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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235819
First Posted: November 8, 2010
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
KVS Hari Kumar, Command Hospital, India
November 5, 2010
November 8, 2010
July 27, 2016
November 2010
September 2011   (Final data collection date for primary outcome measure)
change in insulin requirement [ Time Frame: 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
Same as current
Complete list of historical versions of study NCT01235819 on ClinicalTrials.gov Archive Site
C peptide response [ Time Frame: 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
Same as current
Not Provided
Not Provided
 
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.
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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes
  • Drug: Insulin
    Exenatide Sitagliptin
    Other Name: Premixed Insulin
  • Drug: Sitagliptin
    Sitagliptin 100 mg per day oral
    Other Name: DPP 4 inhibitors
  • Drug: Exenatide
    Exenatide 10 micrograms daily twice
    Other Name: GLP 1 analogues
  • Active Comparator: Insulin alone
    Type 1 DM only on Insulin
    Intervention: Drug: Insulin
  • Active Comparator: Insulin and Exenatide
    Newly detected Type 1 DM on Insulin and exenatide
    Intervention: Drug: Exenatide
  • Active Comparator: Insulin and Sitagliptin
    Newly detected Type 1 DM using Insulin and Sitagliptin
    Intervention: Drug: Sitagliptin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 30 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01235819
DM/CHCC/03/2010
No
Not Provided
Plan to Share IPD: No
Plan Description: Not permitted
KVS Hari Kumar, Command Hospital, India
Command Hospital, India
Not Provided
Study Director: The Commandant, MD Command Hospital
Command Hospital, India
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP