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Type 1 Diabetes MellitusPhase 3PRESCHOOLNCT00993473

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

A Phase 3 study testing Insulin glargine (HOE901), Neutral Protamine Hagedorn (NPH) insulin and Insulin lispro in people with Type 1 Diabetes Mellitus, run by Sanofi at 61 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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)… Read more about this study

Who is it for?
Ages 1 year to 6 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Insulin glargine (HOE901), Neutral Protamine Hagedorn (NPH) insulin and Insulin lispro
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
61 sitesin 16 countries
Study dates
Oct 2009to Mar 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

61 sites in 16 countries.

61 sites in 16 countries

United States8 sites

  • Sanofi-Aventis Investigational Site Number 840008

    Baltimore, Maryland, 21229

  • Sanofi-Aventis Investigational Site Number 840007

    Buffalo, New York, 14222

  • Sanofi-Aventis Investigational Site Number 840005

    Greenwood Village, Colorado, 80111

  • Sanofi-Aventis Investigational Site Number 840010

    Houston, Texas, 77030

  • Sanofi-Aventis Investigational Site Number 840011

    Philadelphia, Pennsylvania, 19104

  • Sanofi-Aventis Investigational Site Number 840006

    Sacramento, California, 95819

  • Sanofi-Aventis Investigational Site Number 840002

    San Antonio, Texas, 78229

  • Sanofi-Aventis Investigational Site Number 840014

    San Diego, California, 92123

Other trials in United States

Brazil6 sites

  • Sanofi-Aventis Investigational Site Number 076001

    Brasília, 71625-009

  • Sanofi-Aventis Investigational Site Number 076003

    Curitiba, 80810-040

  • Sanofi-Aventis Investigational Site Number 076005

    Fortaleza, 60135-170

  • Sanofi-Aventis Investigational Site Number 076004

    Fortaleza, 60430-370

  • Sanofi-Aventis Investigational Site Number 076002

    Porto Alegre, 91350-250

  • Sanofi-Aventis Investigational Site Number 076006

    Rio de Janeiro, 20211-340

Other trials in Brazil

Hungary5 sites

  • Sanofi-Aventis Investigational Site Number 348004

    Budapest, 1023

  • Sanofi-Aventis Investigational Site Number 348005

    Budapest, 1089

  • Sanofi-Aventis Investigational Site Number 348003

    Miskolc, 3526

  • Sanofi-Aventis Investigational Site Number 348002

    Szeged, 6701

  • Sanofi-Aventis Investigational Site Number 348001

    Szombathely, 9700

Other trials in Hungary

India5 sites

  • Sanofi-Aventis Investigational Site Number 356003

    Bangalore, 560043

  • Sanofi-Aventis Investigational Site Number 356005

    Bangalore, 560052

  • Sanofi-Aventis Investigational Site Number 356001

    Bangalore

  • Sanofi-Aventis Investigational Site Number 356002

    Indore, 452001

  • Sanofi-Aventis Investigational Site Number 356004

    Karnāl, 132001

Other trials in India

Russia5 sites

  • Sanofi-Aventis Investigational Site Number 643001

    Moscow, 117036

  • Sanofi-Aventis Investigational Site Number 643002

    Moscow, 119049

  • Sanofi-Aventis Investigational Site Number 643003

    Saint Petersburg, 193144

  • Sanofi-Aventis Investigational Site Number 643004

    Ufa, 450000

  • Sanofi-Aventis Investigational Site Number 643005

    Yaroslavl, 150042

Other trials in Russia

Chile4 sites

  • Sanofi-Aventis Investigational Site Number 152002

    Santiago, 7830489

  • Sanofi-Aventis Investigational Site Number 152003

    Santiago, 8207257

  • Sanofi-Aventis Investigational Site Number 152001

    Santiago, 8910095

  • Sanofi-Aventis Investigational Site Number 152004

    Viña del Mar, 257-0017

Other trials in Chile

Romania4 sites

  • Sanofi-Aventis Investigational Site Number 642008

    Bucharest, 041451

  • Sanofi-Aventis Investigational Site Number 642001

    Cluj-Napoca, 400370

  • Sanofi-Aventis Investigational Site Number 642011

    Constanța, 900591

  • Sanofi-Aventis Investigational Site Number 642006

    Sibiu, 550166

Other trials in Romania

South Africa4 sites

  • Sanofi-Aventis Investigational Site Number 710004

    Durban

  • Sanofi-Aventis Investigational Site Number 710002

    Johannesburg, 2193

  • Sanofi-Aventis Investigational Site Number 710001

    Observatory, 7925

  • Sanofi-Aventis Investigational Site Number 710003

    Pretoria, 0084

Other trials in South Africa

Spain4 sites

  • Sanofi-Aventis Investigational Site Number 724003

    Santiago de Compostela, 15706

  • Sanofi-Aventis Investigational Site Number 724001

    Seville, 41013

  • Sanofi-Aventis Investigational Site Number 724005

    Valencia, 46010

  • Sanofi-Aventis Investigational Site Number 724004

    Zaragoza, 50009

Other trials in Spain

Czechia3 sites

  • Sanofi-Aventis Investigational Site Number 203001

    Olomouc, 77520

  • Sanofi-Aventis Investigational Site Number 203003

    Pardubice, 53203

  • Sanofi-Aventis Investigational Site Number 203002

    Ústí nad Labem, 40113

Other trials in Czechia

Mexico3 sites

  • Sanofi-Aventis Investigational Site Number 484002

    Guadalajara, 44620

  • Sanofi-Aventis Investigational Site Number 484003

    Monterrey, 64640

  • Sanofi-Aventis Investigational Site Number 484001

    Puebla City, 72190

Other trials in Mexico

Peru3 sites

  • Sanofi-Aventis Investigational Site Number 604003

    Lima, Lima 01

  • Sanofi-Aventis Investigational Site Number 604002

    Lima, Lima 5

  • Sanofi-Aventis Investigational Site Number 604001

    Lima

Other trials in Peru

Germany2 sites

  • Sanofi-Aventis Investigational Site Number 276002

    Düsseldorf, 40225

  • Sanofi-Aventis Investigational Site Number 276003

    Münster, 48155

Other trials in Germany

Poland2 sites

  • Sanofi-Aventis Investigational Site Number 616002

    Gdansk

  • Sanofi-Aventis Investigational Site Number 616001

    Warsaw, 04-730

Other trials in Poland

Turkey (Türkiye)2 sites

  • Sanofi-Aventis Investigational Site Number 792001

    Ankara, 06100

  • Sanofi-Aventis Investigational Site Number 792003

    Istanbul, 34000

Other trials in Turkey (Türkiye)

Austria1 site

  • Sanofi-Aventis Investigational Site Number 040001

    Vienna, 1090

Other trials in Austria

About this study

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

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
Read the 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

Being tested
Insulin glargine (HOE901), Neutral Protamine Hagedorn (NPH) insulin, Insulin lispro
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargine (HOE901)Drug

    Also called Lantus®

    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%.

  • Neutral Protamine Hagedorn (NPH) insulinDrug

    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

  • Insulin lisproDrug

    Also called Humalog®

    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.

Study groups in NCT00993473
Study groupRoleWhat they receive
Lantus (insulin glargine)ExperimentalLantus given as basal insulin once a day in the morning by subcutaneous injection
Receives: Drug: Insulin glargine (HOE901); Drug: Insulin lispro
NPH insulinActive comparatorNeutral 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
Receives: Drug: Neutral Protamine Hagedorn (NPH) insulin; Drug: Insulin lispro

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (9)

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. 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.

    Measured: 6 months

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

    Measured: baseline, 6 months

  7. 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.

    Measured: baseline, 6 months

  8. 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.

    Measured: 6 months

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

    Measured: baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00993473
Sponsor's protocol ID
EFC11202
Other IDs
2009-011231-12, 2009
Acronym
PRESCHOOL
Status last verified
Jun 2012
First submitted
9 Oct 2009
Last updated
27 Jun 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 25041275

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine (HOE901), Neutral Protamine Hagedorn (NPH) insulin and Insulin lispro in people with Type 1 Diabetes Mellitus, run by Sanofi at 61 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Brazil, Hungary, India, Russia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00993473, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2012.

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