Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
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ClinicalTrials.gov Identifier: NCT01632163 |
Recruitment Status
:
Completed
First Posted
: July 2, 2012
Last Update Posted
: June 15, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | June 26, 2012 | |||
First Posted Date ICMJE | July 2, 2012 | |||
Last Update Posted Date | June 15, 2015 | |||
Study Start Date ICMJE | October 2012 | |||
Actual Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in HbA1c [ Time Frame: from baseline to week 24 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01632163 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin | |||
Brief Summary | Primary Objective: - To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients. Secondary Objectives:
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Detailed Description | Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up) | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Type 2 Diabetes Mellitus | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Yang W, Min K, Zhou Z, Li L, Xu X, Zhu D, Venkateshwar Rao A, Murthy LS, Zhang N, Li I, Niemoeller E, Shang S. Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial. Diabetes Obes Metab. 2018 Feb;20(2):335-343. doi: 10.1111/dom.13072. Epub 2017 Oct 5. | |||
* 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 |
447 | |||
Original Estimated Enrollment ICMJE |
432 | |||
Actual Study Completion Date | May 2015 | |||
Actual Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria : - Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin. Exclusion criteria: At screening:
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 |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China, India, Korea, Republic of, Russian Federation | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01632163 | |||
Other Study ID Numbers ICMJE | EFC12382 U1111-1124-1213 ( Other Identifier: UTN ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sanofi | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |