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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737776
First Posted: August 20, 2008
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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 ]

Secondary Outcome Measures:
  • Number of serious adverse drug reactions [ Time Frame: during the study ]
  • Number of serious adverse events [ Time Frame: during the study ]
  • Number of all major (daytime and nocturnal) hypoglycaemic events [ Time Frame: during the study ]
  • Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection [ Time Frame: during the study ]
  • Number of major hypoglycaemic events related to physical exercise of at least 30 min [ Time Frame: during the study ]
  • Number of all minor (daytime and nocturnal) hypoglycaemic events [ Time Frame: during the study ]
  • Weight (BMI) change [ Time Frame: at the end of study after 26 weeks ]
  • Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change [ Time Frame: at the end of study after 26 weeks ]
  • Percentage of patients reaching the target of HbA1c below or equal to 6.5% [ Time Frame: at the end of study after 26 weeks ]
  • Percentage of patients reaching the target of HbA1c below or equal to 7.0% [ Time Frame: at the end of study after 26 weeks ]
  • Percentage of patients reaching the physician's own target recommendation [ Time Frame: at the end of study after 26 weeks ]
  • Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level [ Time Frame: at the end of study after 26 weeks ]
  • Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level [ Time Frame: at the end of study after 26 weeks ]
  • Diabetes Fear of Self-Injection Questionnaire (D-FISQ) [ Time Frame: at the end of study after 26 weeks ]

Enrollment: 1068
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737776


Locations
Korea, Republic of
Novo Nordisk Investigational Site
Seoul, Korea, Republic of, 137-920
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00737776     History of Changes
Other Study ID Numbers: BIASP-3547
First Submitted: August 19, 2008
First Posted: August 20, 2008
Last Update Posted: October 31, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
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