Diabetes Mellitus, Type 2Phase 3OSIRISNCT00174642
Opposing Step-by-step Insulin Reinforcement to Intensified Strategy
A Phase 3 study testing Insulin Glargine, Insulin Glulisine and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 18 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Glargine, Insulin Glulisine and Metformin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 811 participants
- Where
- 18 sitesin 18 countries
- Study dates
- Dec 2004to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
18 sites in 18 countries.
18 sites in 18 countries
About this study
Official title: 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.
Read more
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
- Being tested
- Insulin Glargine, Insulin Glulisine, Metformin, insulin secretagogue
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
One daily injection in the evening. 100 U/ml
Insulin GlulisineDrug
Given immediately before each of the three main meals. 100 U/ml
MetforminDrug
At same dosages as the previous treatment
insulin secretagogueDrug
sulfonylurea or glinide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin Receives: Drug: Insulin Glargine; Drug: Insulin Glulisine; Drug: Metformin |
| 2 | Experimental | Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin Receives: Drug: Insulin Glargine; Drug: Insulin Glulisine; Drug: Metformin |
| 3 | Experimental | Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue Receives: Drug: Insulin Glargine; Drug: Insulin Glulisine; Drug: Metformin; Drug: insulin secretagogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: From the beginning to the end of the study
24-hour blood glucose levels
Measured: From the beginning to the end of the study
symptomatic hypoglycemia (diurnal and nocturnal)
Measured: From the beginning to the end of the study
Severe hypoglycemia (diurnal and nocturnal),
Measured: From the beginning to the end of the study
Insulin doses
Measured: From the beginning to the end of the study
Secondary outcomes (2)
Vital signs
Measured: From the beginning to the end of the study
Adverse events
Measured: From the beginning to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 811 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Valérie Pilorget, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174642
- Sponsor's protocol ID
- HMR1964A_3506
- Other IDs
- EUDRACT # : 2004-002036-25
- Acronym
- OSIRIS
- Status last verified
- Sep 2009
- First submitted
- 9 Sep 2005
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs
- ClinicalTrials.gov ID
- NCT00174642
- Acronym / sponsor ID
- OSIRIS / HMR1964A_3506
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 811 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Dec 2008 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Insulin Glargine, Drug: Insulin Glulisine, Drug: MetforminInsulin Glargine + 3 bolus of Insulin Glulisine + Metformin |
| 2 | Experimental | Drug: Insulin Glargine, Drug: Insulin Glulisine, Drug: MetforminInsulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin |
| 3 | Experimental | Drug: Insulin Glargine, Drug: Insulin Glulisine, Drug: Metformin, Drug: insulin secretagogueInsulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin GlargineOne daily injection in the evening. 100 U/ml | Drug | 1, 2, 3 |
| Insulin GlulisineGiven immediately before each of the three main meals. 100 U/ml | Drug | 1, 2, 3 |
| MetforminAt same dosages as the previous treatment | Drug | 1, 2, 3 |
| insulin secretagoguesulfonylurea or glinide | Drug | 3 |
Primary outcome
HbA1c
Time frame: 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
symptomatic hypoglycemia (diurnal and nocturnal)
Time frame: 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
Insulin doses
Time frame: From the beginning to the end of the study
2 secondary outcomes
Vital signs
Time frame: From the beginning to the end of the study
Adverse events
Time frame: From the beginning to the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Pilorget, MD study director
Sanofi
18 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin Glargine, Insulin Glulisine and Metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 18 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Belgium, France, Germany, Greece, Hungary and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: From the beginning to the end of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009; AzTrials last refreshed its copy on 6 Nov 2026.