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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lixisenatide (AVE0010)
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 156001
  • Investigational Site Number 156033
  • Investigational Site Number 156006
  • Investigational Site Number 156005
  • Investigational Site Number 156004
  • Investigational Site Number 156002
  • Investigational Site Number 156016
  • Investigational Site Number 156025
  • Investigational Site Number 156014
  • Investigational Site Number 156013
  • Investigational Site Number 156034
  • Investigational Site Number 156035
  • Investigational Site Number 156021
  • Investigational Site Number 156023
  • Investigational Site Number 156017
  • Investigational Site Number 156026
  • Investigational Site Number 156029
  • Investigational Site Number 156019
  • Investigational Site Number 156020
  • Investigational Site Number 156018
  • Investigational Site Number 156028
  • Investigational Site Number 156007
  • Investigational Site Number 156032
  • Investigational Site Number 156009
  • Investigational Site Number 156036
  • Investigational Site Number 156010
  • Investigational Site Number 156008
  • Investigational Site Number 156027
  • Investigational Site Number 156011
  • Investigational Site Number 156012
  • Investigational Site Number 356019
  • Investigational Site Number 356018
  • Investigational Site Number 356026
  • Investigational Site Number 356017
  • Investigational Site Number 356002
  • Investigational Site Number 356024
  • Investigational Site Number 356015
  • Investigational Site Number 356008
  • Investigational Site Number 356021
  • Investigational Site Number 356023
  • Investigational Site Number 410003
  • Investigational Site Number 410007
  • Investigational Site Number 410006
  • Investigational Site Number 410001
  • Investigational Site Number 410005
  • Investigational Site Number 410002
  • Investigational Site Number 643007
  • Investigational Site Number 643006
  • Investigational Site Number 643003
  • Investigational Site Number 643004
  • Investigational Site Number 643005

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lixisenatide

Placebo

Arm Description

24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)

24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)

Outcomes

Primary Outcome Measures

Change in HbA1c

Secondary Outcome Measures

Percentage of patients with HbA1c <7%, =<6.5%
Change in 2-hour postprandial plasma glucose and plasma glucose excursion
Change in fasting plasma glucose
Change in 7-point self monitoring plasma glucose profile (average and each point)
Change in body weight
Change in daily basal insulin dose
Number of patients with adverse events
Anti-lixisenatide antibody assessment

Full Information

First Posted
June 26, 2012
Last Updated
June 12, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01632163
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lixisenatide
Arm Type
Experimental
Arm Description
24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Intervention Type
Drug
Intervention Name(s)
Lixisenatide (AVE0010)
Intervention Description
Pharmaceutical form:solution Route of administration: subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form:solution Route of administration: subcutaneous injection
Primary Outcome Measure Information:
Title
Change in HbA1c
Time Frame
from baseline to week 24
Secondary Outcome Measure Information:
Title
Percentage of patients with HbA1c <7%, =<6.5%
Time Frame
at week 24
Title
Change in 2-hour postprandial plasma glucose and plasma glucose excursion
Time Frame
from baseline to week 24
Title
Change in fasting plasma glucose
Time Frame
from baseline to week 24
Title
Change in 7-point self monitoring plasma glucose profile (average and each point)
Time Frame
from baseline to week 24
Title
Change in body weight
Time Frame
from baseline to week 24
Title
Change in daily basal insulin dose
Time Frame
from baseline to week 24
Title
Number of patients with adverse events
Time Frame
24 weeks
Title
Anti-lixisenatide antibody assessment
Time Frame
from baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 156001
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Investigational Site Number 156033
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Investigational Site Number 156006
City
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Investigational Site Number 156005
City
Beijing
ZIP/Postal Code
100700
Country
China
Facility Name
Investigational Site Number 156004
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Investigational Site Number 156002
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Investigational Site Number 156016
City
Changchun
ZIP/Postal Code
130041
Country
China
Facility Name
Investigational Site Number 156025
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Investigational Site Number 156014
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Investigational Site Number 156013
City
Chengdu
ZIP/Postal Code
610072
Country
China
Facility Name
Investigational Site Number 156034
City
Dalian
ZIP/Postal Code
116027
Country
China
Facility Name
Investigational Site Number 156035
City
Fuzhou
ZIP/Postal Code
354200
Country
China
Facility Name
Investigational Site Number 156021
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Investigational Site Number 156023
City
Haikou
ZIP/Postal Code
570311
Country
China
Facility Name
Investigational Site Number 156017
City
Harbin
ZIP/Postal Code
150001
Country
China
Facility Name
Investigational Site Number 156026
City
Jinan
ZIP/Postal Code
250012
Country
China
Facility Name
Investigational Site Number 156029
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Investigational Site Number 156019
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Investigational Site Number 156020
City
Nanjing
ZIP/Postal Code
210011
Country
China
Facility Name
Investigational Site Number 156018
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
Investigational Site Number 156028
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Investigational Site Number 156007
City
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Investigational Site Number 156032
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Investigational Site Number 156009
City
Shijiazhuang
ZIP/Postal Code
050051
Country
China
Facility Name
Investigational Site Number 156036
City
Siping
ZIP/Postal Code
136000
Country
China
Facility Name
Investigational Site Number 156010
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
Investigational Site Number 156008
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Investigational Site Number 156027
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Investigational Site Number 156011
City
Xi'An
ZIP/Postal Code
710032
Country
China
Facility Name
Investigational Site Number 156012
City
Xi'An
ZIP/Postal Code
710061
Country
China
Facility Name
Investigational Site Number 356019
City
Ahmedabad
ZIP/Postal Code
380008
Country
India
Facility Name
Investigational Site Number 356018
City
Aligarh
ZIP/Postal Code
202 002
Country
India
Facility Name
Investigational Site Number 356026
City
Bangalore
ZIP/Postal Code
560092
Country
India
Facility Name
Investigational Site Number 356017
City
Bhubaneswar
ZIP/Postal Code
751005
Country
India
Facility Name
Investigational Site Number 356002
City
Hyderabad
ZIP/Postal Code
500004
Country
India
Facility Name
Investigational Site Number 356024
City
Hyderabad
ZIP/Postal Code
500063
Country
India
Facility Name
Investigational Site Number 356015
City
Nagpur
ZIP/Postal Code
440012
Country
India
Facility Name
Investigational Site Number 356008
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Investigational Site Number 356021
City
Secunderabad
ZIP/Postal Code
500003
Country
India
Facility Name
Investigational Site Number 356023
City
Visakhapatnam
ZIP/Postal Code
530002
Country
India
Facility Name
Investigational Site Number 410003
City
Daegu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Investigational Site Number 410007
City
Goyang
ZIP/Postal Code
411-706
Country
Korea, Republic of
Facility Name
Investigational Site Number 410006
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Investigational Site Number 410001
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Investigational Site Number 410005
City
Seoul
ZIP/Postal Code
139-872
Country
Korea, Republic of
Facility Name
Investigational Site Number 410002
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Investigational Site Number 643007
City
Kirov
ZIP/Postal Code
610014
Country
Russian Federation
Facility Name
Investigational Site Number 643006
City
Samara
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
Investigational Site Number 643003
City
St-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number 643004
City
St-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number 643005
City
St-Petersburg
ZIP/Postal Code
195112
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
28742225
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.
Results Reference
derived

Learn more about this trial

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

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