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Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pramlintide acetate
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HbA1c value between 7.5-9% Using multiple daily insulin injections

Sites / Locations

  • Ana Ventures LLC
  • Phoenix Endocrinology Clinic, Ltd.
  • East Bay Clinical Trial Center
  • Valley Research
  • UCSD Diabetes Research Center
  • Diabetes Research Institute
  • Sansum Medical Research Institute
  • Diablo Clinical Research
  • Barbara Davis Center for Childhood Diabetes
  • MedStar Clinical Research Center
  • Medical Research Unlimited
  • Medical Research Unlimited
  • Internal Medicine Associates
  • Suncoast Clinical Research
  • Children's Clinic
  • Atlanta Diabetes Associates
  • St. James Diabetes Center
  • St. James Diabetes Center
  • Indiana University Outpatient Clinical Research
  • University of Maryland Joslin Diabetes Center
  • Henry Ford Health System
  • Grand Rapids Associated Interns
  • Radiant Research
  • Mercury Street Medical
  • UNC Diabetes Care Center
  • Ohio State Univ.-Division of Endocrinology, Diabetes
  • Radiant Research
  • Physicians for Clinical Research
  • Vanderbilt University Medical Center
  • North Texas Clinical Research
  • Private Practice
  • Private Practice
  • Rainier Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Pramlintide Acetate (AC137)

Arm Description

Placebo 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) 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

Outcomes

Primary Outcome Measures

- 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.

Secondary Outcome Measures

- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
- To examine the pattern of daily insulin use over the course of the study.

Full Information

First Posted
July 30, 2002
Last Updated
September 22, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00042458
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 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
Arm Title
Pramlintide Acetate (AC137)
Arm Type
Active Comparator
Arm Description
Pramlintide 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
Intervention Type
Drug
Intervention Name(s)
Pramlintide acetate
Intervention Description
Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
Primary Outcome Measure Information:
Title
- 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.
Time Frame
29 Weeks
Secondary Outcome Measure Information:
Title
- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
Time Frame
29 Weeks
Title
- To examine the pattern of daily insulin use over the course of the study.
Time Frame
29 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HbA1c value between 7.5-9% Using multiple daily insulin injections
Facility Information:
Facility Name
Ana Ventures LLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85204
Country
United States
Facility Name
Phoenix Endocrinology Clinic, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
East Bay Clinical Trial Center
City
Concord
State/Province
California
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
Country
United States
Facility Name
UCSD Diabetes Research Center
City
San Diego
State/Province
California
Country
United States
Facility Name
Diabetes Research Institute
City
San Mateo
State/Province
California
Country
United States
Facility Name
Sansum Medical Research Institute
City
Santa Barbara
State/Province
California
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
MedStar Clinical Research Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Medical Research Unlimited
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Medical Research Unlimited
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Internal Medicine Associates
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Children's Clinic
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
St. James Diabetes Center
City
Chicago Heights
State/Province
Illinois
ZIP/Postal Code
60411
Country
United States
Facility Name
St. James Diabetes Center
City
Chicago Heights
State/Province
Illinois
Country
United States
Facility Name
Indiana University Outpatient Clinical Research
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
University of Maryland Joslin Diabetes Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21012
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Grand Rapids Associated Interns
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
Radiant Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
Country
United States
Facility Name
UNC Diabetes Care Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Ohio State Univ.-Division of Endocrinology, Diabetes
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Radiant Research
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Physicians for Clinical Research
City
Camp Hill
State/Province
Pennsylvania
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
North Texas Clinical Research
City
Irving
State/Province
Texas
Country
United States
Facility Name
Private Practice
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Private Practice
City
Lufkin
State/Province
Texas
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23748514
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.
Results Reference
derived

Learn more about this trial

Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

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