Status:
COMPLETED
Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief 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 Ob...
Detailed Description
1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01461577
Start Date
November 1 2011
End Date
December 1 2012
Last Update
January 30 2013
Active Locations (1)
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1
Administrative office
Tokyo, Japan