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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Pramlintide acetate

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Pramlintide acetate

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Pramlintide acetate

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Comparator

Interventions

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Pramlintide acetate

Intervention Type DRUG

Placebo

Placebo Comparator

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No