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Evaluation of the Bioavailability of Pramlintide
Plain-language guide to NCT00042471: phase 2 randomized trial of Amylin (Islet Amyloid Polypeptide), 75 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00042471
- Phase
- phase 2
- Status
- completed
- Start
- 2002-06
- Completion (planned or actual)
- 2002-12
- Participants
- 75 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Amylin (Islet Amyloid Polypeptide).
This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.
It had 1 arm (groups): Pramlintide acetate (AC137) injection (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 75 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: BMI \<= 27 kg/m2 or BMI \>=30 to \<= 45 kg/m2. Consistent insulin regimen for 2 months prior to screening.
The full record lists 3 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, crossover and open-label study.
Because people in this Amylin (Islet Amyloid Polypeptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Each person switched between Amylin (Islet Amyloid Polypeptide) and the comparison at some point, usually with a gap in between.
Everyone knew when Amylin (Islet Amyloid Polypeptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2002-06 with completion listed for 2002-12.
It ran at 4 sites in United States (4).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Effect of varying needle length on bioavailability of Pramlintide (time frame: approximately 6days but not to exceed 14days).
It also tracked 1 secondary outcome, for example Effect of varying needle length on safety and tolerability of Pramlintide.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 75 people.
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.