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

October 17, 2014 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo Comparator
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.
Drug: Pramlintide acetate
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.
Drug: Pramlintide acetate
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.
Drug: Pramlintide acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment
Time Frame: AUC 0-3 hrs compared to Placebo
AUC 0-3 hrs compared to Placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
Incremental AUC (0-3 h) of plasma glucagon
Time Frame: 0-3 hrs compared to Placebo
0-3 hrs compared to Placebo
Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.
Time Frame: 0-3 hrs compared to Placebo
0-3 hrs compared to Placebo
PK of pramlintide
Time Frame: 0-3 hrs compared to Placebo
0-3 hrs compared to Placebo
Safety
Time Frame: 0-3 hrs compared to Placebo
0-3 hrs compared to Placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Juvenile Diabetes Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 17, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5570C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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