Type 2 Diabetes MellitusGLP-1NCT03659461
Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus
A study testing Sitagliptin in people with Type 2 Diabetes Mellitus and PreDiabetes, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, PreDiabetes
- What is being tested?
- Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2017to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type 2 Diabetes Mellitus, PreDiabetes
- Being tested
- Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in blood glucose load response to sitagliptin
change from blood glucose response at 12 weeks
Measured: 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
Measured: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Oct 2017
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Shiau Chin, National University of Malaysia
- Investigators
- Kamaruddin Nor Azmi, Study director, National University of MalaysiaShiau Chin Chong, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659461
- Sponsor's protocol ID
- UKM-22
- Acronym
- GLP-1
- Status last verified
- Mar 2022
- First submitted
- 29 Aug 2018
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Incretin System in Three Ethnic Groups With Abnormal Glucose Tolerance
- ClinicalTrials.gov ID
- NCT03659461
- Acronym / sponsor ID
- GLP-1 / UKM-22
- Conditions
- Type 2 Diabetes Mellitus, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low GLP-1 arm | Experimental | Drug: SitagliptinSubjects 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 |
| normal GLP-1 arm | Active comparator | Drug: SitagliptinSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitagliptinoral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment. | Drug | low GLP-1 arm, normal GLP-1 arm |
Primary outcome
change in blood glucose load response to sitagliptin
Time frame: 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
Time frame: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin
change from blood insulin response at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamaruddin Nor Azmi study director
National University of Malaysia
Shiau Chin Chong principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitagliptin in people with Type 2 Diabetes Mellitus and PreDiabetes, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in blood glucose load response to sitagliptin (time frame: pre-treatment of sitagliptin and post 12-week treatment of sitagliptin). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.