Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan
Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan
Primary Objective:

 -To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes
 patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin
 glargine).

 Secondary Objectives:

 -  To evaluate the percentage of patients achieving target of HbA1c ˂7%.

 -  To evaluate the change in fasting plasma glucose (FPG).

 -  To assess the following safety criteria: hypoglycemic events, body weight changes, and
 overall safety.

 -  Describe the titration process: changes in glargine insulin dose at 3 months and 6
 months, changes in the titration doses used (if any), and time to reach control.
The total duration of study period per patient is up to 6 months.
Inclusion criteria :

 -  Patient ≥ 18 years old.

 -  Male or Female.

 -  Type 2 diabetes patients.

 -  Uncontrolled with previous therapy (HbA1c >7%), evident in HbA1c test within the last
 1 month before study entry.

 -  Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines
 of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic
 agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD
 combination), at maximum tolerated dose in the last 3 months.

 -  Signed informed consent.

 -  Signed informed consent.

 Exclusion criteria:

 -  Patient not willing or not able to perform self-monitoring blood glucose.

 -  Patient not willing or not able to self-titrate insulin glargine under physician's
 guidance.

 -  Patient not suitable for participation according to what is specified in the approved
 Summary of Product's Characteristics or according to medical or clinical conditions,
 as judged by the Investigator.

 -  History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or
 aspartate aminotransferase (AST) greater than three times the upper limit of normal,
 evident in testing done in the last 3 months.

 -  History of impaired renal function defined as serum creatinine >135 μmol/L (>1.525
 mg/dL)in men and >110 μmol/L (>1.243 mg/dL) in women, evident in testing done in the
 last 3 months.

 -  Pregnant or lactating women (women of childbearing potential must have a negative
 pregnancy test at study entry and a medically approved contraception method at
 physician's discretion).

 -  Treatment with systemic corticosteroid within 3 months prior to study entry.

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