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Trial · Interventional

CompletedPhase 4Registry data

The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes

Short name T2DM

NCTNCT00950677 (opens ClinicalTrials.gov in a new tab)Other idH-22439Other idK23DK075931

Overview

Status
Completed
Phase
Phase 4
Enrollment
16 participants (actual)
Sponsor
Baylor College of Medicine · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
Jul 2009
Primary completion
May 2011
Completion
May 2011
First posted
3 Aug 2009 (estimated)
Last update posted
24 Apr 2017
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 4

    T2DM

    NCT00950677

    Jul 2009 to May 2011

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 study drugs before a meal may lower blood sugars after the meal. An improvement in blood sugar control may prevent long-term problems of diabetes.

Interventions

  • Byetta (exenatide)Drug
  • Symlin (pramlintide)Drug

Arms2

  • Active comparator

    exenatide

    exenatide one dose

  • Active comparator

    pramlintide

    pramlintide one dose

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glucose

    Time frame · 4 hours

    Registry description

    concentration and AUC calculations

Secondary outcomes(4)
  1. glucagon

    Time frame · 4 hrours

    Registry description

    concentration and AUC calculations

  2. gastric emptying

    Time frame · 4 hours

    Registry description

    concentration and AUC calculations

  3. pramlintide concentrations

    Time frame · 4 hours

    Registry description

    concentration and AUC calculations

  4. exenatide concentrations

    Time frame · 4 hours

    Registry description

    concentration and AUC calculations

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Children with Type 2 Diabetes, * Between the ages of 12-21 years, * Tanner stage 4-5 for pubertal development, * Menstruating females must have a negative urine pregnancy test for inclusion, * Must have T2DM for at least 6 months, * History of negative anti-glutamic acid decarboxylase (GAD) -65 and anti-islet cell antibodies, * HbA1c \< 8.5% and on a stable dose of an oral hypoglycemic agent (with or without insulin) over the last 2 months, or well controlled on diet. Exclusion Criteria: * A history of a chronic disease other than diabetes (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, dyslipidemia, cholelithiasis etc), * BMI\> 40 kg/m2, * Weight of \< 60 kg, * Female with menstrual irregularities, * Allergy to local anesthetics (ELAMAX Cream, Ethyl Chloride), * Evidence or history of chemical abuse, * Anemia (age specific normal range for hemoglobin will be used), * Elevated liver enzymes (defined as more than 3 times the upper limit of the normal range for age), * Elevated BUN or creatinine (defined as more than 3 times the upper limit of the normal range for age), * Use of medications that may increase the blood sugars and admission to the hospital for diabetes related problems over the last 6 months.

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