Opposing Step-by-step Insulin Reinforcement to Intensified Strategy (OSIRIS)

September 14, 2009 updated by: Sanofi

Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

811

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Sanofi-Aventis
  • France
      • Paris, France
        • Sanofi-Aventis
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis
  • Greece
      • Athens, Greece
        • Sanofi-Aventis
  • Hungary
      • Budapest, Hungary
        • Sanofi-Aventis
  • Ireland
      • Dublin, Ireland
        • Sanofi-Aventis
  • Italy
      • Milan, Italy
        • Sanofi-Aventis
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Sanofi-Aventis
  • Lithuania
      • Vilnius, Lithuania
        • Sanofi-Aventis
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis
  • Poland
      • Warsaw, Poland
        • Sanofi-Aventis
  • Russian Federation
      • Moscow, Russian Federation
        • Sanofi-Aventis
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis
  • Sweden
      • Stockholm, Sweden
        • Sanofi-Aventis
  • Taiwan
      • Taipei, Taiwan
        • Sanofi-Aventis
  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis
  • United Kingdom
      • Guildford, United Kingdom
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Type 2 diabetic
  • BMI ≤ 40 kg/m²
  • HbA1c > 7%
  • Treated with basal insulin (NPH, Insulin Zinc, insulin glargine or insulin detemir), and at least, two OAD including an insulin secretagogue (sulfonylurea or glinide, at any dosage) and metformin (at the maximum tolerated dosage), for more than 6 months

Exclusion criteria:

  • Type 1 diabetes mellitus
  • Treatment with OADs only
  • Treatment with thiazolidinediones
  • Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
  • Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (confirmed by an optic fundus performed in the 2 years prior study entry)
  • Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
  • Breast-feeding
  • History of hypersensitivity to the study drug or to drugs with a similar chemical structure or to insulin glargine
  • Treatment with systemic corticosteroids, irrespective of the dose of administration and irrespective of the prior or foreseeable treatment duration
  • Treatment with any investigational product in the last 2 months before study entry, except for insulin glargine
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
  • Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
  • Impaired hepatic function as shown by ALT and/or AST greater than three times the upper limit of normal at study entry
  • Impaired renal function as shown by serum creatinine >135 μmol/l in men and > 110 μmol/l in women at study entry
  • History of drug or alcohol abuse
  • Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
  • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
  • Subject deprived of freedom by a judicial or administrative decision
  • Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin
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
Experimental: 2
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin
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
Experimental: 3
Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: From the beginning to the end of the study
From the beginning to the end of the study
24-hour blood glucose levels
Time Frame: From the beginning to the end of the study
From the beginning to the end of the study
symptomatic hypoglycemia (diurnal and nocturnal)
Time Frame: From the beginning to the end of the study
From the beginning to the end of the study
Severe hypoglycemia (diurnal and nocturnal),
Time Frame: From the beginning to the end of the study
From the beginning to the end of the study
Insulin doses
Time Frame: From the beginning to the end of the study
From the beginning to the end of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: From the beginning to the end of the study
From the beginning to the end of the study
Vital signs
Time Frame: From the beginning to the end of the study
From the beginning to the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR1964A_3506
  • EUDRACT # : 2004-002036-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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