Trial · Interventional

CompletedPhase 3Registry data

Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

NCTNCT00108004Other id137-155

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 400 participants (estimated)
Sponsor: AstraZeneca · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Apr 2003
Primary completion: Jun 2005
Completion: Jun 2005
First posted: 13 Apr 2005 (estimated)
Last update posted: 21 May 2015 (estimated)
Conditions: Type 1 Diabetes Mellitus · Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2003200420052006

Ph 3
Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus
NCT00108004
Apr 2003 to Jun 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Interventions

pramlintide acetateDrug

Arms1

Experimental
Pramlintide
Pramlintide acetate 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

Primary outcomes2

Outcomes the sponsor listed as primary.

To investigate the clinical utility and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus
Time frame · 6 months
Registry description
To investigate the clinical utility (change in HbA1c, seven-point glucose profile, body weight, and insulin use) and safety of pramlintide in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy.
Understand management issues in subjects with type 1 and type 2 diabetes mellitus
Time frame · 6 months
Registry description
To collect data regarding the selection of subjects for pramlintide administration by healthcare professionals and to further understand management issues in subjects with type 1 and type 2 diabetes mellitus who have not achieved glycemic targets with insulin therapy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2013

11 results

Pramlintide improved measures of glycemic control and body weight in patients with type 1 diabetes mellitus undergoing continuous subcutaneous insulin infusion therapy.

Herrmann et al. 2013Postgraduate medicinecited by 20

PMID 23748514DOI 10.3810/pgm.2013.05.2635PUB-23748514

Full text at the publisher11 results

Publisher page See results (11)

Indexing hint: Clinical trial · 2007

7 results

Pramlintide as an adjunct to insulin in patients with type 2 diabetes in a clinical practice setting reduced A1C, postprandial glucose excursions, and weight.

Karl et al. 2007Diabetes technology & therapeuticscited by 24

PMID 17425446DOI 10.1089/dia.2006.0013PUB-17425446

Full text at the publisher7 results

Publisher page See results (7)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2006

Pramlintide in the treatment of diabetes.

Edelman et al. 2006International journal of clinical practicecited by 13

PMID 17109671DOI 10.1111/j.1742-1241.2006.01187.xPUB-17109671

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * The subject has a clinical diagnosis of type 1 diabetes mellitus requiring treatment with insulin for a minimum of 6 months at Screening; -OR- The subject has a clinical diagnosis of type 2 diabetes requiring treatment with insulin with or without oral antidiabetic agents for a minimum of 6 months at Screening. * The subject has a HbA1c of 7.0% to 11.0% at Screening.

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