Expired Study
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Phoenix, Arizona 85006


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

137-150


NCT ID:

NCT00042458


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AstraZeneca


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

296


Enrollment Type:

Actual


Study Dates

Start Date:April 2002
Completion Date:March 2003
Completion Type:Actual
Primary Completion Date:March 2003
Primary Completion Type:Actual
Verification Date:August 2015
Last Changed Date:September 22, 2015
First Received Date:July 30, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:- To examine the pattern of daily insulin use over the course of the study.
Time Frame:29 Weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:- To examine the change in HbA1c, postprandial glucose concentration, and body weight over the course of the study.
Time Frame:29 Weeks
Safety Issues:False
Outcome Type:Primary Outcome
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.
Time Frame:29 Weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Pramlintide acetate
Description:Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.
Arm Name:Pramlintide Acetate (AC137)
Intervention Type:Drug
Name:Placebo
Description:The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
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
Study Arm Type:Active Comparator
Arm Name:Pramlintide Acetate (AC137)
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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AstraZeneca

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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