NCT01476475 - Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients | Biotech Hunter

Enrollment

323

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG

Insulin glargine /lixisenatide Fixed Ratio Combination

FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using pen-type injector (Tactipen®): 100 U/ml insulin glargine and 50 mcg Lixisenatide (ratio of 2 U/1 mcg). The initial dose was 10 U/5 mcg and then dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L.

DRUG

Insulin glargine

Insulin glargine (100 U/ml) was self-administered by SC injection before breakfast using pen-type injector (Lantus® Solostar®). The initial daily dose of insulin glargine was 10 U and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).

DRUG

Metformin (Background drug)

Pharmaceutical form: Tablet; Route of administration: oral administration. To be kept at stable dose (≥1.5 g/day) throughout the study.

Trial Locations (70)

1041

Investigational Site Number 348405, Budapest

1212

Investigational Site Number 348406, Budapest

2400

Investigational Site Number 208401, København NV

4043

Investigational Site Number 348404, Debrecen

4200

Investigational Site Number 208402, Slagelse

4600

Investigational Site Number 208404, Køge

5700

Investigational Site Number 208403, Svendborg

6720

Investigational Site Number 348402, Szeged

6722

Investigational Site Number 348403, Szeged

8230

Investigational Site Number 348401, Balatonfüred

11018

Investigational Site Number 250402, Narbonne

12808

Investigational Site Number 203402, Prague

14224

Investigational Site Number 840415, West Seneca

18100

Investigational Site Number 203405, Prague

20782

Investigational Site Number 840404, Hyattsville

20852

Investigational Site Number 840405, Rockville

27713

Investigational Site Number 840413, Durham

30045

Investigational Site Number 840401, Larenceville

30076

Investigational Site Number 840417, Roswell

32600

Investigational Site Number 203401, Pilsen

34270

Investigational Site Number 484405, Durango

39670

Investigational Site Number 484404, Acapulco

40504

Investigational Site Number 840403, Lexington

44210

Investigational Site Number 484402, Guadalajara

44656

Investigational Site Number 484403, Guadalajara

46045

Investigational Site Number 276403, Oberhausen

54511

Investigational Site Number 250401, Vandœuvre-lès-Nancy

62250

Investigational Site Number 484401, Cuernavaca

67059

Investigational Site Number 276402, Ludwigshafen

72205

Investigational Site Number 840408, Little Rock

73069

Investigational Site Number 840402, Norman

74101

Investigational Site Number 203403, Nový Jičín

75230

Investigational Site Number 840410, Dallas

85101

Investigational Site Number 703402, Bratislava

86021

Investigational Site Number 250404, Poitiers

89148

Investigational Site Number 840411, Las Vegas

90723

Investigational Site Number 840412, Paramount

94911

Investigational Site Number 703405, Nitra

97504

Investigational Site Number 840407, Medford

98055

Investigational Site Number 840414, Renton

300133

Investigational Site Number 642404, Timișoara

410169

Investigational Site Number 642401, Oradea

500365

Investigational Site Number 642402, Brasov

540142

Investigational Site Number 642406, Târgu Mureş

700547

Investigational Site Number 642405, Iași

7500347

Investigational Site Number 152404, Santiago

Investigational Site Number 152405, Santiago

7500710

Investigational Site Number 152403, Santiago

7980378

Investigational Site Number 152401, Santiago

8320000

Investigational Site Number 152402, Santiago

01307

Investigational Site Number 276401, Dresden

LT-49456

Investigational Site Number 440401, Kaunas

LT-51270

Investigational Site Number 440402, Kaunas

LT-57164

Investigational Site Number 440403, Kėdainiai

LT-92304

Investigational Site Number 440404, Klaipėda

15-435

Investigational Site Number 616405, Bialystok

80-847

Investigational Site Number 616406, Gdansk

31-548

Investigational Site Number 616403, Krakow

94-074

Investigational Site Number 616407, Lodz

24-100

Investigational Site Number 616404, Puławy

70-506

Investigational Site Number 616402, Szczecin

02-507

Investigational Site Number 616401, Warsaw

020475

Investigational Site Number 642403, Bucharest

04001

Investigational Site Number 703403, Košice

04013

Investigational Site Number 703406, Košice

04525

Investigational Site Number 703404, Moldava nad Bodvou

01001

Investigational Site Number 703401, Žilina

931 32

Investigational Site Number 752402, Skellefteå

171 76

Investigational Site Number 752401, Stockholm

351 85

Investigational Site Number 752403, Vaxjo