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Trial · Interventional

CompletedPhase 3Registry data

The Role of Amylin and Glucagon in T1DM

NCTNCT00206258 (opens ClinicalTrials.gov in a new tab)Other idH-11741
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
30 participants
Sponsor
Baylor College of Medicine · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2002
Primary completion
Not stated
Completion
Aug 2005
First posted
21 Sept 2005 (estimated)
Last update posted
14 Jul 2016 (estimated)
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022003200420052006
  1. Ph 3

    The Role of Amylin and Glucagon in T1DM

    NCT00206258

    Jul 2002 to Aug 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to see if giving pramlintide and insulin before a meal would lower high blood sugar and if a glucagon (a naturally made hormone in the body but reduced in diabetes and its role is in prevention of low blood sugar) shot given in the late "after meal" time would prevent low blood sugar. The studies outlined in this proposal might help in developing new treatment options to target "after meal" high blood sugar and before meal low blood sugar in children. This would possibly help improve overall blood sugar control and prevent the long-term complications of diabetes.

Interventions

  • Pramlintide and glucagonDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the curve for glucose

Secondary outcomes(1)

  1. Glucagon and gastric emptying

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2005

2 results

The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes.

Heptulla et al. 2005Diabetescited by 61

PMID 15793249DOI 10.2337/diabetes.54.4.1100PUB-15793249

Full text at the publisher2 results
Publisher pageSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 21 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Age \>12 years \< 19 years 2. Have diabetes for at least 2 years and in good control (HbA1C \< 8%). 3. Be on continuous subcutaneous insulin infusion using an insulin pump. 4. Subjects must be otherwise healthy except for their T1DM and treated for hypothyroidism. 5. Menstruating women must have negative pregnancy test. 6. Hemoglobin equal to or \> than 12 g/dL before each study. 7. Weight more than 44 kg. Exclusion Criteria: 1. Age \>18 or \< 12 y at the time of study 2. Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis 3. Hemoglobin less than 12 g/dl (If before any of the studies the hemoglobin is lower than 12 g/dl, subjects will be excluded from further studies) 4. Lack of a supportive family environment 5. Positive pregnancy test in menstruating young women 6. Evidence or history of chemical abuse 7. Hgb A1c \>8.0 % in a diabetic subject 8. BMI \> 90 % tile for age or \< 10 % tile for age 9. Allergy to local anesthetics (ELAMAX Cream) 10. Weight less than 44 kg 11. Children of staff members

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