Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care (RELIANCE)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
INSULIN GLARGINE (HOE901)
Oral Anti Diabetics (OAD)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- 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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
General Practitioner initiation with insulin glargine
Usual standard of care
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
Secondary Outcome Measures
Time required to reach the target HbA1c level of < or = 7%
The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0%
Decrease in mean HbA1c level
Decrease in mean Fasting Plasma Glucose (FPG)
Mean change in body weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00950534
Brief Title
Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care
Acronym
RELIANCE
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
due to poor recruitment
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief 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.
The secondary objective is to demonstrate the importance of GP initiation of insulin glargine for the treatment of T2DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General Practitioner initiation with insulin glargine
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual standard of care
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE (HOE901)
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Oral Anti Diabetics (OAD)
Intervention Description
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
Primary Outcome Measure Information:
Title
The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
Time Frame
From week 0 to week 24
Secondary Outcome Measure Information:
Title
Time required to reach the target HbA1c level of < or = 7%
Time Frame
From week 0 to week 24
Title
The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0%
Time Frame
From week 0 to week 24
Title
Decrease in mean HbA1c level
Time Frame
At week 24
Title
Decrease in mean Fasting Plasma Glucose (FPG)
Time Frame
At week 24
Title
Mean change in body weight
Time Frame
At week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Macquarie Park
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care
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