Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure

Study Overview
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Brief Summary
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Primary Objective: To assess the efficacy of insulin glargine as measured by changes of HbA1c levels from baseline in type 2 diabetes mellitus (T2DM) patients following GLP-1 failure. Secondary Objective: To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.

Detailed Description
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1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period

Official Title
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A Multicenter, Open-label, Single-arm, 24 Week Phase IV Study Evaluating the Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: INSULIN GLARGINE HOE 901


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients of aged ≥30 and ≤75 years with type 2 diabetes mellitus (T2DM) Hemoglobin A1c (glycosylated hemoglobin; HbA1c) levels measured at screening ≥7.5% Continuous treatment with stable doses of GLP-1 analogue for >3 months prior to enrollment (for patients also using oral anti-hyperglycemic drugs [OADs], continuous treatment with stable doses of OADs for >3 months prior to enrollment) Exclusion criteria: Inpatient with T2DM Diabetes other than T2DM (e.g. secondary to pancreatic disorders, drug or chemical agent intake) Fasting plasma glucose (FPG) levels <130mg/dL Body mass index (BMI) >28 kg/m2 Patients using thiazolidinediones in the last 3 months prior to enrollment Use of any treatment for weight loss in the last 3 months prior to enrollment Treatment with systemic corticosteroids within the 3 months prior to enrollment Patients using non-selective ß-blockers Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol Most recent ophthalmologic examination >6 months prior to enrollment Diabetic retinopathy with surgical treatment (last photocoagulation or vitrectomy) in the 3 months before enrollment or which may require surgical treatment Proliferative diabetic retinopathy or any other unstable rapidly progressive retinopathy Impaired renal function defined as, but not limited to, serum creatinine ≥1.3 mg/dL [males] or ≥1.2 mg/dL [females] or presence of macroproteinuria (>1 g/day) Active liver disease including hepatic cirrhosis, hepatic failure, and hepatitis or alanine transaminase (ALT) or aspartate aminotransferase (AST) >2 times upper limit or total bilirubin >1.5 times upper limit of normal (except in case of Gilbert's syndrome) at enrollment Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol Any medical condition that may have an influence on HbA1c rate Currently undergoing therapy for malignancy which may affect the study evaluation Use of any investigational product and/or device within the 2 months prior to enrollment History of ketoacidosis or hyperosmolar hyperglycemic state during the previous 12 months prior to enrollment History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within the previous 12 months prior to enrollment History of congestive heart failure History of hypoglycemia unawareness or unexplained hypoglycemia during the previous 12 months prior to enrollment Hemoglobinopathy or hemolytic anemia, transfusion of blood or plasma products within 3 months prior to enrollment Known hypersensitivity / intolerance to insulin glargine or any of its excipients History of pancreatitis Pregnant or breast-feeding women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) Shift workers or those who regularly work a night-time shift 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: 30 Years
Maximum Age: 75 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: insulin glargine<br>Insulin glargine will be administered once a day, in the morning, at initial dose of 4 units/day. Titration of insulin dose will be performed referred with the median fasting plasma glucose value for the last 3 consecutive days according to the titration algorithm | Drug: INSULIN GLARGINE HOE 901<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate (HbA1c levels <7%) without severe hypoglycemia |  | 24 weeks | 
| Responder rate (HbA1c levels <6.5% and <7%) |  | 24 weeks | 
| Changes of fasting plasma glucose (FPG) levels from baseline |  | 24 weeks | 
| Changes of beta cell marker: C-peptide from baseline |  | 24 weeks | 
| Changes of Lipid profile: Lipid profile from baseline |  | 24 weeks | 
| Weight change from baseline |  | 24 weeks | 
| Total insulin dose (per kg body weight) |  | 24 weeks | 
| Evaluation of patient's treatment satisfaction |  | 24 weeks | 
| Number of patients with hypoglycemia |  | up to 24 weeks | 
| Number of patients with treatment-emergent adverse events |  | up to 24 weeks |