Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus (GLP-1)

National University of Malaysia

Status: Completed

Conditions: Type 2 Diabetes Mellitus; PreDiabetes

Treatments: Drug: Sitagliptin

Study type: Interventional

Funder types: Other

Identifiers

NCT03659461

UKM-22

Details and patient eligibility

About

This study is conducted to examine GLP-1, insulin resistance and insulin sensitivity portfolio in Malay, Chinese and Indian populations in Malaysia and to study the effect of DPPIV inhibitor in T2DM patients with different GLP-levels.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects are newly diagnosed of T2DM according to World Health Organisation criteria) and do not receive any glucose-lowering drugs
• Subjects with normal glucose tolerance test according to World Health Organisation criteria which is carried out immediately before inclusion in the study
• Subjects who are willing to participate and sign the informed consent form

Exclusion criteria

• Patients with pre-existing T2DM
• Patients with family history of diabetes
• Patients receiving glucose-lowering medications
• Patients with anemia, abnormal serum creatinine level, macroalbuminuria, proliferative retinopathy, impaired liver function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

174 participants in 2 patient groups

low GLP-1 arm

Experimental group

Description:

Subjects are required to take oral 100mg Sitagliptin (Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin

Treatment:

Drug: Sitagliptin

normal GLP-1 arm

Active Comparator group

Description:

Subjects are required to take oral 100mg Sitagliptin ( Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin

Treatment:

Drug: Sitagliptin