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NCT01492166 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01492166
Other study ID # NOPEN3-1890
Secondary ID
Status Completed
Phase N/A
First received December 12, 2011
Last updated December 12, 2016
Start date November 2006
Est. completion date June 2007

Study information
Verified date December 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Indonesia: National Agency of Drug and Food Control
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1935
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Type 2 diabetes

- Not adequately controlled on their current therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Indonesia Novo Nordisk Investigational Site Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in fasting blood glucose (FBG) No
Primary Change in 2-hour post prandial blood glucose No
Primary Change in HbA1c (glycosylated haemoglobin) No
Primary Change in prandial glucose increment (PGI) No
Secondary Frequency of minor and major hypoglycaemia No
Secondary Occurrence of Adverse Drug Reactions (ADR) No
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