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

NCT ID: NCT01235819

Last Updated: 2016-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin alone

Type 1 DM only on Insulin

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

Exenatide Sitagliptin

Insulin and Exenatide

Newly detected Type 1 DM on Insulin and exenatide

Group Type ACTIVE_COMPARATOR

Exenatide

Intervention Type DRUG

Exenatide 10 micrograms daily twice

Insulin and Sitagliptin

Newly detected Type 1 DM using Insulin and Sitagliptin

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Sitagliptin 100 mg per day oral

Interventions

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Insulin

Exenatide Sitagliptin

Intervention Type DRUG

Sitagliptin

Sitagliptin 100 mg per day oral

Intervention Type DRUG

Exenatide

Exenatide 10 micrograms daily twice

Intervention Type DRUG

Other Intervention Names

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GLP 1 analogues Premixed Insulin DPP 4 inhibitors

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Command Hospital, India

OTHER_GOV

Sponsor Role lead

Responsible Party

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KVS Hari Kumar

Endocrinologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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The Commandant, MD

Role: STUDY_DIRECTOR

Command Hospital

Locations

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Command Hospital

Lucknow, Uttar Pradesh, India

Site Status

Countries

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India

References

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Hari Kumar KV, Shaikh A, Prusty P. Addition of exenatide or sitagliptin to insulin in new onset type 1 diabetes: a randomized, open label study. Diabetes Res Clin Pract. 2013 May;100(2):e55-8. doi: 10.1016/j.diabres.2013.01.020. Epub 2013 Mar 13.

Reference Type DERIVED
PMID: 23490599 (View on PubMed)

Other Identifiers

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DM/CHCC/03/2010

Identifier Type: -

Identifier Source: org_study_id

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