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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174642
First received: September 9, 2005
Last updated: September 14, 2009
Last verified: September 2009
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Drug: Insulin Glulisine
Drug: Metformin
Drug: insulin secretagogue
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • HbA1c [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • 24-hour blood glucose levels [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • symptomatic hypoglycemia (diurnal and nocturnal) [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Severe hypoglycemia (diurnal and nocturnal), [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Insulin doses [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vital signs [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Enrollment: 811
Study Start Date: December 2004
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174642

  Show 18 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valérie Pilorget, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00174642     History of Changes
Other Study ID Numbers: HMR1964A_3506, EUDRACT # : 2004-002036-25
Study First Received: September 9, 2005
Last Updated: September 14, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Insulin
Insulin glulisine
Insulin, Globin Zinc
Insulin, Long-Acting
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014