Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: INSULIN GLARGINE (Drug); INSULIN GLULISINE (Drug); PREMIXED INSULIN (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
For site information, send an email with site number to, Email: Contact-Us@sanofi-aventis.com

Primary Objective:

To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3. 1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents.

Secondary Objectives:

To assess the effect of insulin glargine in comparison with premixed insulin on :

- Evolution of HbA1c level during the treatment period Percentage of patients who reach

the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3. 9 mmol/L)

- Percentage of patients who reach the target of HbA1c < 6. 5% and who do not experience

documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3. 1 mmol/L) >Percentage of patients who reach the target of HbA1c < 6. 5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3. 9 mmol/L) >Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles

- Evolution of weight

- Hypoglycemia occurrence

- Dose of insulins

- Evolution of liver function

- Overall safety

Official title: A 24-week, Open, Multicenter, Comparative Study of 2 Strategies (Including Insulin Glargine Versus Premixed Insulin) for the Therapeutic Management of Patients With Type 2 Diabetes Failing Oral Agents

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]

Secondary outcome:

7-point plasma glucose (PG) profile recorded on 3 consecutive days

Self-monitored PG (Plasma Glucose) values over 3 consecutive days

Self-monitored PG (Plasma Glucose) values over 3 consecutive days

Self-monitored PG (Plasma Glucose) values over 3 consecutive days

Weight and supine blood pressure

Insulin doses of the day before each visit

Biochemistry and lipid profile

Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Type 2 diabetes diagnosed for more than 1 year

- Insulin naïve

- Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin

at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months

- HbA1c ≥ 7. 0 % and ≤ 10. 5%

- Body mass index (BMI) ≤ 40 kg/m2

- Ability and willingness to perform plasma glucose (PG) monitoring using the

sponsor-provided glucose meter and to complete the patient diary

- Willingness and ability to comply with the study protocol

- Signed informed consent obtained prior any study procedure

Exclusion criteria:

- Treatment with glucagon-like peptide-1 (GLP-1) agonists in the 3 months prior to

study entry

- Previous treatment with insulin (except for treatment of gestational diabetes or

brief treatment with insulin for less than 1 week)

- Diabetes other than type 2 diabetes (e. g. type 1 diabetes, diabetes secondary to

pancreatic disorders, drug or chemical agent intake)

- Pregnant or lactating women (women of childbearing potential must have a negative

pregnancy test at study entry and a medically approved contraception method)

- Hospitalized patient (except for routine diabetes check-up)

- Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy

occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry

- History of sensitivity to the study drugs or to drugs with a similar chemical

structure

- Impaired renal function: creatinine clearance < 60ml/min

- Impaired liver function (ALT, AST > 3 x upper limit of normal range)

- Severe gastro-intestinal disease

- Treatment with corticosteroids with potential systemic action within the 3 months

prior to study entry

- Likelihood of requiring treatments during the study which are not permitted

- Treatment with an investigational product in the 30 days prior to study entry

- Alcohol or drug abuse within the last 5 years

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

For site information, send an email with site number to, Email: Contact-Us@sanofi-aventis.com

Investigational Site Number 040-004, Sankt Stefan A-8511, Austria; Active, not recruiting

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Starting date: June 2010
Last updated: September 23, 2011