Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus

Study identifier:D5570C00002

ClinicalTrials.gov identifier:NCT02500979

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Single-Blind, Two-Way Crossover, Placebo-Controlled Phase I Study to Compare the 24-hour Glucose Profile and Safety of Pramlintide and Insulin, Co-Administered in a Fixed-Dose Ratio, versus Placebo and Insulin in Patients with Type 1 Diabetes Mellitus with Inadequate Glycemic Control

Medical condition

Type 1 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Study drug

Pramlintide acetate, Placebo, Lispro insulin U-100, Regular insulin U-100

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 17 Aug 2015

Primary Completion Date: 05 Aug 2016

Study Completion Date: 05 Aug 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2018 by AstraZeneca

Collaborators

Juvenile Diabetes Research Foundation

Inclusion and exclusion criteria

Inclusion Criteria

-Provision of informed consent prior to any study-specific procedures
-Female and/or male aged between 18 and 70 years
-Must have a prior diagnosis of T1DM
-Body mass index (BMI) <30 kg/m2
-Subjects are not on current treatment with pramlintide (Symlin) and have not received pramlintide during the 6-month period prior to enrollment
-Subjects should be willing to consume all of the components of the standardized meals administered during the study
-Negative serum pregnancy test for female subjects of childbearing potential
-Female subjects of childbearing potential must be 1 year postmenopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study
-Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study

Exclusion Criteria

-Recurrent severe hypoglycemia requiring assistance within 6 months before screening
-A history of hypoglycemia unawareness
-A confirmed diagnosis of gastroparesis
-Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications:
-Any oral antihyperglycemic agent or any other injectable antihyperglycemic agent that is not insulin
- Drugs that directly affect GI motility (eg, anticholinergic agents such as atropine)
- Drugs that slow the intestinal absorption of nutrients (eg, α-glucosidase inhibitors
-A history of gastric surgery (such as gastric banding, Roux- and Y bypass)
-Is expected to require or undergo treatment with acetaminophen after enrollment and at any point during the study
-Has experienced diabetic ketoacidosis within the last 24 weeks
-History of hospitalization within the last 6 months for glycemic control (for both hyperglycemia or hypoglycemia)
-Subject has any significant disease or disorder, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study
- Any clinically relevant abnormal findings, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study.
-Pregnancy confirmed by a positive pregnancy test, or otherwise verified.
-Breast feeding
-Positive hepatitis C virus antibody (HCV Ab), hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (anti-Hbc), or human immunodeficiency virus 1/2 antibody (HIV-1/2 Ab) at Screening
-History of, or current alcohol or drug abuse
-Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate blood during the study
-Has had a major surgery or a blood transfusion within 2 months before Visit 1 (screening)
-Participation in any clinical study with an investigational drug or new formulation of a marketed drug during the last 1 month prior to Visit 1

Location

Research Site

Portland, OR, United States, 97239

Location

Research Site

Chula Vista, CA, United States, 91911

Location

Research Site

Chattanooga, TN, United States, 37411

Arms	Assigned Interventions
Experimental: Pramlintide acetate & regular insulin Pramlintide will be adiministered by sc infusion at a concentration of 1000ug/mL	Drug: Pramlintide acetate Pramlintide acetate administered by a separate pump Other Name: Pramlintide: SYMLIN Drug: Lispro insulin U-100 Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5) Other Name: Humalog insulin lispro U-100 Drug: Regular insulin U-100 Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump Other Name: Humulin R; U-100
Placebo Comparator: Placebo and regular insulin Placebo is similar sterile solution without pramlintide.	Drug: Placebo Placebo administered by separate pump Drug: Lispro insulin U-100 Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5) Other Name: Humalog insulin lispro U-100 Drug: Regular insulin U-100 Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump Other Name: Humulin R; U-100

Arms

Assigned Interventions

Experimental: Pramlintide acetate & regular insulin
Pramlintide will be adiministered by sc infusion at a concentration of 1000ug/mL

Drug: Pramlintide acetate
Pramlintide acetate administered by a separate pump

Other Name: Pramlintide: SYMLIN

Drug: Lispro insulin U-100
Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5)

Other Name: Humalog insulin lispro U-100

Drug: Regular insulin U-100
Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump

Other Name: Humulin R; U-100

Placebo Comparator: Placebo and regular insulin
Placebo is similar sterile solution without pramlintide.

Drug: Placebo
Placebo administered by separate pump

Other Name: Humalog insulin lispro U-100

Drug: Regular insulin U-100
Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump

Other Name: Humulin R; U-100

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

Peter Ohman

Investigators

Principal Investigator

Peter Ohman

Medical Director AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Trial Results Summaries