Type 2 Diabetes MellitusPhase 4NCT04470310
Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination
A Phase 4 study testing Glimepiride, Alogliptin 25Mg Tab and Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet in people with Type 2 Diabetes Mellitus, run by Seoul National University Hospital.
Trial summary
This trial is a three-armed, open label, random assignment trial. The research subjects are patients who are first starting their treatment or patients who have failed with the metformin treatment and are changing their medication. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Glimepiride, Alogliptin 25Mg Tab and Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2015to 31 Aug 2021
- Phase
- Phase 4
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects selected for this trial will be male and female outpatients 19 - 80 years of age (by date of birth) with type 2 diabetes and with HbA1c levels of 7.5%≤HbA1c≤10%.
- Patient's body mass index must be greater than 18 kg/m2.
- Subjects selected for the trial are patients who are starting treatment for the first time or who have failed with more than 8 weeks of treatment with 1,000 mg or the maximum tolerance dose (MTD) of metformin and want to change their medication.
Who cannot join
- If weight loss pills were used in the last 3 months, or hypoglycemic agents or lipid lowering agents used in a clinical trial (not including statins or ezetimibe) were used in the last 3 months.
- If the subject received systemic corticosteroid treatment or there was a change in the dosage of thyroid hormones in the 6 weeks prior to the study.
- If insulin was used within the 3 months prior to screening.
- If the patient's C-peptide level is less than 0.6 ng/mL.
- If an allergy or a hypersensitivity reaction to the target drug or its ingredients occurs.
- Additional criteria for exclusion are listed below;
Show all 31Show fewer
- A medical history of type 1 diabetes; acute metabolic complications of diabetes within the past 6 months (e.g., ketoacidosis or a hyperosmolar state (coma or precoma))
- Hematological disorder
- A medical history of angioedema caused by angiotensin converting enzyme inhibitors or angiotensin receptor blockers or a medical history of treatment for diabetic gastroparesis
- If there are clear symptoms of hypothyroidism or hyperthyroidism in the opinion of the investigator.
- Myocardial infarction or percutaneous coronary intervention (stent nephrostomy or balloon nephrostomy) within the past 6 months
- Serious heart failure or a medical history of heart failure (NYHA Class III or IV heart failure)
- Heart failure, moderate to severe kidney injury (creatinine clearance of <50 mL/min prior to screening)
- Patients with chronic hepatitis, or hepatitis B or C (not including healthy carriers of hepatitis B) or a patient with liver disease (defined as cases in which the alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or serum total bilirubin level is higher than 2.5 times the ULN)
- Hereditary complications, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (restricted to drugs including lactase)
- Cardiovascular disease or myocardial infarction; or a percutaneous transluminal coronary angioplasty or coronary artery stent nephrostomy within the past 6 months
- A serious cerebrovascular accident, stroke, or transient ischemic attack within the past 6 months
- Laser treatment for diabetic proliferative retinopathy
- A medical history of alcohol or drug abuse in the past 3 months
- A medical history of cancer in which remission could not be achieved within 5 years
- A medical history of bladder cancer or active bladder cancer
- Uninvestigated macroscopic hematuria
- Has experienced major surgery
- Breast feeding women, pregnant women, or premenopausal for whom pregnancy is possible are not suitable for participation in this trial
- External injury, acute infection, existence of or medical history of other chronic illness
- Criteria for exclusion based on laboratory test results are as listed below.
- A fasting blood glucose (FPG) level of >239.6 mg/dL
- Systolic or diastolic blood pressure of >160 mmHg or >100 mmHg respectively
- A serum creatinine level of 1.5 mg/dL for men or 1.4 mg/dL for women
- An albumin/creatinine ratio of 2,000 mg/g
- A fasting triglyceride level of > 5.1 mmol/l (452 mg/dL)
About this study
Official title: Comparison of Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination in Poorly Controlled Type 2 Diabetic Patients
- This trial is a three-armed, open label, random assignment trial.
- The research subjects are patients who are first starting their treatment or patients who have failed with the metformin treatment and are changing their medication. They will be assigned to one of the following treatment groups: the glimepiride monotherapy treatment group, the alogliptin monotherapy treatment group, and the alogliptin - pioglitazone combination therapy treatment group
- This trial is a prospective trial which will conduct surveys 6 times over the course of the 6 months in which each treatment group is administered drugs (Week -2, Baseline, Week 4, Week 12, Week 24, follow-up safety survey).
- This trial is a multicenter clinical trial which will be conducted at more than 5 general hospital medical institutions in the vicinity of the capital.
Read the detailed description
- The research subjects selected for this trial will patients among those who have given their approval to participate in the trial and who are first starting their treatment or who intend to alter their medication because treatment with the existing drugs has failed who satisfy the criteria.
- Patients with a '7.5% ≤ HbA1c ≤ 10%' in the HbA1c test will be chosen.
- Patients who are intending to change drugs due to the failure of an existing drug treatment must have the use of 1,000 mg or the maximum tolerance dose (MTD) of metformin recorded in his or her medical records.
- The investigators must confirm the patient's intention to participate in the trial and, starting at the point of the routine laboratory test results, must provide a sufficient explanation of this research to the patients who satisfy the criteria and then must acquire a research subject consent form from these patients. The consent forms must include the trial objectives, the benefits for participants, the risk factors, a confidentiality agreement, the right to withdraw consent, and contact information. The patients must sign the consent forms.
- The change in the level of HbAc1 will be compared among the 3 treatment groups - the glimepiride monotherapy treatment group, the alogliptin monotherapy treatment group, and the alogliptin - pioglitazone combination therapy treatment group - until the 24th week after the Baseline is taken.
- CGMS will be checked to investigate changes in blood glucose.
- Glimepiride's nonproprietary name is glimepiride; this drug is a snowman shaped tablet. Starting with a 1 mg dosage once a day before the first meal, the investigators will decide to increase the dosage to a maximum of 2 mg in the Week 4.
- Dosage adjustment will be conducted for participants proven to have persistent hyperglycemia (in the opinion of the investigator).
Week 4 Week 12 Alogliptin 25mg Dosage adjustment is not allowed Dosage adjustment is not allowed Glimepiride1mg 2mg Dosage adjustment is not allowed Alogliptin 25mg
+Pioglitazone 15mg Dosage adjustment is not allowed Dosage adjustment is not allowed
- Alogliptin's nonproprietary name is alogliptin benzoate and is an oval-shaped yellow tablet. A 25 mg dose of this medication is administered once a day and is taken with food or on an empty stomach.
- The pioglitazone used by the alogliptin - pioglitazone combination therapy treatment group is pioglitazone hydrochloride and is a grey circular tablet. A 15 mg dose of this medication is administered once a day and is taken with food or on an empty stomach.
- The subjects will test the HbA1c level in Week 12 and Week 24 and will check CGMS at the Baseline and in Week 24.
- General characteristics (bodyweight and BMI), vital signs, and laboratory tests will be conducted in Week 4, Week 12, and Week 24.
- MAGE will be measured using CGMS (continuous glucose monitoring system) for 3 days (72 hours). Education regarding eating, CGMS usage, notices, and correction will be given.
- A follow-up safety survey will be conducted 30 days after the last visit.
- Subjects will be enrolled in the trial for 6 months and following this a follow-up survey will be conducted.
- Approximately 12 months will be required for the total trial period based on the last patient (6 months) to have their Baseline enrollment conducted.
- Patients will be asked to come to the clinical research institution after Week 4, Week 12, and Week 24 (for Week 12 and Week 24, a period of ±7 days is permitted) after the Baseline (or the first) visit. In addition, patients will be requested to take a call 30 days after their last visit for the safety follow-up survey.
- Subjects with a drug compliance of less than 80% will be eliminated.
- Subjects with an HbA1c level of more than 9.0% in Week 12 will be eliminated. Subjects who sign the trial subject consent form and participate in the trial but do not finish will be eliminated. The elimination of a subject can be determined at any time during the trial. Withdrawal of consent by the subject will also be considered as an elimination and the reason for the withdrawal of consent must be clearly recorded. Furthermore, if an adverse event and/or a serious adverse event occurs during the trial, the corresponding subject will be immediately eliminated from the trial.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Glimepiride, Alogliptin 25Mg Tab, Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlimepirideDrug
Alogliptin 25Mg TabDrug
Alogliptin-Pioglitazone 25 Mg-15 Mg Oral TabletDrug
| Study group | Role | What they receive |
|---|---|---|
| glimepiride | Active comparator | glimepiride 1mg monotherapy and glimepiride 2mg monotherapy Receives: Drug: Glimepiride |
| alogliptin | Active comparator | alogliptin 25mg monotherapy Receives: Drug: Alogliptin 25Mg Tab |
| alogliptin - pioglitazone | Active comparator | Alogliptin 25mg+pioglitazone 15mg combination Receives: Drug: Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The change in the mean level of HbA1c from baseline at week 24
Measured: Baseline, Week 24
Secondary outcomes (3)
HbA1c and fasting plasma glucose
The change in the mean level of HbA1c at week 12 and mean FPG( fasting plasma glucose) levels
Measured: Baseline, Week 12, Week 24
The change in parameters of glycemic variability assessed by CGM from the Baseline at week 24
The change in parameters of glycemic variability assessed by CGM from baseline at week 24: SD(standard deviation), MAGE(Mean Amplitude of Glycaemic Excursions); MODD(Mean of Daily Differences); ADDR(Average Daily Risk Range), M-value
Measured: Baseline, Week 24
The change in lipid profile from baseline at week 12 and 24
The average change in the lipid profile: Total cholesterol (mg/dL), Triglyceride(mg/dL), HDL-cholesterol, (mg/dL) LDL cholesterol (mg/dL)
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start31 Dec 2015
- Primary completion20 May 2019
- Study completion31 Aug 2021 (estimated)
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A (glimepiride), Group B (alogliptin), and Group C (alogliptin-pioglitazone)
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Hee Choi, Seoul National University Hospital
- Investigators
- Sung Hee Choi, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470310
- Sponsor's protocol ID
- Takeda_ALO-IIT
- Status last verified
- Oct 2020
- First submitted
- 1 Jul 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glimepiride, Alogliptin and Alogliptin+Pioglitazone Combination in Poorly Controlled Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04470310
- Acronym / sponsor ID
- Takeda_ALO-IIT
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 14 Jul 2020 (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 trial is a three-armed, open label, random assignment trial.
- The research subjects are patients who are first starting their treatment or patients who have failed with the metformin treatment and are changing their medication. They will be assigned to one of the following treatment groups: the glimepiride monotherapy treatment group, the alogliptin monotherapy treatment group, and the alogliptin - pioglitazone combination therapy treatment group
- This trial is a prospective trial which will conduct surveys 6 times over the course of the 6 months in which each treatment group is administered drugs (Week -2, Baseline, Week 4, Week 12, Week 24, follow-up safety survey).
- This trial is a multicenter clinical trial which will be conducted at more than 5 general hospital medical institutions in the vicinity of the capital.
Detailed description
- The research subjects selected for this trial will patients among those who have given their approval to participate in the trial and who are first starting their treatment or who intend to alter their medication because treatment with the existing drugs has failed who satisfy the criteria.
- Patients with a '7.5% ≤ HbA1c ≤ 10%' in the HbA1c test will be chosen.
- Patients who are intending to change drugs due to the failure of an existing drug treatment must have the use of 1,000 mg or the maximum tolerance dose (MTD) of metformin recorded in his or her medical records.
- The investigators must confirm the patient's intention to participate in the trial and, starting at the point of the routine laboratory test results, must provide a sufficient explanation of this research to the patients who satisfy the criteria and then must acquire a research subject consent form from these patients. The consent forms must include the trial objectives, the benefits for participants, the risk factors, a confidentiality agreement, the right to withdraw consent, and contact information. The patients must sign the consent forms.
- The change in the level of HbAc1 will be compared among the 3 treatment groups - the glimepiride monotherapy treatment group, the alogliptin monotherapy treatment group, and the alogliptin - pioglitazone combination therapy treatment group - until the 24th week after the Baseline is taken.
- CGMS will be checked to investigate changes in blood glucose.
- Glimepiride's nonproprietary name is glimepiride; this drug is a snowman shaped tablet. Starting with a 1 mg dosage once a day before the first meal, the investigators will decide to increase the dosage to a maximum of 2 mg in the Week 4.
- Dosage adjustment will be conducted for participants proven to have persistent hyperglycemia (in the opinion of the investigator).
Week 4 Week 12 Alogliptin 25mg Dosage adjustment is not allowed Dosage adjustment is not allowed Glimepiride1mg 2mg Dosage adjustment is not allowed Alogliptin 25mg
+Pioglitazone 15mg Dosage adjustment is not allowed Dosage adjustment is not allowed
- Alogliptin's nonproprietary name is alogliptin benzoate and is an oval-shaped yellow tablet. A 25 mg dose of this medication is administered once a day and is taken with food or on an empty stomach.
- The pioglitazone used by the alogliptin - pioglitazone combination therapy treatment group is pioglitazone hydrochloride and is a grey circular tablet. A 15 mg dose of this medication is administered once a day and is taken with food or on an empty stomach.
- The subjects will test the HbA1c level in Week 12 and Week 24 and will check CGMS at the Baseline and in Week 24.
- General characteristics (bodyweight and BMI), vital signs, and laboratory tests will be conducted in Week 4, Week 12, and Week 24.
- MAGE will be measured using CGMS (continuous glucose monitoring system) for 3 days (72 hours). Education regarding eating, CGMS usage, notices, and correction will be given.
- A follow-up safety survey will be conducted 30 days after the last visit.
- Subjects will be enrolled in the trial for 6 months and following this a follow-up survey will be conducted.
- Approximately 12 months will be required for the total trial period based on the last patient (6 months) to have their Baseline enrollment conducted.
- Patients will be asked to come to the clinical research institution after Week 4, Week 12, and Week 24 (for Week 12 and Week 24, a period of ±7 days is permitted) after the Baseline (or the first) visit. In addition, patients will be requested to take a call 30 days after their last visit for the safety follow-up survey.
- Subjects with a drug compliance of less than 80% will be eliminated.
- Subjects with an HbA1c level of more than 9.0% in Week 12 will be eliminated. Subjects who sign the trial subject consent form and participate in the trial but do not finish will be eliminated. The elimination of a subject can be determined at any time during the trial. Withdrawal of consent by the subject will also be considered as an elimination and the reason for the withdrawal of consent must be clearly recorded. Furthermore, if an adverse event and/or a serious adverse event occurs during the trial, the corresponding subject will be immediately eliminated from the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group A (glimepiride), Group B (alogliptin), and Group C (alogliptin-pioglitazone)
| Arm | Type | Receives |
|---|---|---|
| glimepiride | Active comparator | Drug: Glimepirideglimepiride 1mg monotherapy and glimepiride 2mg monotherapy |
| alogliptin | Active comparator | Drug: Alogliptin 25Mg Tabalogliptin 25mg monotherapy |
| alogliptin - pioglitazone | Active comparator | Drug: Alogliptin-Pioglitazone 25 Mg-15 Mg Oral TabletAlogliptin 25mg+pioglitazone 15mg combination |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects selected for this trial will be male and female outpatients 19 - 80 years of age (by date of birth) with type 2 diabetes and with HbA1c levels of 7.5%≤HbA1c≤10%.
- Patient's body mass index must be greater than 18 kg/m2.
- Subjects selected for the trial are patients who are starting treatment for the first time or who have failed with more than 8 weeks of treatment with 1,000 mg or the maximum tolerance dose (MTD) of metformin and want to change their medication.
Key exclusion criteria (31 listed)
- If weight loss pills were used in the last 3 months, or hypoglycemic agents or lipid lowering agents used in a clinical trial (not including statins or ezetimibe) were used in the last 3 months.
- If the subject received systemic corticosteroid treatment or there was a change in the dosage of thyroid hormones in the 6 weeks prior to the study.
- If insulin was used within the 3 months prior to screening.
- If the patient's C-peptide level is less than 0.6 ng/mL.
- If an allergy or a hypersensitivity reaction to the target drug or its ingredients occurs.
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 |
|---|---|---|
| Glimepiride | Drug | glimepiride |
| Alogliptin 25Mg Tab | Drug | alogliptin |
| Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet | Drug | alogliptin - pioglitazone |
Primary outcome
HbA1c
Time frame: Baseline, Week 24
The change in the mean level of HbA1c from baseline at week 24
3 secondary outcomes
HbA1c and fasting plasma glucose
Time frame: Baseline, Week 12, Week 24
The change in parameters of glycemic variability assessed by CGM from the Baseline at week 24
Time frame: Baseline, Week 24
The change in lipid profile from baseline at week 12 and 24
Time frame: Baseline, Week 12, Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
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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.
Sung Hee Choi principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glimepiride, Alogliptin 25Mg Tab and Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet in people with Type 2 Diabetes Mellitus, run by Seoul National University Hospital.
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 31 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
HbA1c (time frame: Baseline, Week 24). 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 22 Oct 2020.