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

NCT03659461 | Completed DMC

• 1 other identifier: UKM-22
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; PreDiabetes

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

low GLP-1 arm

EXPERIMENTAL

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

normal GLP-1 arm

ACTIVE COMPARATOR

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

Interventions

Sitagliptin DRUG

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

low GLP-1 arm; normal GLP-1 arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are newly diagnosed of T2DM according to World Health Organisation criteria) and do not receive any glucose-lowering drugs
• Subjects who are willing to participate and sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Sultan Ismail

Johor Bahru, Johor, 81100, Malaysia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Kamaruddin Nor Azmi

  National University of Malaysia

  STUDY DIRECTOR

• Shiau Chin Chong

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 6, 2018
• Study Start: October 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

MY (1)