NCT00745433

Brief Summary

This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
906

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

September 1, 2008

Last Update Submit

October 31, 2023

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    After 12-20 weeks.

Secondary Outcomes (3)

  • PPG

    After 12-20 weeks.

  • Number of hypoglycemic events

    After 12-20 weeks.

  • Variability in FPG (Fasting Plasma Glucose)

    After 12-20 weeks.

Study Arms (1)

A

Repaglinide add-on to metformin.

Drug: repaglinideDrug: metformin

Interventions

repaglinideDRUG

Start dose and frequency at the discretion of the physician following clinical practice

Also known as: NovoNorm®
A
metforminDRUG

Start dose and frequency at the discretion of the physician following clinical practice

A

Eligibility Criteria

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

Any subject with type 2 diabetes treated with metformin

You may qualify if:

  • Type 2 diabetes
  • Metformin monotreatment
  • HbA1c greater than 7%
  • Treatment according to SPC
  • Informed consent obtained

You may not qualify if:

  • Any contraindication to the use of repaglinide (according to the SPC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

repaglinideMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 3, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations

BE(1)