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CompletedNCT00950677T2DMUpdated Apr 24, 2017

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

A Phase 4 interventional study of Byetta (exenatide) and Symlin (pramlintide) in Type 2 Diabetes, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2017-04-24.

Sponsored by Baylor College of Medicine · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2011, 15 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
12 Years to 21 Years
Sex
All
01

Study summary

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.

Read the detailed description

A large study in people with type 2 diabetes (T2DM) showed that lowering blood sugars stopped or delayed the occurrence of health problems. As a result of the study, treatment should try to control blood sugars as near to normal as safely possible.

In people without diabetes, the "after meal" blood sugar level is very carefully controlled by several hormones. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. Also, we now know of 2 new substances made by the body called amylin and GLP-1 that also help with this careful balance. Amylin is made in the pancreas. GLP-1 is made in the gut. We know that both amylin and GLP-1 are abnormal in people with diabetes.

There are two medicines that may help to control after meal blood sugars from going too high. The medicines are called Symlin (pramlintide) and Byetta (exenatide). Symlin works like amylin. Byetta works like GLP-1. Both medications are very similar in the ways that they work to control blood sugars.

Both medicines help to keep glucagon lower after a meal. They both also help the stomach to digest food more slowly so the blood sugar does not go up too fast after eating. They also help to control how much hunger a person may have before meals. This may help a person to eat less and possibly lose weight. Byetta also seems to help islet cells (cells that make insulin) make more insulin.

Byetta and Symlin are FDA approved for use in adults with T2DM. We want to study these drugs in children with T2DM.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Diabetes
  • pramlintide
  • Symlin
  • exenatide
  • byetta
  • glucagon
  • gastric emptying
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 16 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 111 are open to participants now.

Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.

Browse Baylor College of Medicine studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    exenatide

    exenatide one dose

    Drug: Byetta (exenatide)

  • Active comparator
    pramlintide

    pramlintide one dose

    Drug: Symlin (pramlintide)

Interventions

06

What researchers measure

Primary outcomes

  1. Glucose

    concentration and AUC calculations

    Time frame: 4 hours

Secondary outcomes

  1. glucagon

    concentration and AUC calculations

    Time frame: 4 hrours

  2. gastric emptying

    concentration and AUC calculations

    Time frame: 4 hours

  3. pramlintide concentrations

    concentration and AUC calculations

    Time frame: 4 hours

  4. exenatide concentrations

    concentration and AUC calculations

    Time frame: 4 hours

07

Study locations

1 site
  • Baylor College of Medicine
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2009, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2009
First posted
Aug 3, 2009
Start
Jul 2009
Primary completionActual
May 2011
CompletionActual
May 2011
Last update
Apr 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00950677
Lead sponsor
Baylor College of Medicine
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Luisa M. Rodriguez (Principal Investigator, Baylor College of Medicine) — Principal investigator
First posted
Aug 3, 2009
Start date
Jul 2009
Primary completion
May 2011
Completion
May 2011
Last update
Apr 24, 2017

Study contacts

LUISA M RODRIGUEZ, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Exenatide · Pramlintide

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