NCT00174681

Brief Summary

Primary objective: The primary objective of this trial is:

  • To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and dietary measures in type 2 diabetics whose blood glucose control is acceptable but not optimal on maximum oral treatment, based on the number of patients achieving a HbA1c value \< 7% at the end of treatment. Secondary objectives: The secondary objectives of this trial are to compare between the two treatment groups:
  • The variation in HbA1c between baseline and end of trial.
  • The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia.
  • Mean blood glucose levels at different times of the day.
  • The variation in weight and lipid in each group between baseline and end of trial.
  • The incidence of adverse events.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Geographic Reach
6 countries

6 active sites

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
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

First QC Date

September 9, 2005

Last Update Submit

January 10, 2011

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects achieving HbA1c < 7% at the end of the study.

Interventions

Insulin GlargineDRUG

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes
  • ≤ BMI ≤ 35 kg/m2
  • % ≤ HbA1c ≤ 8 %
  • Treated with OAD for at least 2 years
  • Treated with at least two oral antidiabetics including one sulphonylurea at the maximum tolerated dosages and metformin at the maximum tolerated dosages
  • Not treated with a glinide or thiazolidinedione.
  • Capable of performing blood glucose self-monitoring and a self-injection of insulin.

You may not qualify if:

  • Patient with any of the following criteria will not be included in the trial:
  • Type 1 diabetics
  • Insulin-treated type 2 diabetics or having previously received long-term insulin, or treated with a thiazolidinedione or glinide
  • Fasting blood glucose \< 1.20 g/l.
  • Lactation.
  • History of hypersensitivity to the investigational product or to drugs with similar chemical structures.
  • Systemic treatment with corticosteroids irrespective of the dose and irrespective of the previous or anticipated duration of treatment.
  • Subject likely to receive treatments prohibited in the protocol during the trial.
  • Cardiovascular, hepatic, neurological, endocrine or any other disease making it difficult to carry out the protocol or interpret the results.
  • Hepatic impairment:ALT and/or AST more than three times the upper limit of normal at the initial assessment.
  • Renal insufficiency:Serum creatinine \>177 µmol/l (\>20 mg/l) or creatinine clearance \<60 ml/min.
  • Previous or current history of alcohol or drug abuse.
  • Mental state rendering the subject incapable of understanding the nature, objectives and possible consequences of the trial.
  • Inability to undertake blood glucose self-monitoring and the injection of insulin alone.
  • Subject unable to accept the restrictions of the protocol (uncooperative, unable to attend the follow-up visits and probably incapable of completing the trial).
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sanofi-Aventis

Zagreb, Croatia

Location

Sanofi-Aventis

Prague, Czechia

Location

Sanofi-Aventis

Paris, France

Location

Sanofi-Aventis

Bucharest, Romania

Location

Sanofi-Aventis

Moscow, Russia

Location

Sanofi-Aventis

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

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 Proteins

Study Officials

  • Valérie Pilorget, 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

September 9, 2005

First Posted

September 15, 2005

Study Start

April 1, 2003

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

FR(1)CR(1)SL(1)RU(1)RO(1)CZ(1)