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

NCT00950534 | Terminated Phase 4

• 1 other identifier: LANTU_L_04264
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%

  From week 0 to week 24

Secondary Outcomes (5)

• Time required to reach the target HbA1c level of < or = 7%

  From week 0 to week 24

• The percentage of patients achieving two consecutive on treatment HbA1c measurements of < or = 7.0%

  From week 0 to week 24

• Decrease in mean HbA1c level

  At week 24

• Decrease in mean Fasting Plasma Glucose (FPG)

  At week 24

• Mean change in body weight

  At week 24

Study Arms (2)

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.

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)

Drug: Oral Anti Diabetics (OAD)

Interventions

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)

General Practitioner initiation with insulin glargine

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

Usual standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Macquarie Park, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Hypoglycemic Agents

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: July 31, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

AU (1)