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.