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OpenTrials
Completed

NCT Number: NCT01235819

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Command Hospital

Lucknow, Uttar Pradesh, 226002, India

About this study

Inclusion criteria

T1DM <3 months GAD Antibody+ Stimulated C peptide<0.5ng/ml Ketosis at onset Age < 30 yr Exclusion criteria Age > 30 yr Pancreatic disease significant systemic complication

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

Exenatide Sitagliptin

Other names: Premixed Insulin

Sitagliptin

Drug

Sitagliptin 100 mg per day oral

Other names: DPP 4 inhibitors

exenatide

Drug

Exenatide 10 micrograms daily twice

Other names: GLP 1 analogues

Primary outcomes

  1. change in insulin requirement

    Time frame: one year

    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. C peptide response

    Time frame: at the end of one year

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

Sponsors and collaborators

Lead sponsor

Command Hospital, India

Other Gov

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 8, 2010
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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