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

Phase 4

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Insulin; Drug: Exenatide; Drug: Sitagliptin

• Registration Number: NCT01235819
• Lead Sponsor: Command Hospital, India

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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-08
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin alone	Insulin	Type 1 DM only on Insulin
Insulin and Exenatide	Exenatide	Newly detected Type 1 DM on Insulin and exenatide
Insulin and Sitagliptin	Sitagliptin	Newly detected Type 1 DM using Insulin and Sitagliptin

Primary Outcome Measures

Name	Time	Method
change in insulin requirement	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 Outcome Measures

Name	Time	Method
C peptide response	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

Trial Locations

Locations (1)

Command Hospital; 🇮🇳 Lucknow, UP, India