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Opposing Step-by-step Insulin Reinforcement to Intensified Strategy

NCT00174642 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 811

Last updated 2009-09-15

No results posted yet for this study

Summary

Primary objectives :

* To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
* To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.

Secondary objectives :

* To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c \<= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin Glargine

One daily injection in the evening. 100 U/ml

DRUG

Insulin Glulisine

Given immediately before each of the three main meals. 100 U/ml

DRUG

Metformin

At same dosages as the previous treatment

DRUG

insulin secretagogue

sulfonylurea or glinide

Sponsors & Collaborators

Principal Investigators

  • Valérie Pilorget, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-12-31

Countries

  • Belgium
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00174642 on ClinicalTrials.gov