AzTrials
AzTrials

Type 1 DiabetesPhase 4NCT00291772

Continuous Subcutaneous Infusion of Pramlintide and Insulin

A Phase 4 study testing Pramlintide in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 22 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Pramlintide
Type of treatment
Injection or infusion
How many people
13 participants
Where
1 siteUnited States
Study dates
Jan 2006to Nov 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 22 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be
  • 13-22 years of age at the time of enrollment.
  • Have been diagnosed with diabetes for at least 1 year and in good control (HbA1C less than or equal to 8.5%).
  • Be on continuous subcutaneous insulin infusion using an insulin pump.
  • Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.
  • Menstruating women must have a negative pregnancy test.
  • Hemoglobin equal to or greater than 12 g/dL before each study.
  • Weight more than 44 kg. -

Who cannot join

  • Age greater than 23 years or less than 13 years at the time of study
  • 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
  • Anemia (hemoglobin less than 12mg/dl)
  • Lack of a supportive family environment
  • Positive pregnancy test in menstruating young women
  • Evidence or history of chemical abuse
Show all 9Show fewer
  • Hgb A1C greater than 8.5 % in a diabetic subject
  • BMI > 90 % tile for age or < 10 % tile for age
  • Weight less than 44 kg. -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Children's Hospital

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Continuous Subcutaneous Infusion of Pramlintide and Insulin: A Randomized, Crossover Design Study

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.

Read the detailed description

The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar control for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of long-term health problems. Insulin management is aimed to control blood sugar as near to normal as safely possible. However, the possibility of low blood sugars still remains. Low blood sugars the major limiting factor in gaining "tight" control of blood sugar. Insulin (the hormone that lowers blood sugar) and glucagon (hormone that raises blood sugar) play a key role in keeping this careful balance. There is a lack of insulin and failure of glucagon to work correctly in diabetes. This leads to high blood sugars right after a meal.

It is very difficult to have normal blood sugars when someone has diabetes. This may be due to another hormone called amylin. This hormone may be too low in people with Type 1 diabetes. Amylin is made in the pancreas (the part of the body that makes insulin). Amylin works by lowering blood sugars after a meal. Pramlintide is the name of the study drug. It is the man-made form of amylin. It is given as a shot (under the skin) like insulin. Pramlintide has been FDA approved.

Studies in adults have shown that amylin lowers the high levels of glucagon made after a meal. This results in improved "after meal" high blood sugars and overall blood sugar control. Currently, the drug is given as a separate shot from insulin. When given as a shot (one dose shot given all at once) to children and young adults, it seems to cause low blood sugars right after a meal. The "slowing down" of food digestion may be the cause of the low blood sugars with pramlintide use. Another possible cause of the low blood sugars may be the way drug is being given (instant shot versus a slow infusion through a pump).

Conditions
Type 1 Diabetes
Being tested
Pramlintide
Keywords
Type 1 Diabetes, hypoglycemia, hyperglycemia
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PramlintideDrug

    Also called Symlin

    Basal and bolus pramlintide subcutaneous infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve for glucose

    Measured: 4 hrs

Secondary outcomes (1)

  1. glucagon and gastric emptying

    Measured: 4 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291772
Sponsor's protocol ID
H-17339
Status last verified
Jul 2016
First submitted
13 Feb 2006
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005 Apr;54(4):1100-7. doi: 10.2337/diabetes.54.4.1100.

    PubMed 15793249

  • Heptulla RA, Rodriguez LM, Mason KJ, Haymond MW. Twenty-four-hour simultaneous subcutaneous Basal-bolus administration of insulin and amylin in adolescents with type 1 diabetes decreases postprandial hyperglycemia. J Clin Endocrinol Metab. 2009 May;94(5):1608-11. doi: 10.1210/jc.2008-2580. Epub 2009 Feb 3.

    PubMed 19190104

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pramlintide in people with Type 1 Diabetes, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve for glucose (time frame: 4 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00291772, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in