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

• ClinicalTrials.gov Identifier: NCT01632163
• Recruitment Status: Completed
• First Posted: July 2, 2012
• Last Update Posted: June 15, 2015
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: June 26, 2012
• First Posted Date: July 2, 2012
• Last Update Posted Date: June 15, 2015
• Study Start Date: October 2012
• Actual Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 29, 2012): Change in HbA1c [ Time Frame: from baseline to week 24 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Mellitus

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 12, 2015): 447
• Original Estimated Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, India, Korea, Republic of, Russian Federation

Administrative Information

• NCT Number: NCT01632163
• Other Study ID Numbers: EFC12382; U1111-1124-1213 ( Other Identifier: UTN )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi
• Original Responsible Party: Same as current
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

• PRS Account: Sanofi
• Verification Date: June 2015