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

November 5, 2010
September 19, 2011
November 2010
September 2011   (final data collection date for primary outcome measure)
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
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
12 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01235819
DM/CHCC/03/2010
No
KVS Hari Kumar, Command Hospital CC
Command Hospital, India
Not Provided
Not Provided
Command Hospital, India
November 2010

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