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 A/S
ClinicalTrials.gov Identifier:
NCT00715663
First received: July 14, 2008
Last updated: May 23, 2012
Last verified: May 2012
  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:


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

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
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: NCT00715663

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

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

ClinicalTrials.gov processed this record on September 18, 2014