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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01492166

Enrollment

1935

Registered

2011-12-14

Start date

2006-11-30

Completion date

2007-06-30

Last updated

2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGbiphasic 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Frequency of minor and major hypoglycaemia	—
Occurrence of Adverse Drug Reactions (ADR)	—

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026