Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes (UPGRADE)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00737776
First received: August 19, 2008
Last updated: August 30, 2012
Last verified: May 2012
  Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: NovoMix® 30 UPGRADE (NovoMix® 30 Use for Progressed Glycemic Control in Realistic Administration to DiabEtes Mellitus): A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Efficacy and Safety Study in Patients Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c change [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of serious adverse drug reactions [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Number of serious adverse events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Number of all major (daytime and nocturnal) hypoglycaemic events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Number of major hypoglycaemic events related to physical exercise of at least 30 min [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Number of all minor (daytime and nocturnal) hypoglycaemic events [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Weight (BMI) change [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]
  • Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients reaching the target of HbA1c below or equal to 6.5% [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients reaching the target of HbA1c below or equal to 7.0% [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients reaching the physician's own target recommendation [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]
  • Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]
  • Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]
  • Diabetes Fear of Self-Injection Questionnaire (D-FISQ) [ Time Frame: at the end of study after 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 1150
Study Start Date: May 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Other Names:
  • NovoMix® 30
  • NovoLog® Mix 70/30

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any patient with type 1 and type 2 diabetes who are prescribed with NovoMix® 30

Criteria

Inclusion Criteria:

  • Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
  • Patient who signed on informed consent form

Exclusion Criteria:

  • Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
  • Patients who were previously enrolled in this study
  • Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737776

Locations
Korea, Republic of
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Seon Young Lee, BS Novo Nordisk Pharma Korea, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00737776     History of Changes
Other Study ID Numbers: BIASP-3547
Study First Received: August 19, 2008
Last Updated: August 30, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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 aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014