NCT00322075

Brief Summary

Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_4 diabetes-mellitus

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

April 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

September 12, 2007

Status Verified

September 1, 2007

First QC Date

April 27, 2006

Last Update Submit

September 11, 2007

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (7)

  • 3 days continual glycaemic profile fluctuation

  • occurrence of adverse events

  • HbA1c

  • FBG

  • BMI

  • total daily dose of insulin and ratio of doses of basal/prandial insulines

  • patients´satisfaction

Interventions

insulin glargineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year

You may not qualify if:

  • Diabetic ketoacidosis
  • Any other severe disease
  • Pregnancy or fertile female without contraception
  • Alcohol/drug abuse, selected prohibited concomitant medication
  • Nightshift work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Prague, Czechia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

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

  • Zuzana Priborska

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 27, 2006

First Posted

May 4, 2006

Study Start

April 1, 2006

Study Completion

November 1, 2006

Last Updated

September 12, 2007

Record last verified: 2007-09

Locations

CZ(1)