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Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes (PREDICTIVE™)
This study has been completed.
Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk
ClinicalTrials.gov Identifier: NCT00504673
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: insulin detemir
Drug: insulin NPH
Drug: insulin aspart
 Phase III

MedlinePlus related topics: Diabetes Obesity
Drug Information available for: Insulin Insulin aspart Insulin Detemir Insulin, isophane
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Body weight loss [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Designated as safety issue: No ]
  • Incidence of hypoglycaemia [ Designated as safety issue: No ]

Estimated Enrollment: 272
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Treatment with any OAD (Oral Antidiabetic Drugs) except metformin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504673

Locations
Spain
La Coruña, Spain, 15006
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Fernando Fuentes, PhD Novo Nordisk Pharma S.A.
  More Information

Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
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.

Responsible Party: Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers: NN304-1659, EudraCT No: 2005-000976-42
Study First Received: July 19, 2007
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00504673  
Health Authority: Spain: Spanish Agency of Medicines

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin, Isophane
Insulin
 Body Weight
Diabetes Mellitus, Type 2
Body Weight Changes
Insulin, Asp(B28)-
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009



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