Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01492166
First received: December 12, 2011
Last updated: December 12, 2016
Last verified: December 2016
  Purpose
This study is conducted in Asia. The aim of this study is to assess the efficacy, safety and convenience of the use of Mixtard® 30 NovoLet® used alone or combined with oral hypoglycaemic agent (OHA) in the management of type 2 diabetes mellitus in an out-patient setting.

Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic human insulin 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 Mixtard® 30 NovoLet® as Monotherapy, or in Combination With Oral Hypoglycaemic Agent ( OHA ), in Treatment of Subjects With Type 2 Diabetes in Routine Clinical Practice

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in fasting blood glucose (FBG)
  • Change in 2-hour post prandial blood glucose
  • Change in HbA1c (glycosylated haemoglobin)
  • Change in prandial glucose increment (PGI)

Secondary Outcome Measures:
  • Frequency of minor and major hypoglycaemia
  • Occurrence of Adverse Drug Reactions (ADR)

Enrollment: 1935
Study Start Date: November 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Novolet® Drug: biphasic human insulin 30
Dose and timing of dose for each subject was at the discretion of the attending physicians based on current clinical practice guidelines

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with type 2 diabetes not achieving adequate control and being prescribed Mixtard® 30 Novolet® either as a single treatment or in combination with oral hypoglycaemic agents (OHAs).
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Not adequately controlled on their current therapy
  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: NCT01492166

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: NCT01492166     History of Changes
Other Study ID Numbers: NOPEN3-1890 
Study First Received: December 12, 2011
Last Updated: December 12, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin, pork; isophane insulin, pork drug combination 30:70
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 19, 2017