Type 2 Diabetes MellitusIBCT2NCT02026024
Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients
An observational study of Type 2 Diabetes Mellitus, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly controlled Type 2 diabetes patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Dec 2015
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Poorly Controlled Type 2 Diabetic Patients
Who may be able to join
- i) Age > 20 years old ii)DM (diabetes mellitus) diagnosed > 2 years iii)HbA1c level of 8% to 12% iv) Receiving incretin based therapy at least one month (including either GLP-1 agonist or DPP(dipeptidyl peptidase)-IV inhibitor
Who cannot join
- Type 1 Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Genetic Variations Study of Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients
Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly controlled Type 2 diabetes patients. This study is designed to understand the pharmacological effects and genetic variation of incretin based therapy on type 2 diabetes.
Read the detailed description
Background:
Since GLP-1 receptor is encoded by GLP1R ( glucagon-like peptide-1 receptor) gene, individuals may veritably respond to incretion based treatment, depending on the presence or absence of minor alleles characterized by single nucleotide polymorphisms. The genotyping of patients will be performed to compare the genetic factors and the pharmacological effects.
Expected Results: How to select a anti-diabetic drug tailored to the individual becomes more and more important because the enormously increasing classes of treatment modality. This study could be of great help in recommending the best possible agent for an individual, improving the possibility of treatment success, and justifying if the need of expensive drugs in a given patient.
- Conditions
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
mean amplitude of glycaemic excursions (MAGE)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2015
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHIA-HUNG LIN, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026024
- Sponsor's protocol ID
- 102-3596B
- Acronym
- IBCT2
- Status last verified
- Jan 2016
- First submitted
- 30 Dec 2013
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Genetic Variations Study of Incretin Based Therapy for Poorly Controlled Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02026024
- Acronym / sponsor ID
- IBCT2 / 102-3596B
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Jan 2014 (estimated)
- 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.
Type 2 diabetes patients have been proved to have decreased of glucagon-like peptide-1 (GLP-1) levels. Incretin based therapy is associated with improved glycemic control by boosting GLP-1 levels . Nevertheless, the clinical effects are in great diversity for poorly controlled Type 2 diabetes patients. This study is designed to understand the pharmacological effects and genetic variation of incretin based therapy on type 2 diabetes.
Detailed description
Background:
Since GLP-1 receptor is encoded by GLP1R ( glucagon-like peptide-1 receptor) gene, individuals may veritably respond to incretion based treatment, depending on the presence or absence of minor alleles characterized by single nucleotide polymorphisms. The genotyping of patients will be performed to compare the genetic factors and the pharmacological effects.
Expected Results: How to select a anti-diabetic drug tailored to the individual becomes more and more important because the enormously increasing classes of treatment modality. This study could be of great help in recommending the best possible agent for an individual, improving the possibility of treatment success, and justifying if the need of expensive drugs in a given patient.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Poorly Controlled Type 2 Diabetic Patients
Key inclusion criteria (1 listed)
- i) Age > 20 years old ii)DM (diabetes mellitus) diagnosed > 2 years iii)HbA1c level of 8% to 12% iv) Receiving incretin based therapy at least one month (including either GLP-1 agonist or DPP(dipeptidyl peptidase)-IV inhibitor
Key exclusion criteria (1 listed)
- Type 1 Diabetes Mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mean amplitude of glycaemic excursions (MAGE)
Time frame: 3 months
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 2 Feb 2016.
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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.
CHIA-HUNG LIN, M.D. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 2 Feb 2016. 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 Taiwan. 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?
mean amplitude of glycaemic excursions (MAGE) (time frame: 3 months). 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 2 Feb 2016.