Clinical trial NCT01461577: Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 89
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: Responder rate (HbA1c levels <7%) without severe hypoglycemia
timeFrame: 24 weeks
measure: Responder rate (HbA1c levels <6.5% and <7%)
timeFrame: 24 weeks
measure: Changes of fasting plasma glucose (FPG) levels from baseline
timeFrame: 24 weeks
measure: Changes of beta cell marker: C-peptide from baseline
timeFrame: 24 weeks
measure: Changes of Lipid profile: Lipid profile from baseline
timeFrame: 24 weeks
measure: Weight change from baseline
timeFrame: 24 weeks
measure: Total insulin dose (per kg body weight)
timeFrame: 24 weeks
measure: Evaluation of patient's treatment satisfaction
timeFrame: 24 weeks
measure: Number of patients with hypoglycemia
timeFrame: up to 24 weeks
measure: Number of patients with treatment-emergent adverse events
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Administrative office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: