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

NCT01235819 | Completed Phase 4

• 1 other identifier: DM/CHCC/03/2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; exenatide; sitagliptin

Outcome Measures

Primary Outcomes (1)

• 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

  one year

Secondary Outcomes (1)

• C peptide response

  at the end of one year

Study Arms (3)

Insulin alone

ACTIVE COMPARATOR

Type 1 DM only on Insulin

Drug: Insulin

Insulin and Exenatide

ACTIVE COMPARATOR

Newly detected Type 1 DM on Insulin and exenatide

Drug: Exenatide

Insulin and Sitagliptin

ACTIVE COMPARATOR

Newly detected Type 1 DM using Insulin and Sitagliptin

Drug: Sitagliptin

Interventions

Insulin DRUG

Exenatide Sitagliptin

Also known as: Premixed Insulin

Insulin alone

Sitagliptin DRUG

Sitagliptin 100 mg per day oral

Also known as: DPP 4 inhibitors

Insulin and Sitagliptin

Exenatide DRUG

Exenatide 10 micrograms daily twice

Also known as: GLP 1 analogues

Insulin and Exenatide

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• T1DM \<3 months
• GAD Antibody+ or Stimulated C peptide\<0.5 ng/ml
• Ketosis at onset
• Age \< 30 yr

You may not qualify if:

• Age \> 30 yr
• Pancreas disease
• Significant systemic disease

Sponsors & Collaborators

• Command Hospital, India: lead

Study Sites (1)

Command Hospital

Lucknow, Uttar Pradesh, 226002, India

Location

Related Publications (1)

• 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.

  PMID: 23490599 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin; Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors; Exenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• The Commandant, MD

  Command Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 8, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)