← Human Trials & Peer-Reviewed Studies
Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus
Plain-language guide to NCT00107107: phase 3 interventional trial of Amylin (Islet Amyloid Polypeptide), 190 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00107107
- Phase
- phase 3
- Status
- completed
- Start
- 2002-11
- Completion (planned or actual)
- 2005-06
- Participants
- 190 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Amylin (Islet Amyloid Polypeptide).
This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.
It had 1 arm (groups): Pramlintide Acetate (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 190 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 1 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was single-group and open-label.
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.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2002-11 with completion listed for 2005-06.
It ran at 25 sites in United States (25).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: To investigate the long term safety profile of pramlintide treatment in subjects with type 1 diabetes completing protocol 137-150. To examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight.
It also tracked 1 secondary outcome, for example To examine the effects of long term pramlintide treatment on HbA1c in subjects with type 1 diabetes completing protocol 137-150.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Amylin (Islet Amyloid Polypeptide) in 190 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.