Clinical trial NCT00042458: Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2002-08-01
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* HbA1c value between 7.5-9%
* Using multiple daily insulin injections

Primary outcomes:
measure: - 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.
timeFrame: 29 Weeks
Secondary outcomes:
measure: - To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
timeFrame: 29 Weeks
measure: - To examine the pattern of daily insulin use over the course of the study.
timeFrame: 29 Weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Ana Ventures LLC
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Endocrinology Clinic, Ltd.
state: Arizona
city: Concord
country: United States
facility: East Bay Clinical Trial Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: San Diego
country: United States
facility: UCSD Diabetes Research Center
state: California
city: San Mateo
country: United States
facility: Diabetes Research Institute
state: California
city: Santa Barbara
country: United States
facility: Sansum Medical Research Institute
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Denver
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Washington
country: United States
facility: MedStar Clinical Research Center
state: District of Columbia
city: Aventura
country: United States
facility: Medical Research Unlimited
state: Florida
city: Aventura
country: United States
facility: Medical Research Unlimited
state: Florida
city: Fort Myers
country: United States
facility: Internal Medicine Associates
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Tallahassee
country: United States
facility: Children's Clinic
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Chicago Heights
country: United States
facility: St. James Diabetes Center
state: Illinois
city: Chicago Heights
country: United States
facility: St. James Diabetes Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Outpatient Clinical Research
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Joslin Diabetes Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Grand Rapids Associated Interns
state: Michigan
city: St. Louis
country: United States
facility: Radiant Research
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Durham
country: United States
facility: UNC Diabetes Care Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State Univ.-Division of Endocrinology, Diabetes
state: Ohio
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Camp Hill
country: United States
facility: Physicians for Clinical Research
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Irving
country: United States
facility: North Texas Clinical Research
state: Texas
city: Lufkin
country: United States
facility: Private Practice
state: Texas
city: Lufkin
country: United States
facility: Private Practice
state: Texas
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
References:
citation: 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.