Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

What Was Tested

This registered phase 2 trial tested Amylin (Islet Amyloid Polypeptide).

Study DFA102E is an extension of Study DFA102, which included a 28-week treatment period with randomized study medication.

The purpose of the extension study is to examine the long-term (up to 1 year) safety, tolerability, and effect on body weight of treatment with pramlintide and metreleptin, administered as separate subcutaneous (SC) injections, in obese and overweight subjects.

It had four arms (groups): 1 (placebo comparator), 2 (experimental), 3 (experimental) and 4 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 274 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Completed Study DFA102, including all procedures required at the Study Termination visit, without major protocol deviations. Male, or female and meets all the following criteria:. Has a negative urine pregnancy test result at Study start(not applicable to hysterectomized females). If of childbearing potential must practice and be willing to continue to practice appropriate birth control during the entire duration of the study.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: is expected to require or undergo treatment with any exclusionary medication; is undesirable as a study participant as judged by the investigator.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Amylin (Islet Amyloid Polypeptide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2008-11 with completion listed for 2009-10.

It ran at 33 sites in United States (33).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: LS Mean Percent Change in Body Weight From Original Study DFA102 (NCT00673387) Baseline (Day 1) at Week 52 in Extension Study DFA102E - Evaluable Treatment Stable Population (time frame: Original Study Baseline to Week 52).

It also tracked 19 secondary outcomes, for example Mean Change in Systolic and Diastolic Blood Pressure From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population, Mean Change in Heart Rate From Baseline of DFA102 at Week 52 of DFA102E - Intent to Treat Population and Mean Change From DFA102 Screening at Week 52 in Study DFA102E for Electrocardiogram Parameters - Intent to Treat Population.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Amylin (Islet Amyloid Polypeptide) in 274 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.