Diabetes Mellitus, Type 2
Conditions
Brief 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.
Detailed description
The total duration of study period per patient is up to 6 months.
Interventions
DRUGINSULIN GLARGINE
Pharmaceutical form:Solution Route of administration: Subcutaneous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c | Baseline, 6 months |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in fasting plasma glucose values | Baseline, 3 months, and 6 months |
| - Percentage of patients with hypoglycemic events | Baseline, 6 months |
| - Change from baseline in body weight | Baseline, 3 months and 6 months |
| - Percentage of patients achieving target of HbA1c <7% | 6 months |
| - Change in dose of insulin glargine | 3 months and 6 months |
| - Change in the titration doses used (if any) | 6 months |
| - Time to reach control | 6 months |
| - Number of patients with adverse events | Baseline, 6 months |
Countries
Jordan
Outcome results
None listed