NCT01798706 - Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients | Biotech Hunter

Enrollment

350

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions

Type 2 Diabetes

Interventions

DRUG

Lixisenatide (AVE0010)

"Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning~Route of administration: Subcutaneous injection"

DRUG

Placebo

"Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning~Route of administration: Subcutaneous injection"

DRUG

Antidiabetic background therapy

Participants received a stable regimen of anti-diabetic background therapy for at least 3 months prior to screening, during the placebo run-in period and the 24 week treatment period. Allowed background antidiabetic therapy included metformin, sulfonylurea (except glibenclamide \>10 mg, gliclazide \>160 mg), meglitinides (except repaglinide \>6 mg), pioglitazone and basal insulin. Insulin glargine, neutral protamine hagedorn (NPH) insulin, detemir, lente and ultralente were considered as basal insulin.

Trial Locations (83)

27

Investigational Site Number 604011, Lima

1632

Investigational Site Number 100003, Sofia

2050

Investigational Site Number 036004, Camperdown

2100

Investigational Site Number 036006, Brookvale

2212

Investigational Site Number 578005, Kongsvinger

2250

Investigational Site Number 036005, Gosford

2300

Investigational Site Number 208004, København S

2400

Investigational Site Number 208001, København NV

3050

Investigational Site Number 036003, Parkville

3081

Investigational Site Number 036001, Heidelberg

3128

Investigational Site Number 036002, Box Hill

3515

Investigational Site Number 578001, Hønefoss

4002

Investigational Site Number 100002, Plovdiv

Investigational Site Number 100005, Plovdiv

4095

Investigational Site Number 578006, Stavanger

4200

Investigational Site Number 208002, Slagelse

5700

Investigational Site Number 208003, Svendborg

6000

Investigational Site Number 100004, Stara Zagora

6700

Investigational Site Number 208005, Esbjerg

7012

Investigational Site Number 578004, Trondheim

7130

Investigational Site Number 710004, Somerset West

7500

Investigational Site Number 710003, Cape Town

7530

Investigational Site Number 710002, Cape Town

9000

Investigational Site Number 100001, Varna

11540

Investigational Site Number 724002, Sanlúcar de Barrameda

14469

Investigational Site Number 276008, Potsdam

15706

Investigational Site Number 724004, Santiago de Compostela

20745

Investigational Site Number 840008, Oxon Hill

20852

Investigational Site Number 840004, Rockville

22221

Investigational Site Number 752002, Lund

28046

Investigational Site Number 724003, Madrid

28144

Investigational Site Number 840016, Salisbury

33156

Investigational Site Number 840003, Miami

Investigational Site Number 840012, Miami

35415

Investigational Site Number 276007, Pohlheim

39531

Investigational Site Number 840017, Biloxi

44614

Investigational Site Number 840014, Canal Fulton

45359

Investigational Site Number 276004, Essen

46600

Investigational Site Number 724001, Alzira

48145

Investigational Site Number 276001, Münster

50314

Investigational Site Number 840002, Des Moines

53209

Investigational Site Number 840007, Milwaukee

58103

Investigational Site Number 840006, Fargo

66740

Investigational Site Number 276003, Saarlouis

68131

Investigational Site Number 840009, Omaha

80639

Investigational Site Number 276002, München

84790

Investigational Site Number 840011, St. George

90650

Investigational Site Number 840015, Norwalk

92037

Investigational Site Number 840010, La Jolla

L8L 5G8

Investigational Site Number 124003, Hamilton

N6B 2E3

Investigational Site Number 124007, London

G6W 5M6

Investigational Site Number 124001, Saint Romuald

J1H 5N4

Investigational Site Number 124002, Sherbrooke

V5Z 1M9

Investigational Site Number 124005, Vancouver

Investigational Site Number 124006, Vancouver

H3Z 1E5

Investigational Site Number 124008, Westmount

R3E 3P4

Investigational Site Number 124004, Winnipeg

01307

Investigational Site Number 276005, Dresden

01796

Investigational Site Number 276006, Pirna

Unknown

Investigational Site Number 578003, Oslo

Investigational Site Number 604001, Arequipa

Investigational Site Number 604002, Lima

Investigational Site Number 604007, Lima

Investigational Site Number 604008, Piura

Investigational Site Number 826001, Glasgow

LIMA 10

Investigational Site Number 604005, Lima

LIMA 14

Investigational Site Number 604003, Lima

LIMA 31

Investigational Site Number 604006, Lima

80-858

Investigational Site Number 616004, Gdansk

31-024

Investigational Site Number 616003, Krakow

61-665

Investigational Site Number 616001, Poznan

41-709

Investigational Site Number 616002, Ruda Śląska

70-506

Investigational Site Number 616006, Szczecin

08035

Investigational Site Number 724005, Barcelona

08550

Investigational Site Number 724006, Hostalets de Balenyà

405 45

Investigational Site Number 752006, Gothenburg

871 82

Investigational Site Number 752007, Härnösand

211 52

Investigational Site Number 752004, Malmo

111 57

Investigational Site Number 752003, Stockholm

171 76

Investigational Site Number 752001, Stockholm

TN39 4SP

Investigational Site Number 826003, Bexhill-on-Sea

KA12 0AY

Investigational Site Number 826002, Irvine

BA14 8QA

Investigational Site Number 826004, Trowbridge