Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
A Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety of Pramlintide Treatment Employing Pramlintide Dose-Titration Followed by Insulin Dose Optimization in Subjects With Type 1 Diabetes Mellitus Who Have Not Achieved Glycemic Targets With Intensive Insulin Therapy
1 other identifier
interventional
296
1 country
33
Brief Summary
This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2002
Shorter than P25 for phase_3
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 30, 2002
CompletedFirst Posted
Study publicly available on registry
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedSeptember 23, 2015
August 1, 2015
11 months
July 30, 2002
September 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
- To investigate the safety of pramlintide treatment employing dose titration upon initiation of pramlintide followed by insulin dose optimization in subjects with type 1 diabetes.
29 Weeks
Secondary Outcomes (2)
- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
29 Weeks
- To examine the pattern of daily insulin use over the course of the study.
29 Weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.Ingredients: D-Mannitol 43.0 mg/mL Metacresol 2.25 mg/mL Glacial acetic acid 1.53 mg/mL Sodium acetate trihydrate 0.61 mg/mL pH 4.0 Water for injection qs to 5.0 mL
Pramlintide Acetate (AC137)
ACTIVE COMPARATORPramlintide acetate (AC137) injection is a clear, colorless, sterile solution for SC injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43 mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide injection is 0.6 mg/mL
Interventions
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
Eligibility Criteria
You may qualify if:
- HbA1c value between 7.5-9%
- Using multiple daily insulin injections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (33)
Ana Ventures LLC
Mesa, Arizona, 85204, United States
Phoenix Endocrinology Clinic, Ltd.
Phoenix, Arizona, 85006, United States
East Bay Clinical Trial Center
Concord, California, United States
Valley Research
Fresno, California, United States
UCSD Diabetes Research Center
San Diego, California, United States
Diabetes Research Institute
San Mateo, California, United States
Sansum Medical Research Institute
Santa Barbara, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262, United States
MedStar Clinical Research Center
Washington D.C., District of Columbia, United States
Medical Research Unlimited
Aventura, Florida, 33180, United States
Medical Research Unlimited
Aventura, Florida, United States
Internal Medicine Associates
Fort Myers, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Children's Clinic
Tallahassee, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
St. James Diabetes Center
Chicago Heights, Illinois, 60411, United States
St. James Diabetes Center
Chicago Heights, Illinois, United States
Indiana University Outpatient Clinical Research
Indianapolis, Indiana, United States
University of Maryland Joslin Diabetes Center
Baltimore, Maryland, 21012, United States
Henry Ford Health System
Detroit, Michigan, United States
Grand Rapids Associated Interns
Grand Rapids, Michigan, United States
Radiant Research
St Louis, Missouri, 63141, United States
Mercury Street Medical
Butte, Montana, United States
UNC Diabetes Care Center
Durham, North Carolina, 27713, United States
Ohio State Univ.-Division of Endocrinology, Diabetes
Columbus, Ohio, 43210, United States
Radiant Research
Portland, Oregon, United States
Physicians for Clinical Research
Camp Hill, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
North Texas Clinical Research
Irving, Texas, United States
Private Practice
Lufkin, Texas, 75904, United States
Private Practice
Lufkin, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
Related Publications (1)
Herrmann K, Frias JP, Edelman SV, Lutz K, Shan K, Chen S, Maggs D, Kolterman OG. Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy. Postgrad Med. 2013 May;125(3):136-44. doi: 10.3810/pgm.2013.05.2635.
PMID: 23748514DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2002
First Posted
August 1, 2002
Study Start
April 1, 2002
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
September 23, 2015
Record last verified: 2015-08