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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00715663
First received: July 14, 2008
Last updated: December 12, 2016
Last verified: December 2016
  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 ]
  • Change in post-prandial glucose (PPG) [ Time Frame: after 12 weeks of therapy ]
  • Change in fasting plasma glucose (FPG) [ Time Frame: after 12 weeks of therapy ]
  • Change in prandial glucose increment (PGI) [ Time Frame: after 12 weeks of therapy ]
  • Incidence of hypoglycaemia and other adverse drug reaction [ Time Frame: after 12 weeks of therapy ]
  • Patient and doctor's convenience [ Time Frame: after 12 weeks of therapy ]

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 ]
  • Patient satisfaction on devices [ Time Frame: after 12 weeks of treatment ]

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Novo Nordisk Investigational Site
Jakarta, Indonesia, 12520
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: NCT00715663     History of Changes
Other Study ID Numbers: NOPEN3-1891
Study First Received: July 14, 2008
Last Updated: December 12, 2016

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, Isophane
Biphasic Insulins
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2017