NCT01498913

Brief Summary

This study is conducted in Asia. The aim of this study is to review the safety and efficacy of Novonorm® (repaglinide) in post-marketing use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,841

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2001

Typical duration 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

August 30, 2001

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2005

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

3.6 years

First QC Date

December 21, 2011

Last Update Submit

February 17, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • HbA1c (glycosylated haemoglobin)

  • 2 hours postprandial blood glucose (2-hr PPBG)

  • Fasting blood glucose (FBG)

  • Body weight

Secondary Outcomes (1)

  • Adverse events

Study Arms (1)

Repaglinide

Drug: repaglinide

Interventions

repaglinideDRUG

Prescription with NovoNorm® 0.5mg, 1mg or 2mg tablets according to product labelling in daily clinical practice at the discretion of the physician

Repaglinide

Eligibility Criteria

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

Korean people with diabetes mellitus

You may qualify if:

  • Type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Seoul, 137-920, South Korea

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

repaglinide

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 21, 2011

First Posted

December 26, 2011

Study Start

August 30, 2001

Primary Completion

March 25, 2005

Study Completion

March 25, 2005

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

KR(1)