea (less than or equal to ½ of the maximum approved dose according to local label), both at a stable dose for ? 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed, at the discretion of the Investigator.
3. HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
HbA1c 7.0-8.5% (both inclusive) for subjects on metformin with a sulfonylurea
4. Age 18-80 years, both inclusive (or as allowed according to local guidelines)
5. Able and willing to perform self-monitoring of plasma glucose according to the protocol, to keep a diabetes diary and willing to use pen-injector device and FlexPen® device if necessary
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)
2. Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
3. Impaired liver function, defined as alanine aminotransferase (ALAT) ? 2.5 times upper normal limit (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being the conclusive)
4. Impaired renal function defined as serum-creatinine ? 133 µmol/L (? 1.5 mg/dL) for males and ? 115 µmol/L (? 1.4 mg/dL) for females, or as allowed according to local contraindications for metformin or sulfonylurea use (one retest analysed at the central laboratory within a week permitted with the result of the last sample being the conclusive)
5. History of chronic pancreatitis or idiopathic acute pancreatitis
6. Known history of unstable angina, acute coronary event, other significant cardiac event (including history of arrhythmias or conduction delays on ECG), or cerebral stroke within the past 6 months.
7. Heart failure NYHA class IV (see appendix D)
8. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
9. Uncontrolled treated or untreated hypertension (systolic blood pressure ? 180 mmHg and/or diastolic blood pressure ? 110 mmHg)
10. Cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the Investigator?s opinion could interfere with the results of the trial
11. Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
12. Known or suspected allergy to trial product(s) or related products
13. Use of any drug (except for those stated in the inclusion criteria), which in the Investigator?s opinion could interfere with the glucose level (eg systemic corticosteroids)
14. Receipt of any other investigational drug within 3 months prior to screening into this trial
15. Any contraindications to metformin or insulin detemir according to the local label
16. Surgery scheduled for the trial duration period (excluding minor surgical procedures performed in local anaesthesia, as judged by the Investigator)
17. Previous participation in the run-in period of this trial.
18. Known or suspected abuse of alcohol or narcotics
19. Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) UK: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods. France: Adequate contraceptive measures are defined as oral hormonal method of contraception or intrauterine device. Germany: Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner.
20. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
21. Subjects with medical history of MEN2 or FMTC if total thyroidectomy has not been performed or cannot be ensured (i.e. posterior capsule of the thyroid gland not removed)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

diabetes tipo 2 Type 2 diabetes
MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Intervention(s)

Product Name: Liraglutide 1,2 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Liraglutide
CAS Number: 204656-20-2
Other descriptive name: NNC 90-1170
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.0-

Trade Name: Levemir
Product Name: Levemir
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin detemir
CAS Number: 169148-63-4
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Product Name: Liraglutide 1,8 mg
Product Code: A10B
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Liraglutide
CAS Number: 204656-20-2
Other descriptive name: NNC 90-1170
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.0-

Primary Outcome(s)

Primary end point(s): ? Change in HbA1c from baseline to week 26 (using last observation carried forward)

Main Objective: To assess and compare the efficacy (as assessed by HbA1c) of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in subjects with type 2 diabetes after 26 weeks of randomised treatment.

Secondary Objective: To assess and compare the efficacy (as assessed by HbA1c) of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin and with the possibility of intensified treatment with insulin detemir from week 26, in subjects with type 2 diabetes, after totally 52 weeks of randomised treatment.
To assess and compare the effects of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin on other descriptors of glycaemic control (FPG, 7-point self-monitored glucose profiles, proportion of subjects reaching target HbA1c), C-peptide, proinsulin to C-peptide ratio, body weight, waist and hip circumference including the waist to hip ratio, lipids and blood pressure after 26 and 52 weeks.

Secondary ID(s)

NN2211-1842

2007-005317-19-NL

Ethics review

Status: Approved
Approval date: 08/04/2009
Contact:

Results

• Results available: Yes
• Date Posted: 22/05/2014
• Date Completed: 01/11/2010
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-005317-19/results