Overview

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

Status:
Completed
Trial end date:
2017-11-27
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sanofi
Treatments:
Insulin
Insulin Glargine
Insulin, Globin Zinc
Criteria
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.