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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; PreDiabetes
• Intervention / Treatment: Drug: Sitagliptin

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Hospital Sultan Ismail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in blood glucose load response to sitagliptin	change from blood glucose response at 12 weeks	pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
change in blood insulin response to sitagliptin	change from blood insulin response at 12 weeks	pre-treatment of sitagliptin and post 12-week treatment of sitagliptin

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 2, 2018
• First Posted (ACTUAL): September 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: UKM-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No