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Completed

NCT Number: NCT00184626

Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin 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

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Istanbul, 111, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Body mass index equal to or lesser than 35.0 kg/m2
  • Currently treated with oral hypoglycaemic drug

Exclusion criteria

  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
  • Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results

Treatment and study plan

biphasic insulin aspart

Drug

insulin glargine

Drug

metformin

Drug

Primary outcomes

  1. HbA1c

    Time frame: Measured at end of treatment (26 weeks)

Secondary outcomes

  1. safety variables

  2. other glycemic variables

  3. Fasting plasma glucose value

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
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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