Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

PHASE4CompletedINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

February 23, 2017

Primary Completion Date

August 4, 2017

Study Completion Date

August 4, 2017

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

Lixisenatide (AVE0010)

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

DRUG

Sulfonylurea

"Pharmaceutical form: tablet~Route of administration: oral"

DRUG

metformin

"Pharmaceutical form: tablet~Route of administration: oral"

DRUG

basal insulin

"Pharmaceutical form: solution for injection~Route of administration: subcutaneous"

Trial Locations (16)

13100

Investigational Site Number 376002, Safed

31096

Investigational Site Number 376001, Haifa

380007

Investigational Site Number 356005, Ahmedabad

400007

Investigational Site Number 356014, Mumbai

440010

Investigational Site Number 356022, Nagpur

500001

Investigational Site Number 356009, Hyderabad

500004

Investigational Site Number 356018, Hyderabad

500072

Investigational Site Number 356010, Hyderabad

500095

Investigational Site Number 356003, Hyderabad

560043

Investigational Site Number 356002, Bangalore

560055

Investigational Site Number 356015, Bangalore

560060

Investigational Site Number 356008, Bangalore

625020

Investigational Site Number 356019, Madurai

Unknown

Investigational Site Number 356007, Jaipur

Investigational Site Number 414001, Kuwait City

Investigational Site Number 792002, Zonguldak

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY