NCT00799448

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of repaglinide combined with insulin NPH versus biphasic human insulin 30 alone in type 2 diabetics inadequately controlled with sulfonylurea (SU) +/ biguanide therapy

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
terminated

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

September 16, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

November 26, 2008

Last Update Submit

February 17, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    after 20 weeks of treatment

Secondary Outcomes (3)

  • Fasting blood glucose (FBG)

  • Incidence of hypoglycaemic episodes

  • Adverse events

Interventions

repaglinideDRUG
biphasic human insulin 30DRUG
insulin NPHDRUG

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HbA1c: 7.5-11.0% on current therapy
  • OHA (oral hypoglycaemic agent) treatment for a minimum of two years
  • BMI (body mass index): 25-32 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Athens, 15127, Greece

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

repaglinidebiphasic human insulin 30Insulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

September 16, 2003

Primary Completion

September 20, 2004

Study Completion

September 20, 2004

Last Updated

February 20, 2017

Record last verified: 2017-02

Locations

GR(1)