Type 2 Diabetes Mellitus
Conditions
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 Objective: * To determine the change in glycemic control, safety, and treatment satisfaction in insulin glargine use in patients following GLP-1 failure.
Detailed description
1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period
Interventions
DRUGINSULIN GLARGINE HOE 901
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
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Responder rate (HbA1c levels <7%) without severe hypoglycemia | 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 |
| Weight change from baseline | 24 weeks |
Countries
Japan
Outcome results
None listed