Back to resultsEvaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
Primary Purpose
Diabetes Mellitus, Non-Insulin-Dependent
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pramlintide acetate
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Non-Insulin-Dependent focused on measuring Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes mellitus treated with diet and/or oral agents HbA1c 6.5-11.0
Sites / Locations
- ICSL-Clinical Studies
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Pramlintide acetate (AC137)
Placebo
Arm Description
Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL
Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted
Outcomes
Primary Outcome Measures
To determine the effect of pramlintide on the PK of an oral medication
To determine the effect of pramlintide on the pharmacokinetics of an orally administered concomitant medication (acetaminophen) when administered at various times in relation to subcutaneous (SC) pramlintide dosing. The noncompartmental plasma acetaminophen pharmacokinetic (PK) parameters used in the analyses are defined as follows: AUC(0-12hr): Area under the plasma acetaminophen concentration-time curve. Cmax : The peak acetaminophen concentrationd. Tmax : Duration from the time of acetaminophen dosing to the time of the first maximum observed concentration, Cmax.
t½: Terminal half-life
The primary study endpoints include:
pharmacokinetic parameters AUC(0-12 hr) and Cmax of plasma acetaminophen concentrations Secondary Study Endpoints
pharmacokinetic parameters Tmax and t1/2 of plasma acetaminophen concentrations
Secondary Outcome Measures
safety and tolerability as measured by analysis of laboratory values and adverse events
To assess safety and tolerability of pramlintide SC injection, including adverse events, as a function of the timing of an orally administered concomitant medication (acetaminophen).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00044707
Brief Title
Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-Insulin-Dependent
Keywords
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pramlintide acetate (AC137)
Arm Type
Active Comparator
Arm Description
Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted
Intervention Type
Drug
Intervention Name(s)
Pramlintide acetate
Intervention Description
Clear, colorless, sterile solution for SC injection.
Primary Outcome Measure Information:
Title
To determine the effect of pramlintide on the PK of an oral medication
Description
To determine the effect of pramlintide on the pharmacokinetics of an orally administered concomitant medication (acetaminophen) when administered at various times in relation to subcutaneous (SC) pramlintide dosing. The noncompartmental plasma acetaminophen pharmacokinetic (PK) parameters used in the analyses are defined as follows: AUC(0-12hr): Area under the plasma acetaminophen concentration-time curve. Cmax : The peak acetaminophen concentrationd. Tmax : Duration from the time of acetaminophen dosing to the time of the first maximum observed concentration, Cmax.
t½: Terminal half-life
The primary study endpoints include:
pharmacokinetic parameters AUC(0-12 hr) and Cmax of plasma acetaminophen concentrations Secondary Study Endpoints
pharmacokinetic parameters Tmax and t1/2 of plasma acetaminophen concentrations
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
safety and tolerability as measured by analysis of laboratory values and adverse events
Description
To assess safety and tolerability of pramlintide SC injection, including adverse events, as a function of the timing of an orally administered concomitant medication (acetaminophen).
Time Frame
7 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes mellitus treated with diet and/or oral agents
HbA1c 6.5-11.0
Facility Information:
Facility Name
ICSL-Clinical Studies
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
12. IPD Sharing Statement
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Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
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