Continuous Subcutaneous Infusion of Pramlintide and Insulin

NCT00291772 | Completed Phase 4 DMC

• 1 other identifier: H-17339
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if giving the study drug in a slow and steady dose will lower blood sugars during the meal and after-meal time.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; hypoglycemia; hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Area under the curve for glucose

  4 hrs

Secondary Outcomes (1)

• glucagon and gastric emptying

  4 hrs

Interventions

Pramlintide DRUG

Basal and bolus pramlintide subcutaneous infusion

Also known as: Symlin

Eligibility Criteria

• Age: 13 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be
• years of age at the time of enrollment.
• Have been diagnosed with diabetes for at least 1 year and in good control (HbA1C less than or equal to 8.5%).
• Be on continuous subcutaneous insulin infusion using an insulin pump.
• Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.
• Menstruating women must have a negative pregnancy test.
• Hemoglobin equal to or greater than 12 g/dL before each study.
• Weight more than 44 kg. -

You may not qualify if:

• Age greater than 23 years or less than 13 years at the time of study
• Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism stable on medications
• Anemia (hemoglobin less than 12mg/dl)
• Lack of a supportive family environment
• Positive pregnancy test in menstruating young women
• Evidence or history of chemical abuse
• Hgb A1C greater than 8.5 % in a diabetic subject
• BMI \> 90 % tile for age or \< 10 % tile for age
• Weight less than 44 kg. -

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Heptulla RA, Rodriguez LM, Bomgaars L, Haymond MW. The role of amylin and glucagon in the dampening of glycemic excursions in children with type 1 diabetes. Diabetes. 2005 Apr;54(4):1100-7. doi: 10.2337/diabetes.54.4.1100.

  PMID: 15793249 RESULT

• Heptulla RA, Rodriguez LM, Mason KJ, Haymond MW. Twenty-four-hour simultaneous subcutaneous Basal-bolus administration of insulin and amylin in adolescents with type 1 diabetes decreases postprandial hyperglycemia. J Clin Endocrinol Metab. 2009 May;94(5):1608-11. doi: 10.1210/jc.2008-2580. Epub 2009 Feb 3.

  PMID: 19190104 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Hyperglycemia

Interventions

pramlintide

Condition Hierarchy (Ancestors)

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

Study Officials

• Rubina Heptulla, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 15, 2006
• Study Start: January 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (1)