Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s)

PHASE3TerminatedINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

November 9, 2018

Primary Completion Date

November 20, 2020

Study Completion Date

January 4, 2021

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Efpeglenatide SAR439977

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Background therapy

Lantus (Insulin Glargine), SC, once daily; OADs, administered as per investigator prescription and in accordance with local labeling.

Trial Locations (47)

11765

Investigational Site Number 4100013, Gyeonggi-do

12553

Investigational Site Number 8400039, New Windsor

13620

Investigational Site Number 4100007, Seongnam-si

14647

Investigational Site Number 4100006, Seoul

16247

Investigational Site Number 4100012, Suwon

21565

Investigational Site Number 4100015, Incheon

28557

Investigational Site Number 8400036, Morehead City

30044

Investigational Site Number 8400025, Lawrenceville

32825

Investigational Site Number 8400055, Orlando

33026

Investigational Site Number 8400041, Pembroke Pines

35211

Investigational Site Number 8400038, Birmingham

35233

Investigational Site Number 4100001, Daejeon

40503

Investigational Site Number 8400044, Lexington

43537

Investigational Site Number 8400013, Maumee

49241

Investigational Site Number 4100009, Busan

50265

Investigational Site Number 8400052, West Des Moines

54907

Investigational Site Number 4100014, Jeonju

61453

Investigational Site Number 4100010, Gwangju

75230

Investigational Site Number 8400030, Dallas

78229

Investigational Site Number 8400043, San Antonio

84041

Investigational Site Number 8400037, Layton

85224

Investigational Site Number 8400035, Chandler

85306

Investigational Site Number 8400005, Glendale

90057

Investigational Site Number 8400009, Los Angeles

90255

Investigational Site Number 8400057, Huntington Park

91405

Investigational Site Number 8400026, Van Nuys

91978

Investigational Site Number 8400045, Spring Valley

92037

Investigational Site Number 8400058, La Jolla

92780

Investigational Site Number 8400040, Tustin

100730

Investigational Site Number 1560017, Beijing

200032

Investigational Site Number 1560036, Shanghai

200040

Investigational Site Number 1560012, Shanghai

Investigational Site Number 1560013, Shanghai

410013

Investigational Site Number 1560006, Changsha

450003

Investigational Site Number 1560003, Zhengzhou

501757

Investigational Site Number 4100016, Gwangju

610083

Investigational Site Number 1560001, Chengdu

08302

Investigational Site Number 8400001, Bridgeton

75390-9302

Investigational Site Number 8400063, Dallas

014010

Investigational Site Number 1560005, Baotou

Investigational Site Number 1560004, Shanghai

02447

Investigational Site Number 4100008, Seoul

03080

Investigational Site Number 4100002, Seoul

03722

Investigational Site Number 4100005, Seoul

05278

Investigational Site Number 4100004, Seoul

06351

Investigational Site Number 4100003, Seoul

07345

Investigational Site Number 4100011, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hanmi Pharmaceutical Company Limited

INDUSTRY

lead

Sanofi

INDUSTRY

NCT03713684 - Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s) | Biotech Hunter | Biotech Hunter