Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

Tracking Information
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; (submitted: June 29, 2012)	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; (submitted: June 29, 2012)	Percentage of patients with HbA1c <7%, =<6.5% [ Time Frame: at week 24 ]; Change in 2-hour postprandial plasma glucose and plasma glucose excursion [ Time Frame: from baseline to week 24 ]; Change in fasting plasma glucose [ Time Frame: from baseline to week 24 ]; Change in 7-point self monitoring plasma glucose profile (average and each point) [ Time Frame: from baseline to week 24 ]; Change in body weight [ Time Frame: from baseline to week 24 ]; Change in daily basal insulin dose [ Time Frame: from baseline to week 24 ]; Number of patients with adverse events [ Time Frame: 24 weeks ]; Anti-lixisenatide antibody assessment [ Time Frame: from baseline to week 24 ]
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: To assess the effects of lixisenatide over 24 weeks on : percentage of patients reaching HbA1c<7% or ≤6.5%, 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profile), body weight, change in daily basal insulin dose.; To assess lixisenatide safety and tolerability.; To assess anti-lixisenatide antibody development.
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
Condition ICMJE	Type 2 Diabetes Mellitus
Intervention ICMJE	Drug: Lixisenatide (AVE0010) Pharmaceutical form:solution Route of administration: subcutaneous injection; Drug: Placebo Pharmaceutical form:solution Route of administration: subcutaneous injection
Study Arms	Experimental: Lixisenatide 24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day) Intervention: Drug: Lixisenatide (AVE0010); Placebo Comparator: Placebo 24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day) Intervention: Drug: Placebo
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 12, 2015)	447
Original Estimated Enrollment ICMJE; (submitted: June 29, 2012)	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: Age < legal age of adulthood.; HbA1c<7% or >10.5%.; Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.; If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.; History of hypoglycemia unawareness.; Body Mass Index (BMI) ≤20 kg/m².; Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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 )
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	Study Director: Clinical Sciences & Operations Sanofi
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