Trial · Interventional

CompletedPhase 4Results postedRegistry data

Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus

NCTNCT00442767Other idH-18629Other idGCRC protocol #:0954

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 8 participants (actual)
Sponsor: Montefiore Medical Center · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Feb 2007
Primary completion: Feb 2009
Completion: Feb 2009
First posted: 2 Mar 2007 (estimated)
Last update posted: 10 Jul 2018
Conditions: Type 1 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

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

2007200820092010

Ph 4
Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
NCT00442767
Feb 2007 to Feb 2009

Registry summary

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

The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions. The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.

Interventions

InsulinDrug
Pramlintide + InsulinDrug

Arms2

Active comparator
Rapid acting Insulin therapy - before meal
Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal
Experimental
Pre-meal Pramlintide and Post-meal Insulin therapy
30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.

Primary outcomes1

Outcomes the sponsor listed as primary.

Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone
Time frame · 0 to 240 minutes post-dose
Registry description
Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone

Secondary outcomes(1)

Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.
Time frame · 0 to 120 minutes post-dose
Registry description
Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone

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· 0 to 240 minutes post-dose

Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone

Group	Value (mmol*L/min)	Spread
Rapid Acting Insulin Therapy - Before Meal	205	116
Pre-meal Pramlintide and Post-meal Insulin Therapy	993	141

Secondary and other outcome results(1)

Secondary outcomeMean· 0 to 120 minutes post-dose

Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.

Group	Value (ng*L/min)	Spread
Rapid Acting Insulin Therapy - Before Meal	6060	459
Pre-meal Pramlintide and Post-meal Insulin Therapy	7575	479

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Insulin TherapyRapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.	0 / 8	0 / 8	0 / 8
Pramlintide + Insulin TherapyPre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.	0 / 8	0 / 8	0 / 8

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: Clinical trial · 2009

3 results

Reducing postprandial hyperglycemia with adjuvant premeal pramlintide and postmeal insulin in children with type 1 diabetes mellitus.

Hassan et al. 2009Pediatric diabetescited by 14

PMID 19140902DOI 10.1111/j.1399-5448.2008.00490.xPUB-19140902

Full text at the publisher3 results

Publisher page See results (3)

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: * Type 1 diabetes only * Diagnosed with T1DM for at least 1 year * HbA1C less than or equal to 8.5% * Currently treated using insulin glargine with or without Humalog/ Novolog or on the insulin pump * Hemoglobin equal to or greater than 12mg/dL * Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism * Negative pregnancy test, in the case of females Exclusion Criteria: * Lack of supportive family * Evidence or history of chemical abuse * BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age * Patient who is poorly compliant with current insulin management and/or Prescribed self blood glucose monitoring * Patient who experiences recurrent severe hypoglycemia episodes (requiring assistance/ hospitalizations) in the past 6 months * Have hypoglycemia unawareness * Have a confirmed diagnosis of gastroparesis, and/ or require medications that stimulate gastrointestinal motility * Pregnant or lactating patients, or patients planning on becoming pregnant

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