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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461577
• Other study ID #: LANTU_L_05477
• Secondary ID: U1111-1118-8753
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2011
• Last updated: January 29, 2013
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

1-2 weeks screening period, 24 weeks treatment period, 1 week follow-up period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• INSULIN GLARGINE HOE 901
Pharmaceutical form:solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Japan	Administrative office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline		24 weeks	No
Secondary	Responder rate (HbA1c levels <7%) without severe hypoglycemia		24 weeks	No
Secondary	Responder rate (HbA1c levels <6.5% and <7%)		24 weeks	No
Secondary	Changes of fasting plasma glucose (FPG) levels from baseline		24 weeks	No
Secondary	Changes of beta cell marker: C-peptide from baseline		24 weeks	No
Secondary	Changes of Lipid profile: Lipid profile from baseline		24 weeks	No
Secondary	Weight change from baseline		24 weeks	No
Secondary	Total insulin dose (per kg body weight)		24 weeks	No
Secondary	Evaluation of patient's treatment satisfaction		24 weeks	No
Secondary	Number of patients with hypoglycemia		up to 24 weeks	Yes
Secondary	Number of patients with treatment-emergent adverse events		up to 24 weeks	Yes