Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes

Completed · Phase 4

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID

NCT01232491

Run by

Novo Nordisk A/S

People needed

611

Starts

2010-10-29

Expected to finish

2011-11-14

Last updated by the study team

2017-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Ozark, Alabama, United States
• Novo Nordisk Investigational Site — Anaheim, California, United States
• Novo Nordisk Investigational Site — Burlingame, California, United States
• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Fullerton, California, United States
• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Montclair, California, United States
• Novo Nordisk Investigational Site — National City, California, United States
• Novo Nordisk Investigational Site — Redlands, California, United States
• Novo Nordisk Investigational Site — Santa Ana, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Colorado Springs, Colorado, United States
• Novo Nordisk Investigational Site — Norwalk, Connecticut, United States
• Novo Nordisk Investigational Site — Bradenton, Florida, United States
• Novo Nordisk Investigational Site — Clearwater, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jupiter, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Pembroke Pines, Florida, United States
• Novo Nordisk Investigational Site — Pembroke Pines, Florida, United States
• Novo Nordisk Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.