Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure (GAUDI)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
INSULIN GLARGINE HOE 901
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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.
Sites / Locations
- Administrative office
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
insulin glargine
Arm Description
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
Outcomes
Primary Outcome Measures
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
Secondary Outcome Measures
Responder rate (HbA1c levels <7%) without severe hypoglycemia
Responder rate (HbA1c levels <6.5% and <7%)
Changes of fasting plasma glucose (FPG) levels from baseline
Changes of beta cell marker: C-peptide from baseline
Changes of Lipid profile: Lipid profile from baseline
Weight change from baseline
Total insulin dose (per kg body weight)
Evaluation of patient's treatment satisfaction
Number of patients with hypoglycemia
Number of patients with treatment-emergent adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01461577
Brief Title
Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
Acronym
GAUDI
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
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
insulin glargine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE HOE 901
Intervention Description
Pharmaceutical form:solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Responder rate (HbA1c levels <7%) without severe hypoglycemia
Time Frame
24 weeks
Title
Responder rate (HbA1c levels <6.5% and <7%)
Time Frame
24 weeks
Title
Changes of fasting plasma glucose (FPG) levels from baseline
Time Frame
24 weeks
Title
Changes of beta cell marker: C-peptide from baseline
Time Frame
24 weeks
Title
Changes of Lipid profile: Lipid profile from baseline
Time Frame
24 weeks
Title
Weight change from baseline
Time Frame
24 weeks
Title
Total insulin dose (per kg body weight)
Time Frame
24 weeks
Title
Evaluation of patient's treatment satisfaction
Time Frame
24 weeks
Title
Number of patients with hypoglycemia
Time Frame
up to 24 weeks
Title
Number of patients with treatment-emergent adverse events
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Administrative office
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
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