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6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes (PRESCHOOL)

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Insulin glargine (HOE901)

Neutral Protamine Hagedorn (NPH) insulin

Insulin lispro

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study

Exclusion criteria:

Diagnosis of type 1 diabetes for less than one year
HbA1c at screening >12% or <6%
Diabetes other than type 1 diabetes
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
Patients treated with insulin pump therapy during the two months prior to screening
History of primary seizure disorder
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
Serum creatinine > 2.0mg/dL at screening
Serum ALT or AST greater than 3x upper limit of normal for the patient's age and gender, at screening
Hemoglobin < 10g/dL, or platelet count less than 100,000/cu mm, at screening
Treatment with any pharmacologic anti-hyperglycemic oral agent for more than 3 months at any time
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin®) for the 3 months prior to screening
Treatment with systemic glucocorticoids within the month prior to screening

Above information not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lantus (insulin glargine)

NPH insulin

Arm Description

Lantus given as basal insulin once a day in the morning by subcutaneous injection

Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day generally in the morning and /or at bedtime by subcutaneous injection

Outcomes

Primary Outcome Measures

Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)

The rate of "all hypoglycemia" was calculated from "all hypoglycemia" episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients' diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose <70 mg/dL [3.9 mmol/L]) confirmed by fingerstick blood glucose (FSBG) <70 mg/dL, - low FSBG readings (values <70 mg/dL) performed at other times.

Secondary Outcome Measures

Event Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)

Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries.

Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Severe symptomatic hypoglycemia: any event with clinical symptoms considered to result from a hypoglycemic episode for which the patients required the assistance of a third party (ie, other than the patient, or a parent/usual caregiver; eg, from emergency personnel), because the patients/parents could not treat the event with acute neurological impairment directly resulting from the hypoglycemic event. The occurrence of seizure, coma, unconsciousness, or the use of glucagon, were also to qualify a hypoglycemic episode as severe.

Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of "All Hypoglycemia" Episodes Divided by the Total Duration of the On-treatment Period in Years

Nocturnal hypoglycemia: any event from the "all hypoglycemia" total that occurred between 23:00 and 07:00 hours.

Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.

Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.

Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment

Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)

Assessed using an analysis of covariance (ANCOVA) model with treatment, and randomization strata (baseline number of CGM hypoglycemic excursions <0.5 events/24hours or ≥0.5 events/24 hours, and baseline HbA1c <8.5% or ≥8.5%) as fixed effects, and using the baseline value as covariate.

Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit

Percentage of patients reaching International Society for Pediatric and Adolescent Diabetes (ISPAD)-recommended goals of Glycosylated Hemoglobin A1c <7.5% at the end of treatment visit.

Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment

Full Information

NCT ID

NCT00993473

First Posted

October 9, 2009

Last Updated

June 25, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00993473

Brief Title

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

Acronym

PRESCHOOL

Official Title

A 24-week, Randomized, Open-label, Parallel Group Multinational Comparison of Lantus® (Insulin Glargine) Given in the Morning as Once-a-day Basal Insulin Versus Neutral Protamine Hagedorn (NPH) Insulin, in Children With Type 1 Diabetes Mellitus Aged at Least 1 Year to Less Than 6 Years

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) between children treated with Lantus (insulin glargine) and Neutral Protamine Hagedorn (NPH) insulin. Secondary objectives were to compare insulin glargine and NPH in terms of: rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal symptomatic, and severe nocturnal symptomatic hypoglycemia HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment average blood glucose over whole trial and at end of trial, as estimated by continuous glucose monitoring (CGM), and blood glucose variability

Detailed Description

Screening phase: 2 to 4 weeks Treatment phase: 24 weeks At randomization, patients were stratified with respect to their baseline HbA1c level (<8.5% or ≥8.5%) and hypoglycemic event rate (number of CGMS hypoglycemic excursions <0.5 or ≥0.5 events per 24 hours). Following randomization, trial basal insulin was initiated and up-titrated within the first 12 weeks to reach a stable dose. Follow-up phase: 2 weeks All Phases: 28 to 30 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lantus (insulin glargine)

Arm Type

Experimental

Arm Description

Lantus given as basal insulin once a day in the morning by subcutaneous injection

Arm Title

NPH insulin

Arm Type

Active Comparator

Arm Description

Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day generally in the morning and /or at bedtime by subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Insulin glargine (HOE901)

Other Intervention Name(s)

Lantus®

Intervention Description

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%.

Intervention Type

Drug

Intervention Name(s)

Neutral Protamine Hagedorn (NPH) insulin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Insulin lispro

Other Intervention Name(s)

Humalog®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Description

Symptomatic hypoglycemia: any event with clinical symptoms considered to result from hypoglycemia, validated by the study investigator based on data from patient diaries.

Time Frame

6 months

Title

Event Rate of Severe Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Description

Time Frame

6 months

Title

Event Rate of Nocturnal Hypoglycemia Defined as the Total Number of "All Hypoglycemia" Episodes Divided by the Total Duration of the On-treatment Period in Years

Description

Nocturnal hypoglycemia: any event from the "all hypoglycemia" total that occurred between 23:00 and 07:00 hours.

Time Frame

6 months

Title

Event Rate of Nocturnal Symptomatic Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Description

Nocturnal symptomatic hypoglycemia: any symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.

Time Frame

6 months

Title

Event Rate of Severe Nocturnal Hypoglycemia Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years

Description

Severe nocturnal symptomatic hypoglycemia: any severe symptomatic hypoglycemic event that occurred between 23:00 and 07:00 hours.

Time Frame

6 months

Title

Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment

Time Frame

baseline, 6 months

Title

Glycosylated Hemoglobin A1c (HbA1c): End of Treatment and Change From Baseline to End of Treatment (ANCOVA Estimates)

Description

Time Frame

baseline, 6 months

Title

Percentage of Patients Reaching HbA1c Target of Less Than 7.5% at the End of Treatment Visit

Description

Percentage of patients reaching International Society for Pediatric and Adolescent Diabetes (ISPAD)-recommended goals of Glycosylated Hemoglobin A1c <7.5% at the end of treatment visit.

Time Frame

6 months

Title

Average Daily Blood Glucose (BG) Based on CGMS Values: End of Treatment and Change From Baseline to End of Treatment

Time Frame

baseline, 6 months

Other Pre-specified Outcome Measures:

Title

Number of Patients With Different Types of Hypoglycemia Events

Description

Definitions of the different types of hypoglycemia events provided in the outcome measure description of the corresponding event rates.

Time Frame

6 months

Title

Percent of Blood Glucose (BG) Within the Range of 70 - 180 mg/dL (3.9-10 mmol/L)

Description

Calculated for each patient as the percent of all on-treatment CGMS values falling within the range of 70 - 180 mg/dL (3.9 - 10 mmol/L) inclusive.

Time Frame

6 months

Title

Blood Glucose Variability Based on All On-treatment CGMS Values

Description

Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded over all CGMS placements.

Time Frame

6 months

Title

Nocturnal Blood Glucose Variability Based on All On-treatment CGMS Values

Description

Calculated for any given patient as the standard deviation (SD) of all CGMS interstitial glucose values recorded during the nocturnal time period (between 23:00 and 07:00 hours).

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study Exclusion criteria: Diagnosis of type 1 diabetes for less than one year HbA1c at screening >12% or <6% Diabetes other than type 1 diabetes Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person) Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit Patients treated with insulin pump therapy during the two months prior to screening History of primary seizure disorder History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit Need for chronic treatment with acetaminophen (paracetamol)-containing medications Serum creatinine > 2.0mg/dL at screening Serum ALT or AST greater than 3x upper limit of normal for the patient's age and gender, at screening Hemoglobin < 10g/dL, or platelet count less than 100,000/cu mm, at screening Treatment with any pharmacologic anti-hyperglycemic oral agent for more than 3 months at any time Treatment with any non-insulin antihyperglycemic medication (eg, Symlin®) for the 3 months prior to screening Treatment with systemic glucocorticoids within the month prior to screening Above information not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Investigational Site Number 840006

City

Sacramento

State/Province

California

ZIP/Postal Code

95819

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840014

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840005

City

Greenwood Village

State/Province

Colorado

ZIP/Postal Code

80111

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840008

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840007

City

Buffalo

State/Province

New York

ZIP/Postal Code

14222

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840011

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840010

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 840002

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Sanofi-Aventis Investigational Site Number 040001

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Sanofi-Aventis Investigational Site Number 076001

City

Brasilia

ZIP/Postal Code

71625-009

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076003

City

Curitiba

ZIP/Postal Code

80810-040

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076005

City

Fortaleza

ZIP/Postal Code

60135-170

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076004

City

Fortaleza

ZIP/Postal Code

60430-370

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076002

City

Porto Alegre

ZIP/Postal Code

91350-250

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 076006

City

Rio De Janeiro

ZIP/Postal Code

20211-340

Country

Brazil

Facility Name

Sanofi-Aventis Investigational Site Number 152002

City

Santiago

ZIP/Postal Code

7830489

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152003

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152001

City

Santiago

ZIP/Postal Code

8910095

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 152004

City

Viña Del Mar

ZIP/Postal Code

257-0017

Country

Chile

Facility Name

Sanofi-Aventis Investigational Site Number 203001

City

Olomouc

ZIP/Postal Code

77520

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 203003

City

Pardubice

ZIP/Postal Code

53203

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 203002

City

Usti Nad Labem

ZIP/Postal Code

40113

Country

Czech Republic

Facility Name

Sanofi-Aventis Investigational Site Number 276002

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 276003

City

Münster

ZIP/Postal Code

48155

Country

Germany

Facility Name

Sanofi-Aventis Investigational Site Number 348004

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Sanofi-Aventis Investigational Site Number 348005

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

Facility Name

Sanofi-Aventis Investigational Site Number 348003

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

Sanofi-Aventis Investigational Site Number 348002

City

Szeged

ZIP/Postal Code

6701

Country

Hungary

Facility Name

Sanofi-Aventis Investigational Site Number 348001

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Sanofi-Aventis Investigational Site Number 356003

City

Bangalore

ZIP/Postal Code

560043

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 356005

City

Bangalore

ZIP/Postal Code

560052

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 356001

City

Bangalore

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 356002

City

Indore

ZIP/Postal Code

452001

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 356004

City

Karnal

ZIP/Postal Code

132001

Country

India

Facility Name

Sanofi-Aventis Investigational Site Number 484002

City

Guadalajara

ZIP/Postal Code

44620

Country

Mexico

Facility Name

Sanofi-Aventis Investigational Site Number 484003

City

Monterrey

ZIP/Postal Code

64640

Country

Mexico

Facility Name

Sanofi-Aventis Investigational Site Number 484001

City

Puebla

ZIP/Postal Code

72190

Country

Mexico

Facility Name

Sanofi-Aventis Investigational Site Number 604003

City

Lima

ZIP/Postal Code

Lima 01

Country

Peru

Facility Name

Sanofi-Aventis Investigational Site Number 604002

City

Lima

ZIP/Postal Code

Lima 5

Country

Peru

Facility Name

Sanofi-Aventis Investigational Site Number 604001

City

Lima

Country

Peru

Facility Name

Sanofi-Aventis Investigational Site Number 616002

City

Gdansk

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 616001

City

Warszawa

ZIP/Postal Code

04-730

Country

Poland

Facility Name

Sanofi-Aventis Investigational Site Number 642008

City

Bucharest

ZIP/Postal Code

041451

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642001

City

Cluj Napoca

ZIP/Postal Code

400370

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642011

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 642006

City

Sibiu

ZIP/Postal Code

550166

Country

Romania

Facility Name

Sanofi-Aventis Investigational Site Number 643001

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643002

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643003

City

St-Petersburg

ZIP/Postal Code

193144

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643004

City

Ufa

ZIP/Postal Code

450000

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 643005

City

Yaroslavl

ZIP/Postal Code

150042

Country

Russian Federation

Facility Name

Sanofi-Aventis Investigational Site Number 710004

City

Durban

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710002

City

Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710001

City

Observatory

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 710003

City

Pretoria

ZIP/Postal Code

0084

Country

South Africa

Facility Name

Sanofi-Aventis Investigational Site Number 724003

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724001

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724005

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 724004

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Sanofi-Aventis Investigational Site Number 792001

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Sanofi-Aventis Investigational Site Number 792003

City

Istanbul

ZIP/Postal Code

34000

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

25041275

Citation

Danne T, Becker RH, Ping L, Philotheou A. Insulin glargine metabolite 21(A) -Gly-human insulin (M1) is the principal component circulating in the plasma of young children with type 1 diabetes: results from the PRESCHOOL study. Pediatr Diabetes. 2015 Jun;16(4):299-304. doi: 10.1111/pedi.12161. Epub 2014 Jul 9.

Results Reference

derived

Learn more about this trial

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

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6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes (PRESCHOOL)

Type 1 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial