A 26-week Randomised, Controlled, Open Label, Multicentre, Multinational, Treat to Target Trial Investigating the Impact of Dietary Intervention on Weight Change and the Relationship Between Weight Change and Baseline Body Mass Index (BMI) in Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) Initiating Insulin Therapy With Insulin Detemir in Combination With Metformin (Levemir DIET)

CompletadoFase 4ClinicalTrials.gov

ID: NCT01232491Tipo: INTERVENTIONALInicio: 29 de oct de 2010Fin estimado: 14 de nov de 2011

Traducción no disponible, mostrando original

Resumen

This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes (diagnosed clinically) for at least 6 months prior trial start
Insulin naive subjects
HbA1c: 7.0-9.0 % (both inclusive)
Body Mass Index (BMI): 25.0-45.0 kg/m\^2 (both inclusive)

Criterios de exclusión

Use of Thiazolidinedione (TZDs) or Glucagon-like peptide-1 analogue (GLP- 1) receptor agonists within the last 3 months prior to trial enrollment
Cardiovascular disease within the last 6 months
Recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
Uncontrolled treated/untreated severe hypertension, impaired liver function, impaired renal function, known proliferative retinopathy or maculopathy requiring treatment
Cancer and medical history of cancer in the past 5 years (except basal cell skin cancer or squamous cell skin cancer)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

Intervenciones

drug

Insulin detemir

Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.

dietary_supplement

Dietary regimen

Subjects receive dietary consultation by a dietician at six occasions during the trial.

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Caba, Argentina

Novo Nordisk Investigational Site

Capital Federal, Argentina

Novo Nordisk Investigational Site

Córdoba, Argentina

Novo Nordisk Investigational Site

Godoy Cruz, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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