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.
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: December 12, 2011
Last updated: April 11, 2012
Last verified: April 2012

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 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) [ Designated as safety issue: No ]
  • Change in 2-hour post prandial blood glucose [ Designated as safety issue: No ]
  • Change in HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
  • Change in prandial glucose increment (PGI) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of minor and major hypoglycaemia [ Designated as safety issue: No ]
  • Occurrence of Adverse Drug Reactions (ADR) [ Designated as safety issue: No ]

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


Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492166

Jakarta, Indonesia, 12520
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Corporate Vice President for diabetes and devices Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: April 11, 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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014