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Trial · Interventional

CompletedPhase 4Registry data

Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus

Overview

Status
Completed
Phase
Phase 4
Enrollment
20 participants (actual)
Sponsor
Command Hospital, India · Other gov
Design
Randomized · Open label (no masking)
Countries
1 country

India

Start
Nov 2010
Primary completion
Sept 2011
Completion
Sept 2011
First posted
8 Nov 2010 (estimated)
Last update posted
27 Jul 2016 (estimated)
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020112012
  1. Ph 4

    Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus

    NCT01235819

    Nov 2010 to Sept 2011

Registry summary

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

To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.

Interventions

  • InsulinDrug
  • SitagliptinDrug
  • ExenatideDrug

Arms3

  • Active comparator

    Insulin alone

    Type 1 DM only on Insulin

  • Active comparator

    Insulin and Exenatide

    Newly detected Type 1 DM on Insulin and exenatide

  • Active comparator

    Insulin and Sitagliptin

    Newly detected Type 1 DM using Insulin and Sitagliptin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. change in insulin requirement

    Time frame · one year

    Registry description

    To assess the change in insulin requirement with use of GLP 1 analogues or DPP 4 inhibitors along with insulin in type 1 diabetes

Secondary outcomes(1)
  1. C peptide response

    Time frame · at the end of one year

    Registry description

    To assess the endogenous insulin secretion after one year of use of GLp 1 analogue and DPP 4 inhibitors

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

3 results

Addition of exenatide or sitagliptin to insulin in new onset type 1 diabetes: a randomized, open label study.

Hari Kumar et al. 2013Diabetes research and clinical practicecited by 80

PMID 23490599DOI 10.1016/j.diabres.2013.01.020PUB-23490599

Full text at the publisher3 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 30 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * T1DM \<3 months * GAD Antibody+ or Stimulated C peptide\<0.5 ng/ml * Ketosis at onset * Age \< 30 yr Exclusion Criteria: * Age \> 30 yr * Pancreas disease * Significant systemic disease

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