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Completed

NCT Number: NCT01709929

Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mississauga, L4W 4XI, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with type 1 or type 2 diabetes
  • Using a basal/bolus insulin regimen

Exclusion criteria

  • Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
  • Subjects who previously enrolled in this study
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients

Treatment and study plan

insulin detemir

Drug

Administered subcutaneously (s.c., under the skin). Dose individually adjusted.

Primary outcomes

  1. Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events

Secondary outcomes

  1. Number of adverse events (all and serious)

  2. Number of all hypoglycaemic events

  3. Change in weight

  4. HbA1c (glycosylated haemoglobin)

  5. Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Open Label, Nonrandomised, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Acronym: PREDICTIVE™

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 18, 2012
Registry last updated
Mar 3, 2016

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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