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

Sponsor

National University of Malaysia (Other)

Overall Status

Completed

CT.gov ID

NCT03659461

Collaborator

(none)

174

Enrollment

Location

Arms

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus PreDiabetes	Drug: Sitagliptin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Comparative Study of Incretin System in Three Ethnic Groups With Abnormal Glucose Tolerance

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jan 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low GLP-1 arm 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	Drug: Sitagliptin oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.
Active Comparator: normal GLP-1 arm 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	Drug: Sitagliptin oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.

Arm

Intervention/Treatment

Experimental: low GLP-1 arm

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

Drug: Sitagliptin

oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.

Active Comparator: normal GLP-1 arm

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

Drug: Sitagliptin

oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.

Outcome Measures

Primary Outcome Measures

change in blood glucose load response to sitagliptin [pre-treatment of sitagliptin and post 12-week treatment of sitagliptin]
change from blood glucose response at 12 weeks
change in blood insulin response to sitagliptin [pre-treatment of sitagliptin and post 12-week treatment of sitagliptin]
change from blood insulin response at 12 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Sultan Ismail	Johor Bahru	Johor	Malaysia	81100

Sponsors and Collaborators

National University of Malaysia

Investigators

Study Director: Kamaruddin Nor Azmi, National University of Malaysia
Principal Investigator: Shiau Chin Chong, National University of Malaysia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chong Shiau Chin, Pharmacist, National University of Malaysia

ClinicalTrials.gov Identifier:

NCT03659461

Other Study ID Numbers:

UKM-22

First Posted:

Sep 6, 2018

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Sitagliptin Phosphate

Study Results

No Results Posted as of Mar 15, 2022