Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with type 1 diabetes on postprandial plasma glucose concentrations

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

Details

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

Criteria

Inclusion Criteria:

• Is 18 to 70 years old

• Is male, or is female and meets all the following criteria:

1. Not breastfeeding

2. 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:

1. Any antihyperglycemic agent other than insulin

2. Drugs that directly affect gastrointestinal motility (e.g., anticholinergic agents such as atropine)

3. 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:

1. Hepatic disease

2. Renal disease

3. Gastrointestinal disease

4. Pulmonary disease

5. Organ transplantation

6. 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).