Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care (RELIANCE)

This study has been terminated.
(due to poor recruitment)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00950534
First received: July 30, 2009
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: INSULIN GLARGINE (HOE901)
Drug: Oral Anti Diabetics (OAD)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0% [ Time Frame: From week 0 to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time required to reach the target HbA1c level of < or = 7% [ Time Frame: From week 0 to week 24 ] [ Designated as safety issue: No ]
  • The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0% [ Time Frame: From week 0 to week 24 ] [ Designated as safety issue: No ]
  • Decrease in mean HbA1c level [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
  • Decrease in mean Fasting Plasma Glucose (FPG) [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
  • Mean change in body weight [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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)
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)
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  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: NCT00950534

Locations
Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00950534     History of Changes
Other Study ID Numbers: LANTU_L_04264
Study First Received: July 30, 2009
Last Updated: November 9, 2011
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014