Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial
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ClinicalTrials.gov Identifier: NCT00851903 |
Recruitment Status :
Completed
First Posted : February 26, 2009
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | February 25, 2009 | |||
First Posted Date ICMJE | February 26, 2009 | |||
Results First Submitted Date ICMJE | September 3, 2012 | |||
Results First Posted Date ICMJE | October 4, 2012 | |||
Last Update Posted Date | October 4, 2012 | |||
Study Start Date ICMJE | June 2009 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period) [ Time Frame: study endpoint: week 12 or earlier in case of premature discontinuation ] | |||
Original Primary Outcome Measures ICMJE |
Patients achieving glycosylated haemoglobin (HbA1c) < 7% [ Time Frame: At study endpoint ] | |||
Change History | Complete list of historical versions of study NCT00851903 on ClinicalTrials.gov Archive Site | |||
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 | Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial | |||
Official Title ICMJE | Combination Therapy of Insulin Glargine and Sitagliptin in Patients With Type 2 Diabetes Not Adequately Controlled by a Previous Treatment With Metformin and Either Insulin Glargine or Sitagliptin | |||
Brief Summary | This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled). All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria. The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period. The objectives of this extension study were:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type 2 | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Combination insulin glargine and sitagliptin
Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L). Sitagliptin: stable dose of 100 mg once a day administered with or without food. Interventions:
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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 |
112 | |||
Original Estimated Enrollment ICMJE |
530 | |||
Actual Study Completion Date ICMJE | September 2011 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 35 Years to 71 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 | Austria, Brazil, Colombia, Egypt, Greece, Hong Kong, India, Israel, Korea, Republic of, Lebanon, Mexico, Netherlands, Portugal, Spain, United Kingdom, United States | |||
Removed Location Countries | Turkey | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00851903 | |||
Other Study ID Numbers ICMJE | EXT_LANTU_C_02761 2008-000521-19 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | |||
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 | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |