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Trial · Interventional

CompletedNot applicableRegistry data

The Effect of Pramlintide on Meal Time Insulin Bolus

NCTNCT00460304 (opens ClinicalTrials.gov in a new tab)Other id07-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
12 participants (estimated)
Sponsor
Diabetes Care Center · Industry
Design
Not randomized · Open label (no masking)
Countries
Not stated
Start
Sept 2007
Primary completion
Nov 2008
Completion
Nov 2008
First posted
13 Apr 2007 (estimated)
Last update posted
3 Apr 2009 (estimated)
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. N/A

    The Effect of Pramlintide on Meal Time Insulin Bolus

    NCT00460304

    Sept 2007 to Nov 2008

Registry summary

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

The primary objective is to establish the mean percentage of change in the insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6 mcg before each meal is reached. The secondary objective is to establish which insulin bolus wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated with maximum pramlintide dosage.

Interventions

  • pramlintideDrug
  • continuous glucose monitoringProcedure

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The mean ICR from Vist 3a-e and 4a-e will be compared. Percentage reduction of ICR will be calculated. From these the mean ICR will be calculated.

    Time frame · 12-10-07

Secondary outcomes(1)

  1. The mean post-meal glucose from the four hour period after beginning a meal will be averaged for each bolus wave form. Then the three wave form mean glucose results will be compared.

    Time frame · 12-10-07

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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 · 2006

6 results

A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes.

Edelman et al. 2006Diabetes carecited by 115

PMID 17003291DOI 10.2337/dc06-0042PUB-17003291

Rights unknown6 results
Source linkSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age: \>17 * Type I diabetes * Onset of diabetes \>3 months * Use of insulin pump \>3 months * Hb A1C \<8.9% * Demonstrated compliance to clinic visits * Demonstrated knowledge and use of bolus dosing calculations, carbohydrate counting, use of insulin pump and blood glucose meter * Monitor blood glucose \>4/day Exclusion Criteria: * Pregnancy or nursing * Recent (within last 3 months) factor that may cause change in insulin sensitivity, e.g. severe emotional or physical stress, recent significant infection or surgery. etc. * Renal failure (creatinine \>1.5 mg/dl * Symptomatic gastroparesis * Using a medication that would interfere with insulin sensitivity * Treatment with extenatide or DPP IV inhibitor within the last 4 weeks * HbA1C change \>0.9 % within the last 3 months * Significant change in eating or activity pattern * Weight change of \>1.9 kg within the last 3 months * ALT \>3 times upper limits of normal

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