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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01461577
First received: October 26, 2011
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: INSULIN GLARGINE HOE 901
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Responder rate (HbA1c levels <7%) without severe hypoglycemia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Responder rate (HbA1c levels <6.5% and <7%) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes of fasting plasma glucose (FPG) levels from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes of beta cell marker: C-peptide from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes of Lipid profile: Lipid profile from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Weight change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Total insulin dose (per kg body weight) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Evaluation of patient's treatment satisfaction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Number of patients with hypoglycemia [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients with treatment-emergent adverse events [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461577

Locations
Japan
Administrative office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01461577     History of Changes
Other Study ID Numbers: LANTU_L_05477, U1111-1118-8753
Study First Received: October 26, 2011
Last Updated: January 29, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
Glargine
Insulin
Insulin, Long-Acting
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Hypoglycemic Agents
Incretins

ClinicalTrials.gov processed this record on April 15, 2014