NCT00349986

Brief Summary

The rationale of the study is to determine:

  • the first dose and the titration of basal insulin
  • the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

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

First Submitted

Initial submission to the registry

July 7, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

9 months

First QC Date

July 7, 2006

Last Update Submit

December 4, 2009

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HgbA1c measurement

Interventions

Insuline glargineDRUG

Eligibility Criteria

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

You may qualify if:

  • Type 2 Diabetes Mellitus
  • Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
  • BMI \>25 kg/m2 , \<30 kg/m2
  • HbA1c value \>7.0%, \<9.0% within one month

You may not qualify if:

  • Type 1 Diabetes Mellitus
  • Known malignancy
  • Drug or alcohol abuse
  • Severe liver disease
  • Renal failure (se Creatinine \> 150 micro mol/l)
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Budapest, Hungary

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • László Erős, MD

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 10, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2007

Last Updated

December 7, 2009

Record last verified: 2009-12

Locations

HU(1)