A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-06-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes who are not achieving glycemic targets.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Pramlintide

Group Type ACTIVE_COMPARATOR

pramlintide acetate

Intervention Type DRUG

Clear, colorless, sterile solution for SC injection

Interventions

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pramlintide acetate

Clear, colorless, sterile solution for SC injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Has HbA1c \>7.0% and \<=10.5%
* Has a body mass index (BMI) \>=25 kg/m2 and \<=45 kg/m2
* Has received insulin glargine for 3 months prior to study start and has been on a stable dose for 1 month prior to study start
* If taking oral antidiabetic agents, has been on a stable dose for at least 2 months

Exclusion Criteria

* Has been previously treated with Symlin/pramlintide (or has participated in a Symlin/pramlintide clinical study)
* Has received any investigational drug within 1 month of screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No