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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glucagon; Glucagon-Like Peptide 1; Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

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.