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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00950534




Registration number
NCT00950534
Ethics application status
Date submitted
30/07/2009
Date registered
31/07/2009
Date last updated
10/11/2011

Titles & IDs
Public title
Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care
Scientific 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
Secondary ID [1] 0 0
LANTU_L_04264
Universal Trial Number (UTN)
Trial acronym
RELIANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - INSULIN GLARGINE (HOE901)
Treatment: Drugs - Oral Anti Diabetics (OAD)

Experimental: General Practitioner initiation with insulin glargine - 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.

Active comparator: Usual standard of care - 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)


Treatment: Drugs: 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)

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%
Timepoint [1] 0 0
From week 0 to week 24
Secondary outcome [1] 0 0
Time required to reach the target HbA1c level of < or = 7%
Timepoint [1] 0 0
From week 0 to week 24
Secondary outcome [2] 0 0
The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0%
Timepoint [2] 0 0
From week 0 to week 24
Secondary outcome [3] 0 0
Decrease in mean HbA1c level
Timepoint [3] 0 0
At week 24
Secondary outcome [4] 0 0
Decrease in mean Fasting Plasma Glucose (FPG)
Timepoint [4] 0 0
At week 24
Secondary outcome [5] 0 0
Mean change in body weight
Timepoint [5] 0 0
At week 24

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00950534
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00950534