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Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide
Plain-language guide to NCT00044707: phase 2 randomized trial of Amylin (Islet Amyloid Polypeptide), 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00044707
- Phase
- phase 2
- Status
- completed
- Start
- 2002-08
- Completion (planned or actual)
- 2002-09
- Participants
- 24 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Diabetes Mellitus, Non-Insulin-Dependent
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Amylin (Islet Amyloid Polypeptide).
It had two arms (groups): Pramlintide acetate (AC137) (active comparator) and Placebo (placebo comparator).
Placebo solution is the same, sterile preserved formulation, except the active ingredient, pramlintide, is omitted.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 24 actual participants took part.
It was open to people of any sex aged from 18 years up to 60 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes mellitus treated with diet and/or oral agents.
The full record lists 2 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, crossover and single-blind study.
Random assignment meant chance, not the researchers, decided who got Amylin (Islet Amyloid Polypeptide) and who got the comparison, which limits bias.
In the crossover set-up each of the participants took both Amylin (Islet Amyloid Polypeptide) and the comparison in turn, acting as their own control.
In this single-blind Amylin (Islet Amyloid Polypeptide) study one party knew the assignments and the other did not.
It started in 2002-08 with completion listed for 2002-09.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: To determine the effect of pramlintide on the PK of an oral medication (time frame: 7 Days).
It also tracked 1 secondary outcome, for example safety and tolerability as measured by analysis of laboratory values and adverse events.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 24 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.
Our Notes on the Compound
Amylin (Islet Amyloid Polypeptide): A 37-amino-acid hormone released with insulin that slows stomach emptying and signals fullness; pramlintide (Symlin) is a synthetic version.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.