Skip to content

Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT00240253 (opens ClinicalTrials.gov in a new tab)Other id137-156
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
200 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Oct 2005
Primary completion
Jun 2006
Completion
Jun 2006
First posted
18 Oct 2005 (estimated)
Last update posted
31 Mar 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007
  1. Ph 4

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

    NCT00240253

    Oct 2005 to Jun 2006

Registry summary

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

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.

Interventions

  • pramlintide acetateDrug

Arms1

  • Active comparator

    Pramlintide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. To evaluate the efficacy and safety of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes.

    Time frame · 16 Weeks

Secondary outcomes(1)

  1. To evaluate the effects of adding Symlin to an established regimen of insulin glargine in subjects with type 2 diabetes on markers of cardiovascular risk, fasting serum lipids, fasting plasma glucose, waist circumference, and patient-reported outcomes.

    Time frame · 16 Weeks

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

3 studies on this page

Indexing hint: Randomized controlled trial · 2008

11 results

Effect of pramlintide as an adjunct to basal insulin on markers of cardiovascular risk in patients with type 2 diabetes.

Wysham et al. 2008Current medical research and opinioncited by 21

PMID 18031595DOI 10.1185/030079908x253537PUB-18031595

Full text at the publisher11 results
Publisher pageSee results (11)

Indexing hint: Randomized controlled trial · 2008

2 results

Diabetes distress and its association with clinical outcomes in patients with type 2 diabetes treated with pramlintide as an adjunct to insulin therapy.

Peyrot et al. 2008Diabetes technology & therapeuticscited by 17

PMID 19049375DOI 10.1089/dia.2008.0031PUB-19049375

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Randomized controlled trial · 2007

5 results

Pramlintide improved glycemic control and reduced weight in patients with type 2 diabetes using basal insulin.

Riddle et al. 2007Diabetes carecited by 78

PMID 17698615DOI 10.2337/dc07-0589PUB-17698615

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.