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
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
Tracking Information | ||||
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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 |
Efficacy assessment of insulin glargine measured by changes of HbA1c levels from baseline [ Time Frame: 24 weeks ] | |||
Original Primary Outcome Measures ICMJE |
Efficacy assessment of insuline glargine measured by changes of HbA1c levels from baseline [ Time Frame: 24 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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:
Secondary Objective:
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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 | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Type 2 Diabetes Mellitus | |||
Intervention ICMJE | Drug: INSULIN GLARGINE HOE 901
Pharmaceutical form:solution Route of administration: subcutaneous
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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
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
89 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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Sex/Gender ICMJE |
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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 ) |
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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 |
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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 |