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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

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ClinicalTrials.gov Identifier: NCT01492166
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : December 13, 2016
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic human insulin 30

Study Type : Observational
Actual Enrollment : 1935 participants
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
Study Start Date : November 2006
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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).

Inclusion Criteria:

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

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): NCT01492166

Novo Nordisk Investigational Site
Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01492166     History of Changes
Other Study ID Numbers: NOPEN3-1890
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 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
Hypoglycemic Agents
Physiological Effects of Drugs