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OpenTrials
Completed

NCT Number: NCT01536600

Observational Study of Biphasic Insulin Aspart 30 Alone or in Combination With Oral Hypoglycaemic Agents in Subjects With Type 2 Diabetes

This study is conducted in Africa, Asia and Europe. The aim of this study is to investigate biphasic insulin aspart 30 (NovoMix® 30) alone or in combination with oral hypoglycaemic agent (OHA) for type 2 diabetes management in routine clinical practice.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Seoul, 137-920, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with type 2 diabetes whose glycaemia was not optimally controlled with current therapy

Treatment and study plan

biphasic insulin aspart 30

Drug

The insulin dose and regimen was individualised at the physician's discretion

Primary outcomes

  1. Change in HbA1c (glycosylated haemoglobin)

Secondary outcomes

  1. Change in post prandial glucose (PPG)

  2. Change in fasting glucose (FG)

  3. Difference in prandial glucose increment (PGI)

  4. Incidence of hypoglycaemic episodes

  5. Adverse drug reactions (ADR)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

Acronym: PRESENT

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 22, 2012
Registry last updated
Jan 6, 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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