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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00504673
First Posted: July 20, 2007
Last Update Posted: November 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Body weight loss [ Time Frame: after 26 weeks of treatment ]

Secondary Outcome Measures:
  • HbA1c
  • Incidence of hypoglycaemia

Enrollment: 277
Study Start Date: April 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504673


Locations
Spain
La Coruña, Spain, 15006
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00504673     History of Changes
Other Study ID Numbers: NN304-1659
2005-000976-42 ( EudraCT Number )
First Submitted: July 19, 2007
First Posted: July 20, 2007
Last Update Posted: November 21, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Overweight
Diabetes Mellitus, Type 2
Body Weight Changes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Aspart
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs