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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708044
• Other study ID #: D5570C00001
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2012
• Last updated: October 17, 2014
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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., a-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).

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Pramlintide acetate

Other:
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
United States	Research Site	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment		AUC 0-3 hrs compared to Placebo	No
Secondary	Incremental AUC (0-3 h) of plasma glucagon		0-3 hrs compared to Placebo	No
Secondary	Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.		0-3 hrs compared to Placebo	No
Secondary	PK of pramlintide		0-3 hrs compared to Placebo	No
Secondary	Safety		0-3 hrs compared to Placebo	No

External Links

•   ABA163_D5570C0001_CSR Synopsis