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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
History of Changes
  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:

U.S. FDA Resources

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
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

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
Exenatide
Sitagliptin
 Insulin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013