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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Insulin

Sitagliptin

Exenatide

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, exenatide, sitagliptin

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Command Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Insulin alone

Insulin and Exenatide

Insulin and Sitagliptin

Arm Description

Type 1 DM only on Insulin

Newly detected Type 1 DM on Insulin and exenatide

Newly detected Type 1 DM using Insulin and Sitagliptin

Outcomes

Primary Outcome Measures

change in insulin requirement

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 Outcome Measures

C peptide response

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

Full Information

NCT ID

NCT01235819

First Posted

November 5, 2010

Last Updated

July 26, 2016

Sponsor

Command Hospital, India

1. Study Identification

Unique Protocol Identification Number

NCT01235819

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Command Hospital, India

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

type 1 diabetes, exenatide, sitagliptin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin alone

Arm Type

Active Comparator

Arm Description

Type 1 DM only on Insulin

Arm Title

Insulin and Exenatide

Arm Type

Active Comparator

Arm Description

Newly detected Type 1 DM on Insulin and exenatide

Arm Title

Insulin and Sitagliptin

Arm Type

Active Comparator

Arm Description

Newly detected Type 1 DM using Insulin and Sitagliptin

Intervention Type

Drug

Intervention Name(s)

Insulin

Other Intervention Name(s)

Premixed Insulin

Intervention Description

Exenatide Sitagliptin

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

DPP 4 inhibitors

Intervention Description

Sitagliptin 100 mg per day oral

Intervention Type

Drug

Intervention Name(s)

Exenatide

Other Intervention Name(s)

GLP 1 analogues

Intervention Description

Exenatide 10 micrograms daily twice

Primary Outcome Measure Information:

Title

change in insulin requirement

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

Time Frame

one year

Secondary Outcome Measure Information:

Title

C peptide response

Description

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

Time Frame

at the end of one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

The Commandant, MD

Organizational Affiliation

Command Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Command Hospital

City

Lucknow

State/Province

ZIP/Postal Code

226002

Country

India

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Not permitted

Citations:

PubMed Identifier

23490599

Citation

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.

Results Reference

derived

Learn more about this trial

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

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