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

Command Hospital, India

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Drug: Insulin; Drug: Exenatide; Drug: Sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT01235819

DM/CHCC/03/2010

Details and patient eligibility

About

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

Full 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

Enrollment: 20 patients

Sex: All

Ages: 12 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 3 patient groups

Insulin alone

Active Comparator group

Description:

Type 1 DM only on Insulin

Treatment:

Drug: Insulin

Insulin and Exenatide

Active Comparator group

Description:

Newly detected Type 1 DM on Insulin and exenatide

Treatment:

Drug: Exenatide

Insulin and Sitagliptin

Active Comparator group

Description:

Newly detected Type 1 DM using Insulin and Sitagliptin

Treatment:

Drug: Sitagliptin