Clinical trial NCT01465152: Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes
Official title: Multicentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-04
Enrollment: 182
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes
* Treated by diet for at least 3 months
* Never treated with hypoglycaemic drugs
* HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%

Exclusion Criteria:

* Very symptomatic diabetes
* Advanced vascular complications
* Manifest renal failure
* Manifest hepatic disease
* Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods

Primary outcomes:
measure: Change of % HbA1c (glycosylated haemoglobin) in blood
Secondary outcomes:
measure: Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres
measure: Incidence of clinical and/or biochemistry hypoglycaemia episodes
measure: Incidence of adverse events
measure: Presence of laboratory abnormalities in routine blood analyses
measure: Change of the blood pressure and/or heart rate
measure: Treatment compliance
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Novo Nordisk Investigational Site
city: Benamargosa
country: Spain
facility: Novo Nordisk Investigational Site
city: Burlada
country: Spain
facility: Novo Nordisk Investigational Site
city: Camas
country: Spain
facility: Novo Nordisk Investigational Site
city: Fuenlabrada
country: Spain
facility: Novo Nordisk Investigational Site
city: Gijón
country: Spain
facility: Novo Nordisk Investigational Site
city: Granada
country: Spain
facility: Novo Nordisk Investigational Site
city: Lugo
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Portugalete
country: Spain
facility: Novo Nordisk Investigational Site
city: San Adria del Besos
country: Spain
facility: Novo Nordisk Investigational Site
city: Santander
country: Spain
facility: Novo Nordisk Investigational Site
city: Santander
country: Spain
facility: Novo Nordisk Investigational Site
city: Tegueste
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Zaragoza
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: