NCT01492166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,935

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

7 months

First QC Date

December 12, 2011

Last Update Submit

December 12, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Frequency of minor and major hypoglycaemia

  • Occurrence of Adverse Drug Reactions (ADR)

Study Arms (1)

Novolet®

Drug: biphasic human insulin 30

Interventions

biphasic human insulin 30DRUG

Dose and timing of dose for each subject was at the discretion of the attending physicians based on current clinical practice guidelines

Novolet®

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

biphasic human insulin 30

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

November 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

ID(1)