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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00042458

Enrollment

296

Registered

2002-08-01

Start date

2002-04-30

Completion date

2003-03-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

DRUGPramlintide acetate

Pramlintide injection will be supplied in 5-mL multidose glass vials with rubber stoppers.

DRUGPlacebo

The placebo injection will be supplied in the same 5-mL multidose glass vials with a rubber stopper.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
- 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026