Current partner codePEPTIDESDE
NCT00842075·Not applicable·INTERVENTIONAL

Pramlintide in Adolescents With Type 1 Diabetes

Status

Completed

Phase

Not applicable

Enrollment

10

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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).

Full detailed description

Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are: * HbA1c level between 7.5 and 10% inclusive * Currently using carbohydrate to insulin ratio * Acceptable form of birth control Exclusion factors: * Oral hyperglycemic agents or medications which might affect blood sugar levels * Recurrent severe hypoglycemia requiring assistance in previous 6 months * Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility * Previous use of pramlintide The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. Meals will be controlled for carbohydrate, fat and protein content. Meals will be identical at each CTRC visit. After a baseline visit for all participants, randomization will occur to either Treatment or Control.Bolus insulin will be adjusted for participants when beginning pramlintide and will likely remain at a reduced rate throughout the trial. All participants will have access to staff to assist with insulin dosing. There will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study. Insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final visit of the study. Hypoglycemic events will be tracked, as well as any other adverse events.

Interventions

Treatment arms and agents.

DRUG

pramlintide

subcutaneous injection (15 mcg initial dose)prior to meals

Timeline

From registration to results.

  1. First posted

    Feb 12, 2009

  2. Study start

    Dec 2006

  3. Primary completion

    Dec 2009

  4. Study completion

    Dec 2009

  5. Results posted

    Oct 19, 2012

  6. Registry updated

    Jun 23, 2015

Outcomes

What the study measures.

Primary outcomes

HbA1c Value After 28 Days

Time frame · 28

HbA1c values 28 days after randomization

Secondary outcomes

Weight Change After 28 Days Intervention Period

Time frame · 28 days

Mean weight change after 28 days intervention period

Eligibility

Who can take part.

Minimum age
13 Years
Maximum age
17 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Barbara Davis Center

Aurora, Colorado, United States

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

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