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OpenTrials
Completed

NCT Number: NCT00572806

Initiation of Insulin Aspart in Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate if using insulin aspart as start therapy will improve the efficacy on daytime blood glucose cycle profile in subjects 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

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes for at least 3 years
  • HbA1c greater than 8.0%
  • Body Mass Index (BMI) below 40.0 kg/m2
  • Inadequate treatment with diet and OADs
  • Never received treatment with insulin

Exclusion criteria

  • Type 1 diabetes
  • Known or suspected allergy to investigational product

Treatment and study plan

insulin aspart

Drug

Primary outcomes

  1. Blood glucose value

    Time frame: at 5 pm in a daytime blood glucose cycle profile

Secondary outcomes

  1. Evaluation of 24-hour blood glucose cycle

  2. HbA1c

  3. Hypoglycaemic episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Evaluation of the Initiation of Insulin Treatment Using Insulin Aspart on Blood Glucose Profile in Type 2 Diabetes Mellitus

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 13, 2007
Registry last updated
Feb 24, 2017

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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