DiabetesPhase 3NCT00071448
Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population
A Phase 3 study testing insulin human, insulin lispro and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 76 sites in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- insulin human, insulin lispro and insulin aspart
- How many people
- 378 participants
- Where
- 76 sitesUnited States
- Study dates
- Jun 2002to Jun 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patients with Type 1 diabetes for at least one year
- HbA1c less than 12%
- Willing to administer at least 3 injections per day
- Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary
Who cannot join
None listed.
Trial locations and contacts
76 sites in 1 country.
76 sites in 1 country
United States76 sites
Novo Nordisk Investigational Site
Akron, Ohio, 44308-1062
Novo Nordisk Investigational Site
Albany, New York, 12208
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87102
Novo Nordisk Investigational Site
Ann Arbor, Michigan, 48109
Novo Nordisk Investigational Site
Atlanta, Georgia, 30342
Novo Nordisk Investigational Site
Baltimore, Maryland, 21201
Novo Nordisk Investigational Site
Baltimore, Maryland, 21229
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, 70808
Novo Nordisk Investigational Site
Birmingham, Alabama, 35294
Novo Nordisk Investigational Site
Boston, Massachusetts, 02115
Novo Nordisk Investigational Site
Boston, Massachusetts, 02215
Novo Nordisk Investigational Site
Brooklyn, New York, 11219
Novo Nordisk Investigational Site
Buffalo, New York, 53226
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27599-7220
Novo Nordisk Investigational Site
Charleston, South Carolina, 29425
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195
Novo Nordisk Investigational Site
Columbia, South Carolina, 29203
Novo Nordisk Investigational Site
Columbus, Ohio, 43231
Novo Nordisk Investigational Site
Corpus Christi, Texas, 78411
Novo Nordisk Investigational Site
Dallas, Texas, 75235
Novo Nordisk Investigational Site
Danville, Pennsylvania, 17822
Novo Nordisk Investigational Site
Dayton, Ohio, 45404
Novo Nordisk Investigational Site
Englewood, Colorado, 80110
Novo Nordisk Investigational Site
Erie, Pennsylvania, 16507
Novo Nordisk Investigational Site
Gainesville, Florida, 32605
Novo Nordisk Investigational Site
Gainesville, Florida, 32608
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Hackensack, New Jersey, 07601
Novo Nordisk Investigational Site
Hartford, Connecticut, 06106
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46202-2879
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46250
Novo Nordisk Investigational Site
Iowa City, Iowa, 52242
Novo Nordisk Investigational Site
Kansas City, Missouri, 64108
Novo Nordisk Investigational Site
Lackland City, Texas, 78236
Novo Nordisk Investigational Site
Loma Linda, California, 92354
Novo Nordisk Investigational Site
Long Beach, California, 90806
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Novo Nordisk Investigational Site
Madison, Wisconsin, 53792
Novo Nordisk Investigational Site
Memphis, Tennessee, 38103
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Mineola, New York, 11501
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Mobile, Alabama, 36617
Novo Nordisk Investigational Site
Morgantown, West Virginia, 26506
Novo Nordisk Investigational Site
Morristown, New Jersey, 07962
Novo Nordisk Investigational Site
New Haven, Connecticut, 06520
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70127-5430
Novo Nordisk Investigational Site
New York, New York, 10022
Novo Nordisk Investigational Site
New York, New York, 10029
Novo Nordisk Investigational Site
Norfolk, Virginia, 23510
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Omaha, Nebraska, 68198-3020
Novo Nordisk Investigational Site
Orlando, Florida, 32806-1101
Novo Nordisk Investigational Site
Paterson, New Jersey, 07503
Novo Nordisk Investigational Site
Pensacola, Florida, 32504
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Phoenix, Arizona, 85013
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15213-3417
Novo Nordisk Investigational Site
Portland, Oregon, 97227
Novo Nordisk Investigational Site
Rochester, Minnesota, 55905
Novo Nordisk Investigational Site
Rochester, New York, 14642
Novo Nordisk Investigational Site
Sacramento, California, 95817
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84132
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Antonio, Texas, 78284
Novo Nordisk Investigational Site
San Diego, California, 92093
Novo Nordisk Investigational Site
San Diego, California, 92123
Novo Nordisk Investigational Site
Spokane, Washington, 99201
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308
Novo Nordisk Investigational Site
Tampa, Florida, 33612
Novo Nordisk Investigational Site
Temple, Texas, 76508
Novo Nordisk Investigational Site
Tucson, Arizona, 85712
Novo Nordisk Investigational Site
Worcester, Massachusetts, 01655
About this study
Official title: Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabetes
This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- insulin human, insulin lispro, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin humanDrug
insulin lisproDrug
insulin aspartDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (glycosylated haemoglobin A1c)
Secondary outcomes (1)
FPG (fasting plasma glucose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2003 (estimated)
- Study startJun 2002
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071448
- Sponsor's protocol ID
- ANA-2126
- Status last verified
- Dec 2016
- First submitted
- 23 Oct 2003
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Arslanian S, Foster C, Wright N, Stender S, Hu P, Hale P, Hale D. Comparison of Insulin Aspart, Regular Insulin, and Insulin Lispro in Basal Bolus Therapy with NPH To Treat Pediatric Patients with Type 1 Diabetes Mellitus. Diabetes 2005; 54 ((suppl 1)): A517 [Abstract 2150-PO]
Arslanian S, Foster C, Wright NM, Stender S, Hale P, Hale D. Insulin apart compared to regular insulin and insulin lispro in basal bolus therapy with NPH to treat pediatric patients with type 1 diabetes mellitus. EASD 2005 2005; 48(Suppl. 1): A327
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal/Bolus Therapy With Insulin Aspart (NovoLog®) Versus Regular Human Insulin (Novolin® R) or Insulin Lispro (Humalog®) in Combination With NPH: An Open-Label, Randomized, Parallel Group, Multicenter Study in Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00071448
- Acronym / sponsor ID
- ANA-2126
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 24 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in the United States of America (USA). The aim of this trial is to to determine whether insulin aspart can be used effectively and safely in paediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients with Type 1 diabetes for at least one year
- HbA1c less than 12%
- Willing to administer at least 3 injections per day
- Willing to perform self monitored blood glucose (SMBG) at least 4 times per day, includes subject and/or parent/guardian, as necessary
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin human | Drug | – |
| insulin lispro | Drug | – |
| insulin aspart | Drug | – |
Primary outcome
HbA1c (glycosylated haemoglobin A1c)
1 secondary outcome
FPG (fasting plasma glucose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Results publicationArslanian S, Foster C, Wright N, Stender S, Hu P, Hale P, Hale D. Comparison of Insulin Aspart, Regular Insulin, and Insulin Lispro in Basal Bolus Therapy with NPH To Treat Pediatric Patients with Type 1 Diabetes Mellitus. Diabetes 2005; 54 ((suppl 1)): A517 [Abstract 2150-PO]
- Results publicationArslanian S, Foster C, Wright NM, Stender S, Hale P, Hale D. Insulin apart compared to regular insulin and insulin lispro in basal bolus therapy with NPH to treat pediatric patients with type 1 diabetes mellitus. EASD 2005 2005; 48(Suppl. 1): A327
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin human, insulin lispro and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 76 sites in United States.
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 4 inclusion and 0 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 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HbA1c (glycosylated haemoglobin A1c). 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 NCT00071448, which also lists 2 linked publications.
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 22 Dec 2016.