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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: July 19, 2007
Last updated: November 20, 2014
Last verified: November 2014
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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)

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

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
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Please refer to this study by its identifier: NCT00504673

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S Identifier: NCT00504673     History of Changes
Other Study ID Numbers: NN304-1659  2005-000976-42 
Study First Received: July 19, 2007
Last Updated: November 20, 2014
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Body Weight Changes
Diabetes Mellitus
Diabetes Mellitus, Type 2
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Insulin Aspart
Insulin Detemir
Insulin, Globin Zinc
Insulin, Isophane
Isophane Insulin, Human
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 26, 2016