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

Study Overview
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Brief Summary
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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
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The total duration of study period per patient is up to 6 months.

Official Title
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Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: INSULIN GLARGINE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HOE901<br>HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels | Drug: INSULIN GLARGINE<br>* Pharmaceutical form:Solution Route of administration: Subcutaneous<br>* Other names: HOE901;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Percentage of patients achieving target of HbA1c <7% |  | 6 months | 
| - 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 | 
| - Number of patients with adverse events |  | Baseline, 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 |