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

July 26, 2016 updated by: KVS Hari Kumar, Command Hospital, India
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • UP
      • Lucknow, UP, India, 226002
        • Command Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Insulin alone
Type 1 DM only on Insulin
Drug: Insulin
Exenatide Sitagliptin
Other Names:
  • Premixed Insulin
Active Comparator: Insulin and Exenatide
Newly detected Type 1 DM on Insulin and exenatide
Drug: Exenatide
Exenatide 10 micrograms daily twice
Other Names:
  • GLP 1 analogues
Active Comparator: Insulin and Sitagliptin
Newly detected Type 1 DM using Insulin and Sitagliptin
Drug: Sitagliptin
Sitagliptin 100 mg per day oral
Other Names:
  • DPP 4 inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the end of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Command Hospital, India

Investigators

  • Study Director: The Commandant, MD, Command Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 5, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM/CHCC/03/2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not permitted

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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