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

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ClinicalTrials.gov Identifier: NCT01461577
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE October 26, 2011
First Posted Date  ICMJE October 28, 2011
Last Update Posted Date January 30, 2013
Study Start Date  ICMJE November 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE Drug: INSULIN GLARGINE HOE 901
Pharmaceutical form:solution Route of administration: subcutaneous
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
89
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2011)
100
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461577
Other Study ID Numbers  ICMJE LANTU_L_05477
U1111-1118-8753 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP