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Trial · Interventional

CompletedPhase 4Registry data

Continuous Subcutaneous Infusion of Pramlintide and Insulin

Overview

Status
Completed
Phase
Phase 4
Enrollment
13 participants (actual)
Sponsor
Baylor College of Medicine · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2006
Primary completion
Nov 2007
Completion
Nov 2007
First posted
15 Feb 2006 (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
200620072008
  1. Ph 4

    Continuous Subcutaneous Infusion of Pramlintide and Insulin

    NCT00291772

    Jan 2006 to Nov 2007

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 the study drug in a slow and steady dose will lower blood sugars during the meal and after-meal time.

Interventions

  • PramlintideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Area under the curve for glucose

    Time frame · 4 hrs

Secondary outcomes(1)
  1. glucagon and gastric emptying

    Time frame · 4 hrs

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2009

4 results

Twenty-four-hour simultaneous subcutaneous Basal-bolus administration of insulin and amylin in adolescents with type 1 diabetes decreases postprandial hyperglycemia.

Heptulla et al. 2009The Journal of clinical endocrinology and metabolismcited by 18

PMID 19190104PMC2684475DOI 10.1210/jc.2008-2580PUB-19190104

Rights unknown4 results

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

Eligibility

Who could join, as posted.

Sex
All
Age
from 13 Years up to 22 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be 1. 13-22 years of age at the time of enrollment. 2. Have been diagnosed with diabetes for at least 1 year and in good control (HbA1C less than or equal to 8.5%). 3. Be on continuous subcutaneous insulin infusion using an insulin pump. 4. Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism. 5. Menstruating women must have a negative pregnancy test. 6. Hemoglobin equal to or greater than 12 g/dL before each study. 7. Weight more than 44 kg. - Exclusion Criteria: 1. Age greater than 23 years or less than 13 years at the time of study 2. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism stable on medications 3. Anemia (hemoglobin less than 12mg/dl) 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 greater than 8.5 % in a diabetic subject 8. BMI \> 90 % tile for age or \< 10 % tile for age 9. Weight less than 44 kg. -

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