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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00789711
First received: November 10, 2008
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions. [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • FBG (Fasting Blood Glucose) [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Average (mean) fasting plasma glucose level [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
  • Number of minor (including nocturnal) hypoglycaemic events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]
  • Number of major (including nocturnal) hypoglycaemic events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 2589
Study Start Date: November 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
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
B Drug: insulin detemir
Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any subject with diabetes mellitus who needs insulin treatment at the time of inclusion is eligible for the study, including newly diagnosed subjects who have never received insulin or an insulin analogue before

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789711

Locations
Philippines
Manilla, Philippines, 1605
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Love Taganas, BSc Pharm Novo Nordisk Pharmaceuticals (Philippines), Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00789711     History of Changes
Other Study ID Numbers: BIASP-3682
Study First Received: November 10, 2008
Last Updated: June 15, 2012
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart
Insulin
Insulin, Long-Acting
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014