NCT01498900

Brief Summary

This study is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy, safety and convenience of using repaglinide (NovoNorm®) in type 2 diabetes management in routine clinical practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30,554

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2004

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 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5.5 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

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

December 21, 2011

Last Update Submit

October 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • HbA1c (glycosylated haemoglobin)

Secondary Outcomes (4)

  • Fasting Plasma Glucose (FPG)

  • Postprandial glucose values

  • Incidence of hypoglycaemia

  • Adverse drug reactions (ADR)

Study Arms (1)

Repaglinide

Drug: repaglinide

Interventions

Prescription according to the product labelling at the physicians' discretion

Repaglinide

Eligibility Criteria

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

Patients with type 2 diabetes, newly diagnosed or not adequately controlled on their current therapy, who are treated repaglinide by their physicians in accordance with the approved labeling

You may qualify if:

  • Type 2 diabetes
  • Newly diagnosed or not adequately controlled with current therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Istanbul, 34335, Turkey (Türkiye)

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 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

October 28, 2016

Record last verified: 2016-10

Locations