Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
1 other identifier
interventional
274
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Nov 2008
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 24, 2008
CompletedFirst Posted
Study publicly available on registry
January 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
December 5, 2013
CompletedApril 15, 2015
March 1, 2015
11 months
December 24, 2008
August 12, 2013
March 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Original study DFA102 (NCT00673387) baseline refers to Visit 5 (Day 1). If Day 1 value was missing or after the first dose date of randomized study medication, the last available value on or prior to Day 1 was used. Least Squares (LS) Mean based on a repeated measures mixed model with treatment, sex, DFA102 baseline BMI category, nominal week, treatment by nominal week interaction as factors, and DFA102 baseline weight value as a covariate, with a heterogeneous compound symmetry error covariance structure within each treatment group. Stable population consists of all ITT participants (received at least one injection of treatment) who had the same treatment group assignment in Study DFA102 and Study DFA102E, ie, ITT participants who were in Study DFA102 treatment groups Placebo, Pramlintide 360 + Metreleptin 1.25, Pramlintide 360 + Metreleptin 2.5 and Pramlintide 360 + Metreleptin 5.0.
Original Study Baseline to Week 52
Secondary Outcomes (19)
LS Mean Absolute Change in Body Weight From Original Study Baseline (Day 1) at Weeks 12, 28, 36, 44, and 52 - Evaluable Treatment Stable Population
Original baseline to Week 52
Fasting Total Leptin Concentration by Visit and Pooled Metreleptin Stable Treatment by Metreleptin Dose - Week 52 Stable Evaluable Population
Original Study Baseline to Extension Week 52 and follow up
LS Mean Absolute Change in Waist Circumference From Baseline in the Original Study to Week 52 in the Extension Study - Week 52 Evaluable Stable Population
Baseline to Week 52
LS Mean Percent Change in Body Weight From Baseline of Original Study DFA102 at Week 12, and at Weeks 28, 36, 44, and 52 in the Extension Study DFA102E - Week 52 Evaluable Treatment Stable Population
Baseline to Week 52
LS Mean Absolute Change From Baseline in Original Study DFA102 to Week 52 in Extension Study DFA102E for Glucose and Lipids - Week 52 Evaluable Treatment Stable Population
Baseline (Day 1) to Week 52
- +14 more secondary outcomes
Study Arms (4)
1
PLACEBO COMPARATOR2
EXPERIMENTALPramlintide and 1.25mg Metreleptin
3
EXPERIMENTALPramlintide and 2.5mg Metreleptin
4
EXPERIMENTALPramlintide and 5.0mg Metreleptin
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Able to read, understand, and sign the Informed Consent Form (ICF) and if applicable,an Authorization to Use and Disclose Protected Health Information Form, answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements
You may not qualify if:
- Is undesirable as a study participant as judged by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (33)
Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arkansas, United States
Research Site
Santa Rosa, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Denver, Colorado, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Plantation, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Springfield, Illinois, United States
Research Site
Kansas City, Kansas, United States
Research Site
Baton Rouge, Louisiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Edina, Minnesota, United States
Research Site
St Louis, Missouri, United States
Research Site
Butte, Montana, United States
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Columbus, Ohio, United States
Research Site
Eugene, Oregon, United States
Research Site
Medford, Oregon, United States
Research Site
Anderson, South Carolina, United States
Research Site
Greer, South Carolina, United States
Research Site
Mt. Pleasant, South Carolina, United States
Research Site
Nashville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Norfolk, Virginia, United States
Research Site
Bellingham, Washington, United States
Research Site
Olympia, Washington, United States
Related Publications (1)
Chan JL, Koda J, Heilig JS, Cochran EK, Gorden P, Oral EA, Brown RJ. Immunogenicity associated with metreleptin treatment in patients with obesity or lipodystrophy. Clin Endocrinol (Oxf). 2016 Jul;85(1):137-49. doi: 10.1111/cen.12980. Epub 2016 Feb 2.
PMID: 26589105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Ohman, Medical Science Director
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Jean Chan, MD
Amylin Pharmaceuticals, LLC.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2008
First Posted
January 8, 2009
Study Start
November 1, 2008
Primary Completion
October 1, 2009
Study Completion
November 1, 2009
Last Updated
April 15, 2015
Results First Posted
December 5, 2013
Record last verified: 2015-03