NCT01487421

Brief Summary

This study is conducted in Europe. The aim of this study is investigate the potential of a supplementary insulin therapy regimen (SIT) as intensification for insufficiently controlled patients with type 2 diabetes in a normal diabetes care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,134

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2003

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

July 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

3.3 years

First QC Date

November 25, 2011

Last Update Submit

June 23, 2014

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c (glycosylated haemoglobin)

Secondary Outcomes (5)

  • Fasting blood glucose (FBG)

  • 2-hours postprandial blood glucose

  • Hypoglycemia

  • Weight development

  • Adverse Drug Reactions (ADRs) including Serious Adverse Drug Reactions (SADRs)

Study Arms (1)

SIT

Drug: insulin aspartDrug: insulin detemir

Interventions

insulin aspartDRUG

Subjects were observed over a time period of 12 weeks after initiation of a supplementary insulin therapy regimen (SIT) with insulin aspart at mealtimes. Administrated subcutaneously (s.c., under the skin)

SIT
insulin detemirDRUG

Insulin detemir were added to insulin aspart in the evening or at bedtime, if needed. Administrated subcutaneously (s.c., under the skin)

SIT

Eligibility Criteria

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

Patients with insufficiently controlled type 2 diabetes mellitus treated with diet, OAD (oral anti-diabetes drug), long acting insulin, premixed insulin or a combination

You may qualify if:

  • Type 2 diabetes
  • OAD monotherapy
  • OAD combination therapy
  • Therapy with OAD and basal insulin
  • Conventional insulin therapy with premixed insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mainz, 55127, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin AspartInsulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

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

November 25, 2011

First Posted

December 7, 2011

Study Start

July 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

DE(1)