Clinical trial NCT01632163: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-07-02
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Change in HbA1c
timeFrame: from baseline to week 24
Secondary outcomes:
measure: Percentage of patients with HbA1c <7%, =<6.5%
timeFrame: at week 24
measure: Change in 2-hour postprandial plasma glucose and plasma glucose excursion
timeFrame: from baseline to week 24
measure: Change in fasting plasma glucose
timeFrame: from baseline to week 24
measure: Change in 7-point self monitoring plasma glucose profile (average and each point)
timeFrame: from baseline to week 24
measure: Change in body weight
timeFrame: from baseline to week 24
measure: Change in daily basal insulin dose
timeFrame: from baseline to week 24
measure: Number of patients with adverse events
timeFrame: 24 weeks
measure: Anti-lixisenatide antibody assessment
timeFrame: from baseline to week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site Number 156001
city: Beijing
country: China
facility: Investigational Site Number 156033
city: Beijing
country: China
facility: Investigational Site Number 156006
city: Beijing
country: China
facility: Investigational Site Number 156005
city: Beijing
country: China
facility: Investigational Site Number 156004
city: Beijing
country: China
facility: Investigational Site Number 156002
city: Changchun
country: China
facility: Investigational Site Number 156016
city: Changsha
country: China
facility: Investigational Site Number 156025
city: Chengdu
country: China
facility: Investigational Site Number 156014
city: Chengdu
country: China
facility: Investigational Site Number 156013
city: Dalian
country: China
facility: Investigational Site Number 156034
city: Fuzhou
country: China
facility: Investigational Site Number 156035
city: Guangzhou
country: China
facility: Investigational Site Number 156021
city: Haikou
country: China
facility: Investigational Site Number 156023
city: Harbin
country: China
facility: Investigational Site Number 156017
city: Jinan
country: China
facility: Investigational Site Number 156026
city: Jinan
country: China
facility: Investigational Site Number 156029
city: Nanjing
country: China
facility: Investigational Site Number 156019
city: Nanjing
country: China
facility: Investigational Site Number 156020
city: Qingdao
country: China
facility: Investigational Site Number 156018
city: Shanghai
country: China
facility: Investigational Site Number 156028
city: Shanghai
country: China
facility: Investigational Site Number 156007
city: Shenyang
country: China
facility: Investigational Site Number 156032
city: Shijiazhuang
country: China
facility: Investigational Site Number 156009
city: Siping
country: China
facility: Investigational Site Number 156036
city: Suzhou
country: China
facility: Investigational Site Number 156010
city: Tianjin
country: China
facility: Investigational Site Number 156008
city: Wuhan
country: China
facility: Investigational Site Number 156027
city: Xi'An
country: China
facility: Investigational Site Number 156011
city: Xi'An
country: China
facility: Investigational Site Number 156012
city: Ahmedabad
country: India
facility: Investigational Site Number 356019
city: Aligarh
country: India
facility: Investigational Site Number 356018
city: Bangalore
country: India
facility: Investigational Site Number 356026
city: Bhubaneswar
country: India
facility: Investigational Site Number 356017
city: Hyderabad
country: India
facility: Investigational Site Number 356002
city: Hyderabad
country: India
facility: Investigational Site Number 356024
city: Nagpur
country: India
facility: Investigational Site Number 356015
city: Pune
country: India
facility: Investigational Site Number 356008
city: Secunderabad
country: India
facility: Investigational Site Number 356021
city: Visakhapatnam
country: India
facility: Investigational Site Number 356023
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Goyang
country: Korea, Republic of
facility: Investigational Site Number 410007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410005
city: Wonju
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Kirov
country: Russian Federation
facility: Investigational Site Number 643007
city: Samara
country: Russian Federation
facility: Investigational Site Number 643006
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643003
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643004
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643005
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.