Diabetes Mellitus, Type 2Phase 4RELIANCENCT00950534
Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care
A Phase 4 study testing INSULIN GLARGINE (HOE901) and Oral Anti Diabetics (OAD) in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Australia.
Trial summary
The primary objective is to demonstrate the improvement in glycosylated haemoglobin (HbA1c) levels after general practitioner (GP) initiation and management of type 2 diabetes mellitus (T2DM) with insulin glargine compared with their usual clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- INSULIN GLARGINE (HOE901) and Oral Anti Diabetics (OAD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2009to Aug 2010
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 Diabetes Mellitus (T2DM)
- HbA1c > or = 7.5%, or HbA1c < or = 10%
- Continuous oral antidiabetic (OAD) treatment for more or equal than three months before randomisation with stable daily doses of one or more OADs (if on two or more OADs, one must be less or equal than half maximum tolerated dose)
- Willing and able to perform blood glucose monitoring using a blood glucose meter
- Willing and able to keep a daily patient diary
- Willing and able to provide written informed consent before enrolment in the study
Who cannot join
- Type 1 diabetes mellitus
- Body mass index (BMI) > 45 kg/m²
- Works night shifts
- History of ketoacidosis or hyperosmolar hyperglycaemic state
- History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months
- History of congestive heart failure
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- Hypoglycaemia unawareness
- Have had more than one episode of hypoglycaemia (per protocol definition) within 24 weeks before screening
- Impaired renal function defined as, but not limited to, serum creatinine > or = 1.5 mg/dL (133 µmol/L) males or > or = 1.4 mg/dL (124 µmol/L) females
- Active liver disease (alanine transaminase (ALT) greater than two times the upper limit of the reference range, as defined by the local laboratory)
- Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol
- Had a blood transfusion or severe blood loss within the 3 months before screening, or have known haemoglobinopathy, haemolytic anaemia or sickle cell anaemia
- Current or previous use of insulin
- Known hypersensitivity / intolerance to insulin glargine or any of its excipients
- Have taken exenatide in the six weeks before screening or for a total of 30 days or more in the 24 weeks before screening
- Currently receiving treatment with non-selective -blockers
- Currently receiving chronic (longer than two weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the four weeks preceding the screening visit
- Currently undergoing therapy or planned radiological examinations requiring the administration of contrasting agents for malignancy (other than non-metastatic / early stage basal cell or squamous cell carcinoma).
- Currently participating in another investigational study or recent study participation ending < 30 days before screening
- Female patients who are pregnant or breastfeeding
- Female patients of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be willing to agree to use a medically accepted contraceptive regimen for the duration of the study.
- 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
1 site in 1 country.
About this study
Official title: A Randomised, Multicentre, Open-Label, Parallel-Group, 24-Week Phase IV Study Comparing the Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care: General Practitioner Initiation of Insulin Glargine Versus the Usual Standard of Care
The primary objective is to demonstrate the improvement in glycosylated haemoglobin (HbA1c) levels after general practitioner (GP) initiation and management of type 2 diabetes mellitus (T2DM) with insulin glargine compared with their usual clinical practice.
The secondary objective is to demonstrate the importance of GP initiation of insulin glargine for the treatment of T2DM.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- INSULIN GLARGINE (HOE901), Oral Anti Diabetics (OAD)
- 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 GLARGINE (HOE901)Drug
The dose of insulin glargine will be titrated toward a fasting plasma glucose (FPG) target of 5.5 mmol/L. Treatment with oral antidiabetic drugs (OADs) prescribed before study entry may continue (except Sitagliptin, Acarbose, Rosiglitazone)
Oral Anti Diabetics (OAD)Drug
Patients treated with the usual standard of care (OAD dose titration, addition of a second or third OAD or referral to an endocrinologist) until optimal doses are reached to maintain a FPG of 5.5 mmol/L
| Study group | Role | What they receive |
|---|---|---|
| General Practitioner initiation with insulin glargine | Experimental | Patients will be prescribed insulin glargine by their Investigator and they will be taught how to administer insulin glargine according to Australian guidelines. Patients will be treated for 24 weeks. Receives: Drug: INSULIN GLARGINE (HOE901) |
| Usual standard of care | Active comparator | Patients will be treated by their Investigator with the usual standard of care for 24 weeks (e.g., OAD dose titration, addition of a second or third OAD, or referral to an endocrinologist) Receives: Drug: Oral Anti Diabetics (OAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
Measured: From week 0 to week 24
Secondary outcomes (5)
Time required to reach the target HbA1c level of < or = 7%
Measured: From week 0 to week 24
The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0%
Measured: From week 0 to week 24
Decrease in mean HbA1c level
Measured: At week 24
Decrease in mean Fasting Plasma Glucose (FPG)
Measured: At week 24
Mean change in body weight
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: due to poor recruitment
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950534
- Sponsor's protocol ID
- LANTU_L_04264
- Acronym
- RELIANCE
- Status last verified
- Nov 2011
- First submitted
- 30 Jul 2009
- Last updated
- 10 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multicentre, Open-Label, Parallel-Group, 24-Week Phase IV Study Comparing the Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care: General Practitioner Initiation of Insulin Glargine Versus the Usual Standard of Care
- ClinicalTrials.gov ID
- NCT00950534
- Acronym / sponsor ID
- RELIANCE / LANTU_L_04264
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to poor recruitment
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 Jul 2009 (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.
The primary objective is to demonstrate the improvement in glycosylated haemoglobin (HbA1c) levels after general practitioner (GP) initiation and management of type 2 diabetes mellitus (T2DM) with insulin glargine compared with their usual clinical practice.
The secondary objective is to demonstrate the importance of GP initiation of insulin glargine for the treatment of T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Practitioner initiation with insulin glargine | Experimental | Drug: INSULIN GLARGINE (HOE901)Patients will be prescribed insulin glargine by their Investigator and they will be taught how to administer insulin glargine according to Australian guidelines. Patients will be treated for 24 weeks. |
| Usual standard of care | Active comparator | Drug: Oral Anti Diabetics (OAD)Patients will be treated by their Investigator with the usual standard of care for 24 weeks (e.g., OAD dose titration, addition of a second or third OAD, or referral to an endocrinologist) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 2 Diabetes Mellitus (T2DM)
- HbA1c > or = 7.5%, or HbA1c < or = 10%
- Continuous oral antidiabetic (OAD) treatment for more or equal than three months before randomisation with stable daily doses of one or more OADs (if on two or more OADs, one must be less or equal than half maximum tolerated dose)
- Willing and able to perform blood glucose monitoring using a blood glucose meter
- Willing and able to keep a daily patient diary
Key exclusion criteria (22 listed)
- Type 1 diabetes mellitus
- Body mass index (BMI) > 45 kg/m²
- Works night shifts
- History of ketoacidosis or hyperosmolar hyperglycaemic state
- History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months
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 GLARGINE (HOE901)The dose of insulin glargine will be titrated toward a fasting plasma glucose (FPG) target of 5.5 mmol/L. Treatment with oral antidiabetic drugs (OADs) prescribed before study entry may continue (except Sitagliptin, Acarbose, Rosiglitazone) | Drug | General Practitioner initiation with insulin glargine |
| Oral Anti Diabetics (OAD)Patients treated with the usual standard of care (OAD dose titration, addition of a second or third OAD or referral to an endocrinologist) until optimal doses are reached to maintain a FPG of 5.5 mmol/L | Drug | Usual standard of care |
Primary outcome
The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
Time frame: From week 0 to week 24
5 secondary outcomes
Time required to reach the target HbA1c level of < or = 7%
Time frame: From week 0 to week 24
The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0%
Time frame: From week 0 to week 24
Decrease in mean HbA1c level
Time frame: At week 24
Decrease in mean Fasting Plasma Glucose (FPG)
Time frame: At week 24
Mean change in body weight
Time frame: At week 24
Results and safety
The study was stopped early (reason given: due to poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2011.
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing INSULIN GLARGINE (HOE901) and Oral Anti Diabetics (OAD) in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Australia.
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 6 inclusion and 22 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: stopped early, as of the sponsor's last update on 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: due to poor recruitment). Results are not available in the source record.
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?
The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0% (time frame: From week 0 to week 24). 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 10 Nov 2011.