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

NCT00442767 | Completed Phase 4 Results DMC

• 2 other identifiers: H-18629GCRC protocol #:0954
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

pediatric; juvenile; diabetes mellitus; Pediatric type 1 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

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

  Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone

  0 to 240 minutes post-dose

Secondary Outcomes (1)

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

  0 to 120 minutes post-dose

Study Arms (2)

Rapid acting Insulin therapy - before meal

ACTIVE COMPARATOR

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

Drug: Insulin

Pre-meal Pramlintide and Post-meal Insulin therapy

EXPERIMENTAL

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%.

Drug: Pramlintide + Insulin

Interventions

Insulin DRUG

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.

Also known as: aspart or lispro

Rapid acting Insulin therapy - before meal

Pramlintide + Insulin DRUG

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%.

Also known as: Pramlintide Acetate

Pre-meal Pramlintide and Post-meal Insulin therapy

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Hassan K, Heptulla RA. Reducing postprandial hyperglycemia with adjuvant premeal pramlintide and postmeal insulin in children with type 1 diabetes mellitus. Pediatr Diabetes. 2009 Jun;10(4):264-8. doi: 10.1111/j.1399-5448.2008.00490.x. Epub 2008 Dec 18.

  PMID: 19140902 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Insulin; Insulin Aspart; Insulin Lispro; pramlintide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Results Point of Contact

• Title: Dr. Rubina Heptulla
• Organization: Montefiore Medical Center

rheptull@montefiore.org

718-920-4664

Study Officials

• Rubina A Heptulla, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 2, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 10, 2018
• Results First Posted: July 10, 2018

Record last verified: 2018-06

Locations

US (1)