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Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes (PREDICTIVE™)

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ClinicalTrials.gov Identifier: NCT00504673
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

July 19, 2007
July 20, 2007
November 21, 2014
April 2005
December 2006   (Final data collection date for primary outcome measure)
Body weight loss [ Time Frame: after 26 weeks of treatment ]
Same as current
Complete list of historical versions of study NCT00504673 on ClinicalTrials.gov Archive Site
  • HbA1c
  • Incidence of hypoglycaemia
Same as current
Not Provided
Not Provided
 
Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes
Comparison of the Effect of Insulin Detemir Versus Insulin NPH Both With Insulin Aspart on Weight Change in Overweight and Obese Subjects With Type 2 Diabetes
This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin detemir
  • Drug: insulin NPH
  • Drug: insulin aspart
Not Provided
Fajardo Montañana C, Hernández Herrero C, Rivas Fernández M. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight Type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008 Aug;25(8):916-23. doi: 10.1111/j.1464-5491.2008.02483.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
277
272
December 2006
December 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HbA1c: 7.5-11.0%
  • BMI: 25-40 kg/m2

Exclusion Criteria:

  • Treatment with any OAD (Oral Antidiabetic Drugs) except metformin
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00504673
NN304-1659
2005-000976-42 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP