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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632163
• Other study ID #: EFC12382
• Secondary ID: U1111-1124-1213
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2012
• Last updated: June 12, 2015
• Start date: October 2012
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Lixisenatide (AVE0010)
Pharmaceutical form:solution Route of administration: subcutaneous injection
• Placebo
Pharmaceutical form:solution Route of administration: subcutaneous injection

Locations

Country	Name	City	State
China	Investigational Site Number 156001	Beijing
China	Investigational Site Number 156002	Beijing
China	Investigational Site Number 156004	Beijing
China	Investigational Site Number 156005	Beijing
China	Investigational Site Number 156006	Beijing
China	Investigational Site Number 156033	Beijing
China	Investigational Site Number 156016	Changchun
China	Investigational Site Number 156025	Changsha
China	Investigational Site Number 156013	Chengdu
China	Investigational Site Number 156014	Chengdu
China	Investigational Site Number 156034	Dalian
China	Investigational Site Number 156035	Fuzhou
China	Investigational Site Number 156021	Guangzhou
China	Investigational Site Number 156023	Haikou
China	Investigational Site Number 156017	Harbin
China	Investigational Site Number 156026	Jinan
China	Investigational Site Number 156029	Jinan
China	Investigational Site Number 156019	Nanjing
China	Investigational Site Number 156020	Nanjing
China	Investigational Site Number 156018	Qingdao
China	Investigational Site Number 156007	Shanghai
China	Investigational Site Number 156028	Shanghai
China	Investigational Site Number 156032	Shenyang
China	Investigational Site Number 156009	Shijiazhuang
China	Investigational Site Number 156036	Siping
China	Investigational Site Number 156010	Suzhou
China	Investigational Site Number 156008	Tianjin
China	Investigational Site Number 156027	Wuhan
China	Investigational Site Number 156011	Xi'An
China	Investigational Site Number 156012	Xi'An
India	Investigational Site Number 356019	Ahmedabad
India	Investigational Site Number 356018	Aligarh
India	Investigational Site Number 356026	Bangalore
India	Investigational Site Number 356017	Bhubaneswar
India	Investigational Site Number 356002	Hyderabad
India	Investigational Site Number 356024	Hyderabad
India	Investigational Site Number 356015	Nagpur
India	Investigational Site Number 356008	Pune
India	Investigational Site Number 356021	Secunderabad
India	Investigational Site Number 356023	Visakhapatnam
Korea, Republic of	Investigational Site Number 410003	Daegu
Korea, Republic of	Investigational Site Number 410007	Goyang
Korea, Republic of	Investigational Site Number 410001	Seoul
Korea, Republic of	Investigational Site Number 410005	Seoul
Korea, Republic of	Investigational Site Number 410006	Seoul
Korea, Republic of	Investigational Site Number 410002	Wonju
Russian Federation	Investigational Site Number 643007	Kirov
Russian Federation	Investigational Site Number 643006	Samara
Russian Federation	Investigational Site Number 643003	St-Petersburg
Russian Federation	Investigational Site Number 643004	St-Petersburg
Russian Federation	Investigational Site Number 643005	St-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		from baseline to week 24	No
Secondary	Percentage of patients with HbA1c <7%, =<6.5%		at week 24	No
Secondary	Change in 2-hour postprandial plasma glucose and plasma glucose excursion		from baseline to week 24	No
Secondary	Change in fasting plasma glucose		from baseline to week 24	No
Secondary	Change in 7-point self monitoring plasma glucose profile (average and each point)		from baseline to week 24	No
Secondary	Change in body weight		from baseline to week 24	No
Secondary	Change in daily basal insulin dose		from baseline to week 24	No
Secondary	Number of patients with adverse events		24 weeks	Yes
Secondary	Anti-lixisenatide antibody assessment		from baseline to week 24	Yes