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Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00715663
First received: July 14, 2008
Last updated: May 23, 2012
Last verified: May 2012
History of Changes
  Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate safety, efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal clinical practice conditions.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix® 30 FlexPen® as Monotherapy, or in Combination With OHA, in Treatment of Type 2 Diabetic Patients in Routine Clinical Practice: A Post-Marketing Surveillance Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: No ]
  • Change in post-prandial glucose (PPG) [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: No ]
  • Change in prandial glucose increment (PGI) [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemia and other adverse drug reaction [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: Yes ]
  • Patient and doctor's convenience [ Time Frame: after 12 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practice [ Time Frame: For the duration of the study ] [ Designated as safety issue: No ]
  • Patient satisfaction on devices [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 1584
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: biphasic insulin aspart 30
No intervention is done. For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation
Other Name: NovoMix® 30

  Eligibility

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

All patients with type 2 diabetes, inadequately controlled on their current therapy, who are prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labelling.

Criteria

Inclusion Criteria:

  • All patients with type 2 diabetes, not adequately controlled on their current therapy, who were prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labeling, are eligible for the survey.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715663

Locations
Indonesia
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Sri Indriastuti Soetomo, MD Novo Nordisk Indonesia
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00715663     History of Changes
Other Study ID Numbers: NOPEN3-1891
Study First Received: July 14, 2008
Last Updated: May 23, 2012
Health Authority: Indonesia: National Agency of Drug and Food Control

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

ClinicalTrials.gov processed this record on May 21, 2013