Status:
COMPLETED
Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
October 29 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2011
Estimated Enrollment :
611 Patients enrolled
Trial Details
Trial ID
NCT01232491
Start Date
October 29 2010
End Date
November 14 2011
Last Update
May 1 2017
Active Locations (112)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35233
2
Novo Nordisk Investigational Site
Ozark, Alabama, United States, 36360
3
Novo Nordisk Investigational Site
Anaheim, California, United States, 92801
4
Novo Nordisk Investigational Site
Burlingame, California, United States, 94010