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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: INSULIN GLARGINE HOE 901

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: INSULIN GLARGINE HOE 901; Pharmaceutical form:solution Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Responder rate (HbA1c levels <7%) without severe hypoglycemia	24 weeks
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
Weight change from baseline	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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (Estimate): October 28, 2011

Study Record Updates

• Last Update Posted (Estimate): January 30, 2013
• Last Update Submitted That Met QC Criteria: January 29, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: LANTU_L_05477; U1111-1118-8753 (Other Identifier: UTN)