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Incretin Axis in Type 1 Diabetes Mellitus

NCT02725502 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-04-01

No results posted yet for this study

Summary

Type 1 diabetes is an autoimmune disorder characterized by beta cell destruction resulting in insulinopenia. Currently it is being treated with insulin. Dipeptidylpeptidase inhibitors (DPP4 inhibitors e.g. linagliptin \& sitagliptin) has been used for type 2 diabetes mellitus (T2DM) traditionally. Previous studies has shown that it is also effective in type 1 diabetes mellitus (T1DM), but the mechanism of action not well understood. This study will evaluate possible mechanism of action of linagliptin in T1DM patients.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Linagliptin

Baseline HbA1C will be assessed. Before starting treatment with linagliptin or placebo Mixed meal test will be conducted with the standard protocol. Morning dose of insulin to be omitted on the day of mixed meal test. During the mixed meal test glucose, C-peptide, GLP1 and glucagon will be measured at 0, 30, 60, 120, 180 minutes. 72 hour blood glucose profile to be monitored with continuous glucose monitoring system (CGMS). Markers of glucose control and glucose variability will be measured. Then we will randomly divide these patients in two group (linagliptin and placebo group). After 3 month period 72 hour blood glucose profile, HbA1C and Mixed meal test will be repeated to document any change in blood glucose profile.

DRUG

Placebo

Baseline HbA1C will be assessed. Before starting treatment with linagliptin or placebo. Mixed meal test will be conducted with the standard protocol. Morning dose of insulin to be omitted on the day of mixed meal test. During the mixed meal test glucose, C-peptide, GLP-1 and glucagon will be measured at 0, 30, 60, 120, 180 minutes. 72 hour blood glucose profile to be monitored with CGMS. Markers of glucose control and glucose variability will be measured. Then we will randomly divide these patients in two group (linagliptin and placebo group). After 3 month period 72 hour blood glucose profile, HbA1C and Mixed meal test will be repeated to document any change in blood glucose profile.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Sanjay Kr Bhadada, MD, DM · Department of Endocrinology, PGIMER, Chnadigarh India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-04-30
Completion
2016-05-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725502 on ClinicalTrials.gov