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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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01492166
First received: December 12, 2011
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

  Eligibility

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).

Criteria

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

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

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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
 Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013