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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hypoglycemic Agents
Incretins

ClinicalTrials.gov processed this record on July 31, 2014