NCT00653302

Brief Summary

Primary objective:

  • Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c\<7% and/or a final decrease of HbA1c\>15% compare to the basal value (HbA1c final - HbA1c basal). Secondary objectives:
  • Determination of the predictive criterion of HbA1c final,
  • Determination of the predictive criterion of weight variation,
  • Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),
  • Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value). Safety:
  • Adverse Event (AE)/Serious Adverse Event (SAE) assessments

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Apr 2003

Typical duration for phase_4 type-2-diabetes

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, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
Last Updated

December 3, 2008

Status Verified

December 1, 2008

Enrollment Period

1.4 years

First QC Date

April 1, 2008

Last Update Submit

December 2, 2008

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • % of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

    During the study conduct

Secondary Outcomes (4)

  • Determination of the predictive criterion of HbA1c final

    During the study conduct

  • Determination of the predictive criterion of weight variation

    During all the study conduct

  • HbA1c and weight variations (final value - basal value)

    during the study

  • AE/SAE evaluation

    from the informed consent signed up to the end of the study

Study Arms (1)

1

EXPERIMENTAL

Lantus once a day plus Glucophage 1000mg, twice a day per os

Drug: Lantus (insulin glargine) + Glucophage (Metformin)

Interventions

Lantus (insulin glargine) + Glucophage (Metformin)DRUG
1

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known type 2 diabetes for at least 2 years
  • No history of Ketoacidosis
  • BMI\> 25 \& \<35 kg/m2
  • Type 2 diabetes treated with oral bi or tritherapy for at least 6 months
  • With insulin release stimulator: sulfonamide or glinide at maximal posology (as defined in the SmPC),
  • and metformin at minimal posology 1700mg/day (1320 mg of metformin),
  • HbA1c \>= 7.5 and \<11% for 2 different dosages during the last year

You may not qualify if:

  • Type 1 diabetes
  • Glucophage intolerability
  • Pregnancy
  • Breast feeding
  • Partial pancreatectomy
  • Hypersensitivity to insulin glargine excipient
  • Renal failure with creatinin\>135 µmol/L for male and \>110 µmol/L for female patient
  • Hepatitis with transaminases \>3ULN
  • Pre-proliferative or proliferative retinopathy
  • Acute cardiovascular accident within the last 6 months
  • Previous treatment with insulin within the last 6 months before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis administrative office

Paris, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin GlargineMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Nathalie Billon

    Sanofi-aventis administrative office France

    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 1, 2008

First Posted

April 4, 2008

Study Start

April 1, 2003

Primary Completion

September 1, 2004

Study Completion

October 1, 2005

Last Updated

December 3, 2008

Record last verified: 2008-12

Locations

FR(1)