Effect of different fixed pramlintide:insulin dose ratios on postprandial glucose in T1DM

Study identifier:D5570C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control in Subjects With Type 1 Diabetes Mellitus

Medical condition

Type 1 Diabetes

Phase

Phase 1

Healthy volunteers

Study drug

Pramlintide acetate

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 Nov 2012

Primary Completion Date: 01 Sept 2013

Study Completion Date: 01 Sept 2013

Study design

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2014 by AstraZeneca

Collaborators

AstraZeneca, Juvenile Diabetes Research Foundation

Inclusion and exclusion criteria

Inclusion Criteria

- Is 18 to 70 years old
- Is male, or is female and meets all the following criteria:
a. Not breastfeeding
b. Negative pregnancy test result and, if of childbearing potential, must practice and be willing to continue to practice appropriate birth control
- Has been diagnosed with type 1 diabetes mellitus for at least 1 year and not achieving glycemic goal while on MDI of insulin
- Has HbA1c between 7.0% and 9.0%
- Has been on MDI of regular insulin, at a dose not to exceed 10 units/breakfast for at least 3 months or has been on continuous subcutaneous insulin infusion (CSII), at a dose not to exceed 10 units/breakfast, for at least 3 months and is willing to switch to an MDI insulin regimen for 1 day prior to enrollment and through the study
- Has a body mass index (BMI) <30 kg/m2

Exclusion Criteria

- Has experienced recurrent severe hypoglycemia requiring assistance within 6 months before Visit 1 Screening
- Has a history of hypoglycemia unawareness
- Has a confirmed diagnosis of gastroparesis
- Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications:
a. Any antihyperglycemic agent other than insulin
b. Drugs that directly affect gastrointestinal motility (e.g., anticholinergic agents such as atropine)
c. Drugs that slow the intestinal absorption of nutrients (e.g., α-glucosidase inhibitors.
- Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
a. Hepatic disease
b. Renal disease
c. Gastrointestinal disease
d. Pulmonary disease
e. Organ transplantation
f. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
- Is currently treated or has been previously treated with SYMLIN/pramlintide or has participated in a SYMLIN/pramlintide clinical study within 3 months of Visit 1 (Screening).
- Has any clinically significant laboratory findings or medical history that may affect successful completion of the study and/or personal well-being
- Has donated blood within 2 months or is planning to donate blood during the study.
- Has had a major surgery or a blood transfusion within 2 months
- Has received any investigational drug within 1 month
- Has known allergies or hypersensitivity to any component of study treatment.
- Is an immediate family member of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with the study at the clinical study site.
- Is employed by Amylin Pharmaceuticals, Inc (Amylin) (that is an employee, temporary contract worker, or designee responsible for the conduct of the study).

Location

Research Site

Portland, OR, United States

Arms	Assigned Interventions
Experimental: Pramlintide 6 mcg per unit of insulin dose The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 6 mcg for each unit of insulin.	-
Experimental: Pramlintide 9 mcg per unit of insulin dose The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 9 mcg for each unit of insulin.	-
Experimental: Pramlintide 12 mcg per unit of insulin dose The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 12 mcg for each unit of insulin.	-
Placebo Comparator: Placebo	Other: Placebo Placebo Comparator

Documents available

ABA163_D5570C0001_CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

Peter Öhman

ClinicalTrialTransparency@astrazeneca.com

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

ABA163_D5570C0001_CSR Synopsis

Trial Results Summaries