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OpenTrials
Completed

NCT Number: NCT00504673

Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

A Coruña, 15006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Treatment with any OAD (Oral Antidiabetic Drugs) except metformin

Treatment and study plan

insulin detemir

Drug

insulin NPH

Drug

insulin aspart

Drug

Primary outcomes

  1. Body weight loss

    Time frame: after 26 weeks of treatment

Secondary outcomes

  1. HbA1c

  2. Incidence of hypoglycaemia

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: PREDICTIVE™

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 20, 2007
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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