Trial · Interventional

CompletedNot applicableResults postedRegistry data

Pramlintide in Adolescents With Type 1 Diabetes

NCTNCT00842075Other id05-0724(2)

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 10 participants (actual)
Sponsor: University of Colorado, Denver · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Dec 2006
Primary completion: Dec 2009
Completion: Dec 2009
First posted: 12 Feb 2009 (estimated)
Last update posted: 23 Jun 2015 (estimated)
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20062007200820092010

N/A
Pramlintide in Adolescents With Type 1 Diabetes
NCT00842075
Dec 2006 to Dec 2009

Registry summary

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

The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes. This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).

Interventions

pramlintideDrug

Arms2

Experimental
1 Symlin
Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
No intervention
2 Usual Regimen
Usual bolus insulin dose at each meal

Primary outcomes1

Outcomes the sponsor listed as primary.

HbA1c Value After 28 Days
Time frame · 28
Registry description
HbA1c values 28 days after randomization

Secondary outcomes(1)

Weight Change After 28 Days Intervention Period
Time frame · 28 days
Registry description
Mean weight change after 28 days intervention period

Posted results

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

Primary outcome results

Primary outcomeMean· 28

HbA1c Value After 28 Days

Group	Value (HbA1c %)	Spread
1 Symlin	7.94	0.71
2 Usual Regimen	8.72	0.44

Secondary and other outcome results(1)

Secondary outcomeMean· 28 days

Weight Change After 28 Days Intervention Period

Group	Value (kg)	Spread
1 Symlin	-0.84	0.24
2 Usual Regimen	0.04	0.62

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
1 SymlinSubcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	–	0 / 0	0 / 0
2 Usual RegimenUsual bolus insulin dose at each meal	–	0 / 0	0 / 0

Each cell reads participants affected / participants at risk, as the registry posted them.

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 · 2009

6 results

A pilot trial of pramlintide home usage in adolescents with type 1 diabetes.

Kishiyama et al. 2009Pediatricscited by 13

PMID 19858155DOI 10.1542/peds.2008-3750PUB-19858155

Full text at the publisher6 results

Publisher page See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 13 Years up to 17 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Between 13 and 17 years of age, inclusive * Diagnosed with type 1 diabetes for \> 1 year * Hemoglobin A1c between 7.5 and 10% inclusive * Currently using carbohydrate to insulin ratio * Acceptable form of birth control Exclusion Criteria: * Use of oral hyperglycemic agents or medications affecting blood sugar levels * Recurrent severe hypoglycemia requiring assistance in past 6 months * History of hypoglycemia unawareness * History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility * Previous use of pramlintide

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