NCT00709917

Brief Summary

This study is conducted in Europe. The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
2,171

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2007

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

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

March 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

June 30, 2008

Last Update Submit

March 2, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • Safety (number of hypoglycaemic incidents)

    After 10-20 weeks

  • HbA1C

    After 10-20 weeks

Secondary Outcomes (4)

  • safety

    After 10-20 weeks

  • posology

    After 10-20 weeks

  • lifestyle

    After 10-20 weeks

  • FBG

    After 10-20 weeks

Study Arms (1)

A

Drug: repaglinide

Interventions

repaglinideDRUG

Start dose and freqency to be prescribed by the physician at his discretion following clinical practice

Also known as: AGEE, Prandin®
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Type 2 diabetic patients having failed on metformin monotherapy

You may qualify if:

  • Type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose
  • Signed informed consent
  • Treatment in accordance with the summary of product characterisation

You may not qualify if:

  • Any contraindication to metformin or repaglinide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Brussels, 1070, Belgium

Location

Unknown Facility

Luxembourg, Luxembourg

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
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2008

First Posted

July 3, 2008

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

LU(1)BE(1)