Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port

NCT00790699 | Terminated Results DMC

• 1 other identifier: TDE 001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether injecting Symlin and insulin through a multiple injection port is safe and effective. This will be measured by HbA1c values taken at the beginning of the study and at the final visit. The secondary objective of the study is to measure patient satisfaction toward using the multiple injection port.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

diabetes; Symlin; pramlintide acetate; insulin; multiple injection port; I-PORT

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Will be Measured by HbA1c Values Taken at Screening, Baseline and After Three Months.

  3 months

Secondary Outcomes (1)

• The Secondary Outcome Will Measure Patient Satisfaction, Opinions and Attitudes Toward Using the Multiple Injection Port for Insulin and Symlin Administration Compared to Standard Symlin Injections (Measured Through Using Questionnaires).

  3 months

Study Arms (2)

I-PORT

ACTIVE COMPARATOR

Treatment group

Device: I-PORT

standard injections

ACTIVE COMPARATOR

control group

Other: standard injections

Interventions

I-PORT DEVICE

The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.

I-PORT

standard injections OTHER

The study will compare injecting Symlin and insulin into a multiple injection port (I-PORT) vs. standard injections.

standard injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female ages 18 and up
• utilizing a regimen of at least two injections daily of insulin and at least two injections daily of Symlin
• able to understand and sign an informed consent form and HIPPA form
• agrees to all study visits and procedures
• HbA1c between \>6.5 and \<9.0 (inclusive)

You may not qualify if:

• history or current diagnosis of chronic disease which in the view of the PI would interfere with adequate involvement in and completion of the requirements of the study
• history of malignancy with in the last five years of study entry (other than basal cell carcinoma)
• current use of any drugs that alter gastrointestinal motility (e.g., anticholinergic agents such as atropine), agents that slow intestinal absorption of nutrients (e.g. a-glucosidase inhibitors) or promotility agents (e.g. metaclopromide)
• any contraindication of Symlin or I-PORT according to the package labeling
• are female and pregnant, lactating or planning to become pregnant during the duration of the trial
• are poorly compliant with their current insulin and/or Symlin regimen, as defined by their HCP
• has history of known hypersensitivity to plastics or polymers
• treatment with any investigational drug within one month prior to enrollment
• myocardial infarction or stroke within six months prior to screening
• initiated use of Symlin pen or any Insulin pen in lieu of a vial in last 4 weeks (pen use is okay as long as they have been using it for at least 4 weeks prior to screening visit)
• female subjects of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral contraceptives, double barrier methods, Intrauterine devices, surgical sterilization or vasectomized partner)
• have confirmed diagnosis of gastroparesis
• have hypoglycemia unawareness

Sponsors & Collaborators

• Texas Diabetes & Endocrinology, P.A.: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

Texas Diabetes & Endocrinology, PA

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Thomas Blevins,MD
• Organization: Texas Diabetes & Endocrinology

blevins@texasdiabetes.com

5812.334.3505

Study Officials

• Thomas C. Blevins, MD

  Texas Diabetes & Endocrinology

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thomas Blevins, MD

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 13, 2008
• Study Start: August 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-09

Locations

US (1)