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CompletedNCT03659461GLP-1Updated Mar 15, 2022

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

An interventional study of Sitagliptin in Type 2 Diabetes Mellitus and PreDiabetes, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-15.

Sponsored by National University of Malaysia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2017, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • PreDiabetes
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 174 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

National University of Malaysia is the lead sponsor of 119 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
174 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugSitagliptin

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

06

What researchers measure

Primary outcomes

  1. change in blood glucose load response to sitagliptin

    change from blood glucose response at 12 weeks

    Time frame: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin

  2. change in blood insulin response to sitagliptin

    change from blood insulin response at 12 weeks

    Time frame: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin

07

Study locations

1 site
  • Hospital Sultan Ismail
    Johor Bahru, Johor 81100, Malaysia
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03659461
Lead sponsor
National University of Malaysia
Responsible party
Chong Shiau Chin (Pharmacist, National University of Malaysia) — Principal investigator
First posted
Sep 6, 2018
Start date
Oct 1, 2017
Primary completion
Dec 31, 2019
Completion
Jan 31, 2020
Last update
Mar 15, 2022

Study contacts

Kamaruddin Nor Azmi
study director · National University of Malaysia
Shiau Chin Chong
principal investigator · National University of Malaysia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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