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

• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: October 26, 2011
• First Posted Date: October 28, 2011
• Last Update Posted Date: January 30, 2013
• Study Start Date: November 2011
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 3, 2011): Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline [ Time Frame: 24 weeks ]
• Original Primary Outcome Measures (submitted: October 27, 2011): Efficacy assessment of insuline glargine measured by changes of HbA1c levels from baseline [ Time Frame: 24 weeks ]
• Change History: Complete list of historical versions of study NCT01461577 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 3, 2011)

• Responder rate (HbA1c levels <7%) without severe hypoglycemia [ Time Frame: 24 weeks ]
• Responder rate (HbA1c levels <6.5% and <7%) [ Time Frame: 24 weeks ]
• Changes of fasting plasma glucose (FPG) levels from baseline [ Time Frame: 24 weeks ]
• Changes of beta cell marker: C-peptide from baseline [ Time Frame: 24 weeks ]
• Changes of Lipid profile: Lipid profile from baseline [ Time Frame: 24 weeks ]
• Weight change from baseline [ Time Frame: 24 weeks ]
• Total insulin dose (per kg body weight) [ Time Frame: 24 weeks ]
• Evaluation of patient's treatment satisfaction [ Time Frame: 24 weeks ]
• Number of patients with hypoglycemia [ Time Frame: up to 24 weeks ]
• Number of patients with treatment-emergent adverse events [ Time Frame: up to 24 weeks ]

Original Secondary Outcome Measures (submitted: October 27, 2011)

• Responder rate (HbA1c levels <7%) without severe hypoglycemia [ Time Frame: 24 weeks ]
• Responder rate (HbA1c levels <6.5% and <7%) [ Time Frame: 24 weeks ]
• Changes of fasting plasma glucose (FPG) levels from baseline [ Time Frame: 24 weeks ]
• Changes of beta cell marker: C-peptide from baseline [ Time Frame: 24 weeks ]
• Changes of Lipid profile: Lipid profile from baseline [ Time Frame: 24 weeks ]
• Weight change from baseline [ Time Frame: 24 weeks ]
• Total insuline dose (per kg body weight) [ Time Frame: 24 weeks ]
• Evaluation of patient's treatment satisfaction [ Time Frame: 24 weeks ]
• Number of patients with hypoglycemia [ Time Frame: up to 24 weeks ]
• Number of patients with treatment-emergent adverse events [ Time Frame: up to 24 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Mellitus

Intervention

Drug: INSULIN GLARGINE HOE 901

Pharmaceutical form:solution Route of administration: subcutaneous

Study Arms

Experimental: insulin glargine

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: Drug: INSULIN GLARGINE HOE 901

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 22, 2013): 89
• Original Estimated Enrollment (submitted: October 27, 2011): 100
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01461577
• Other Study ID Numbers: LANTU_L_05477; U1111-1118-8753 ( Other Identifier: UTN )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sanofi
• Study Sponsor: Sanofi
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

• PRS Account: Sanofi
• Verification Date: January 2013