Intranasal Insulin for Prevention of Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00223613 |
Recruitment Status
: Unknown
Verified August 2005 by University of Turku.
Recruitment status was: Recruiting
First Posted
: September 22, 2005
Last Update Posted
: September 19, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Drug: daily intranasal administration of insulin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | Intranasal Insulin for Prevention of Type 1 Diabetes in Children Carrying Increased HLA-Conferred Genetic Risk |
Study Start Date : | August 1997 |
Study Completion Date : | August 2005 |

- Development of clinical type 1 diabetes
- Number and concentration in serum of diabetes-associated autoantibodies (ICA, IAA, GADA and IA-2A)
- Responses to intravenous glucose tolerance test
- Possible side effects of therapy including hypoglycemia
- Changes in serum metabolite patterns (metabolomics)

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Ages Eligible for Study: | 1 Year to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- children carrying HLA-conferred genetic risk for developing type 1 diabetes
- have had at least two types of autoantibodies of ICA, IAA, GADA and IA-2A in at least two consecutive blood samples drawn at least 3 months apart
- age at least one year
Exclusion Criteria:
- severe other disease
- age above 15 years

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): NCT00223613
Contact: Olli G Simell, MD, PhD | +358-2-313-2466 | olli.simell@utu.fi | |
Contact: Tuula T Simell, MPH, PhD | +358-2-313-3427 | tuula.simell@utu.fi |
Finland | |
Department of Pediatrics, University of Turku | Recruiting |
Turku, Finland, FI-20520 | |
Contact: Tuula T Simell, MPH, PhD +358-2-313-3427 tuula.simell@utu.fi | |
Contact: Birgitta Nurmi, RN +358-2-313-2465 birgitta.nurmi@tyks.fi | |
Sub-Investigator: Kirsti Näntö-Salonen, MD, PhD |
Principal Investigator: | Olli G Simell, MD, PhD | University of Turku, Turku, Finland |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00223613 History of Changes |
Other Study ID Numbers: |
DIPP19942014 JDRF File # 4-1999-731 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | September 19, 2006 |
Last Verified: | August 2005 |
Keywords provided by University of Turku:
diabetes juvenile diabetes insulin deficiency |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |