Insulin Aspart vs. Insulin Lispro vs. Regular Insulin in Paediatric Population
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00071448 |
Recruitment Status :
Completed
First Posted : October 24, 2003
Last Update Posted : December 22, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 1 | Drug: insulin human Drug: insulin lispro Drug: insulin aspart | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 378 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | June 2002 |
Actual Primary Completion Date : | June 2004 |
Actual Study Completion Date : | June 2004 |

- HbA1c (glycosylated haemoglobin A1c)
- FPG (fasting plasma glucose)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071448

Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00071448 |
Other Study ID Numbers: |
ANA-2126 |
First Posted: | October 24, 2003 Key Record Dates |
Last Update Posted: | December 22, 2016 |
Last Verified: | December 2016 |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin Insulin, Globin Zinc Insulin Aspart Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs |