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

This study has been completed.
Sponsor:
Information provided by:
Command Hospital, India
ClinicalTrials.gov Identifier:
NCT01235819
First received: November 5, 2010
Last updated: September 19, 2011
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Type 1 Diabetes
Drug: Insulin
Drug: Sitagliptin
Drug: Exenatide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Command Hospital, India:

Primary Outcome Measures:
  • change in insulin requirement [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 [ Time Frame: at the end of one year ] [ Designated as safety issue: No ]
    To assess the endogenous insulin secretion after one year of use of GLp 1 analogue and DPP 4 inhibitors


Estimated Enrollment: 20
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin alone
Type 1 DM only on Insulin
Drug: Insulin
Exenatide Sitagliptin
Other Name: Premixed Insulin
Active Comparator: Insulin and Exenatide
Newly detected Type 1 DM on Insulin and exenatide
Drug: Exenatide
Exenatide 10 micrograms daily twice
Other Name: GLP 1 analogues
Active Comparator: Insulin and Sitagliptin
Newly detected Type 1 DM using Insulin and Sitagliptin
Drug: Sitagliptin
Sitagliptin 100 mg per day oral
Other Name: DPP 4 inhibitors

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

  Eligibility

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235819

Locations
India
Command Hospital
Lucknow, UP, India, 226002
Sponsors and Collaborators
Command Hospital, India
  More Information

No publications provided by Command Hospital, India

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: KVS Hari Kumar, Command Hospital CC
ClinicalTrials.gov Identifier: NCT01235819     History of Changes
Other Study ID Numbers: DM/CHCC/03/2010
Study First Received: November 5, 2010
Last Updated: September 19, 2011
Health Authority: United States: Federal Government
India: Med Div, CH CC

Keywords provided by Command Hospital, India:
type 1 diabetes
exenatide
sitagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Exenatide
Sitagliptin
Insulin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014