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NCT00460304·Not applicable·INTERVENTIONAL

The Effect of Pramlintide on Meal Time Insulin Bolus

PramlintideOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

12

Locations

0

Results

Not posted

Publications

8

Study summary

What the protocol is testing.

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.

Full detailed description

Pramlintide. an amylinomimetic, is effective in reducing post-meal glucose by non-insulin means. As such, when patients requiring insulin treatment are treated with pramlintide, the bolus insulin does must be reduced. Current recommendations suggest a 50% reduction but in our experience and that of a recent study this appears excessive. By using continuous glucose monitoring(CGM) to guide pre-meal insulin treatment, we will determine the percentage reduction in meal time insulin bolus comparing pre-pramlintide to maximum pramlintide treatment. We anticipate that the reduction in bolus dosage will be about 25%. In addition, the secondary aim of this study is to determine which bolus pattern, standard, square or dual wave, provides the best post-meal glucose control with pramlintide therapy.

Interventions

Treatment arms and agents.

DRUG

pramlintide

PROCEDURE

continuous glucose monitoring

Timeline

From registration to results.

  1. First posted

    Apr 13, 2007

  2. Study start

    Sep 2007

  3. Primary completion

    Nov 2008

  4. Study completion

    Nov 2008

  5. Results posted

    Not reported

  6. Registry updated

    Apr 3, 2009

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

PMID 17003291 ↗Edelman S, Garg S, Frias J, Maggs D, Wang Y, Zhang B, Strobel S, Lutz K, Kolterman O. A double-blind, placebo-controlled trial assessing pramlintide treatment in the setting of intensive insulin therapy in type 1 diabetes. Diabetes Care. 2006 Oct;29(10):2189-95. doi: 10.2337/dc06-0042.PMID 18220597 ↗King AB, Armstrong DU. Basal bolus dosing: a clinical experience. Curr Diabetes Rev. 2005 May;1(2):215-20. doi: 10.2174/1573399054022794.PMID 19888377 ↗King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: Basal dosing. J Diabetes Sci Technol. 2007 Jan;1(1):36-41. doi: 10.1177/193229680700100106.PMID 19888378 ↗King AB, Armstrong DU. A prospective evaluation of insulin dosing recommendations in patients with type 1 diabetes at near normal glucose control: bolus dosing. J Diabetes Sci Technol. 2007 Jan;1(1):42-6. doi: 10.1177/193229680700100107.PMID 7672483 ↗Young AA, Gedulin B, Vine W, Percy A, Rink TJ. Gastric emptying is accelerated in diabetic BB rats and is slowed by subcutaneous injections of amylin. Diabetologia. 1995 Jun;38(6):642-8. doi: 10.1007/BF00401833.PMID 9005972 ↗Gedulin BR, Rink TJ, Young AA. Dose-response for glucagonostatic effect of amylin in rats. Metabolism. 1997 Jan;46(1):67-70. doi: 10.1016/s0026-0495(97)90170-0.PMID 10741687 ↗Rushing PA, Lutz TA, Seeley RJ, Woods SC. Amylin and insulin interact to reduce food intake in rats. Horm Metab Res. 2000 Feb;32(2):62-5. doi: 10.1055/s-2007-978590.PMID 11469628 ↗Gross TM, Mastrototaro JJ. Efficacy and reliability of the continuous glucose monitoring system. Diabetes Technol Ther. 2000;2 Suppl 1:S19-26. doi: 10.1089/15209150050214087. No abstract available.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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