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

• Status: Completed
• Trial end date: 2016-08-05
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Juvenile Diabetes Research Foundation
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc; Islet Amyloid Polypeptide; Pramlintide

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