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Completed

NCT Number: NCT00789711

An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes

This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philippines.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Manila, 1605, Philippines

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with type 1 or type 2 diabetes mellitus
  • Patients uncontrolled on oral antidiabetic drugs
  • Insulin naïve patients or patients currently on human insulin

Exclusion criteria

  • Subjects who are unlikely to comply with protocol requirements
  • Subjects who are previously enrolled in NovoMix® 30 and Levemir™ study
  • Subjects on NovoMix® 30 and Levemir™ therapy
  • Subjects with hypersensitivity to NovoMix® 30 or to any of the excipients
  • Subjects with hypersensitivity to Levemir™ or to any of the excipients
  • Females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice
  • Contraindications and warnings specified in the current prescribing information

Treatment and study plan

biphasic insulin aspart 30

Drug

Evaluation of the safety profile and effectiveness of biphasic insulin aspart 30 in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines

Other names: NovoMix® 30, BIASP

insulin detemir

Drug

Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines

Primary outcomes

  1. Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.

    Time frame: during 12 months of treatment

Secondary outcomes

  1. HbA1c

    Time frame: at the end of the study

  2. FBG (Fasting Blood Glucose)

    Time frame: at the end of the study

  3. Average (mean) fasting plasma glucose level

    Time frame: at the end of the study

  4. Number of minor (including nocturnal) hypoglycaemic events

    Time frame: during 12 months of treatment

  5. Number of major (including nocturnal) hypoglycaemic events

    Time frame: during 12 months of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Open-label, Nonrandomised, Non-interventional, Observational Study to Compare Safety and Effectiveness of Biphasic Insulin Aspart 30 (NovoMix 30) and Insulin Detemir (Levemir) for the Treatment of Diabetes Mellitus

Acronym: SAFE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2008
Registry last updated
Oct 31, 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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