NCT00993473 - 6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes | Biotech Hunter

Enrollment

125

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions

Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin glargine (HOE901)

"100 U/mL commercial solution for injection available as both disposable pen devices Solostar® each containing 300 U and as 10 mL vials each containing 1000 U~Dose: titrated to achieve the following glycemic targets without hypoglycemia:~* Fasting blood glucose (BG) between 90 and 145 mg/dL (5.0 to 8.0 mmol/L), inclusive,~* Bedtime BG between 120 and 180 mg/dL (6.7 to10.0 mmol/L), inclusive,~* Nocturnal BG between 80 and 162 mg/dL (4.4 to 9.0 mmol/L), inclusive; and~* HbA1c \<7.5%."

DRUG

Neutral Protamine Hagedorn (NPH) insulin

"NPH insulin 100 U/mL commercial (Huminsulin Basal) solution for injection available as both disposable pen devices (Huminsulin Basal Pen) each containing 300 U and as 10 mL vials each containing 1000 U~Dose: titrated to achieve glycemic targets as described above for insulin glargine"

DRUG

Insulin lispro

Insulin lispro used as the principal bolus insulin; regular human insulin permitted. Administration: multiple injection before meals and/or at bedtime at the discretion of the Investigator.

Trial Locations (61)

1023

Sanofi-Aventis Investigational Site Number 348004, Budapest

1089

Sanofi-Aventis Investigational Site Number 348005, Budapest

1090

Sanofi-Aventis Investigational Site Number 040001, Vienna

2193

Sanofi-Aventis Investigational Site Number 710002, Johannesburg

3526

Sanofi-Aventis Investigational Site Number 348003, Miskolc

6701

Sanofi-Aventis Investigational Site Number 348002, Szeged

7925

Sanofi-Aventis Investigational Site Number 710001, Observatory

9700

Sanofi-Aventis Investigational Site Number 348001, Szombathely

14222

Sanofi-Aventis Investigational Site Number 840007, Buffalo

15706

Sanofi-Aventis Investigational Site Number 724003, Santiago de Compostela

19104

Sanofi-Aventis Investigational Site Number 840011, Philadelphia

21229

Sanofi-Aventis Investigational Site Number 840008, Baltimore

34000

Sanofi-Aventis Investigational Site Number 792003, Istanbul

40113

Sanofi-Aventis Investigational Site Number 203002, Ústí nad Labem

40225

Sanofi-Aventis Investigational Site Number 276002, Düsseldorf

41013

Sanofi-Aventis Investigational Site Number 724001, Seville

44620

Sanofi-Aventis Investigational Site Number 484002, Guadalajara

46010

Sanofi-Aventis Investigational Site Number 724005, Valencia

48155

Sanofi-Aventis Investigational Site Number 276003, Münster

50009

Sanofi-Aventis Investigational Site Number 724004, Zaragoza

53203

Sanofi-Aventis Investigational Site Number 203003, Pardubice

64640

Sanofi-Aventis Investigational Site Number 484003, Monterrey

72190

Sanofi-Aventis Investigational Site Number 484001, Puebla City

77030

Sanofi-Aventis Investigational Site Number 840010, Houston

77520

Sanofi-Aventis Investigational Site Number 203001, Olomouc

78229

Sanofi-Aventis Investigational Site Number 840002, San Antonio

80111

Sanofi-Aventis Investigational Site Number 840005, Greenwood Village

92123

Sanofi-Aventis Investigational Site Number 840014, San Diego

95819

Sanofi-Aventis Investigational Site Number 840006, Sacramento

117036

Sanofi-Aventis Investigational Site Number 643001, Moscow

119049

Sanofi-Aventis Investigational Site Number 643002, Moscow

132001

Sanofi-Aventis Investigational Site Number 356004, Karnāl

150042

Sanofi-Aventis Investigational Site Number 643005, Yaroslavl

193144

Sanofi-Aventis Investigational Site Number 643003, Saint Petersburg

400370

Sanofi-Aventis Investigational Site Number 642001, Cluj-Napoca

450000

Sanofi-Aventis Investigational Site Number 643004, Ufa

452001

Sanofi-Aventis Investigational Site Number 356002, Indore

550166

Sanofi-Aventis Investigational Site Number 642006, Sibiu

560043

Sanofi-Aventis Investigational Site Number 356003, Bangalore

560052

Sanofi-Aventis Investigational Site Number 356005, Bangalore

900591

Sanofi-Aventis Investigational Site Number 642011, Constanța

7830489

Sanofi-Aventis Investigational Site Number 152002, Santiago

8207257

Sanofi-Aventis Investigational Site Number 152003, Santiago

8910095

Sanofi-Aventis Investigational Site Number 152001, Santiago

71625-009

Sanofi-Aventis Investigational Site Number 076001, Brasília

80810-040

Sanofi-Aventis Investigational Site Number 076003, Curitiba

60135-170

Sanofi-Aventis Investigational Site Number 076005, Fortaleza

60430-370

Sanofi-Aventis Investigational Site Number 076004, Fortaleza

91350-250

Sanofi-Aventis Investigational Site Number 076002, Porto Alegre

20211-340

Sanofi-Aventis Investigational Site Number 076006, Rio de Janeiro

257-0017

Sanofi-Aventis Investigational Site Number 152004, Viña del Mar

Unknown

Sanofi-Aventis Investigational Site Number 356001, Bangalore

Sanofi-Aventis Investigational Site Number 604001, Lima

Sanofi-Aventis Investigational Site Number 616002, Gdansk

Sanofi-Aventis Investigational Site Number 710004, Durban

Lima 01

Sanofi-Aventis Investigational Site Number 604003, Lima

Lima 5

Sanofi-Aventis Investigational Site Number 604002, Lima

04-730

Sanofi-Aventis Investigational Site Number 616001, Warsaw

041451

Sanofi-Aventis Investigational Site Number 642008, Bucharest

0084

Sanofi-Aventis Investigational Site Number 710003, Pretoria

06100

Sanofi-Aventis Investigational Site Number 792001, Ankara