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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)

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

October 26, 2011
January 29, 2013
November 2011
December 2012   (final data collection date for primary outcome measure)
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Efficacy assessment of insuline glargine measured by changes of HbA1c levels from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01461577 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 insuline 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 ]
Not Provided
Not Provided
 
Effectiveness and Safety of Treatment of Insulin Glargine in Type 2 Diabetes Mellitus Following Glucagon-like Peptide-1 (GLP-1) Failure
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.

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

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: INSULIN GLARGINE HOE 901
Pharmaceutical form:solution Route of administration: subcutaneous
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
December 2012
December 2012   (final data collection date for primary outcome measure)

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.

Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01461577
LANTU_L_05477, U1111-1118-8753
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2013

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