Diabetes Mellitus, Type 2Phase 1NCT03646721
A Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM
A Phase 1 study testing DA-1241 and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Dong-A ST Co., Ltd. at 4 sites in United States.
Trial summary
This is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, PK and PD of DA-1241 in healthy male subjects and subjects with T2DM Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- DA-1241 and Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Aug 2018to 7 May 2020
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects
- Age ≥ 18 to ≤ 70 years of age.
- Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2.
- Non-diabetic, fasting plasma glucose (FPG) of < 100 mg/dL (measured with YSI at site; one repeat test is allowed)
- HbA1c < 5.7 %
- Non-smoker smoker, defined as: Non-smoker for >12 months (ie, subject has not smoked or used any tobacco product for the 12 months prior to the start of the study) confirmed by a negative nicotine/cotinine test.
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- Male subjects must be surgically sterile, or engaged with partners of non-childbearing potential, or if engaged with partners of childbearing potential, the subject and his partner must be willing to use contraceptive methods until 3 months after the last day of IP administration. Males must not donate sperms during the study and until 3 months after the last day of IP administration.
- Upon review, agree to participate and sign informed consent
- Male and female subjects with T2DM > 6 months.
- Age ≥ 18 to ≤ 70 years of age.
- Body mass index (BMI) ≤ 35 kg/m2.
- On stable therapy with metformin monotherapy or metformin in combination with other oral antidiabetic drugs (OADs) ≥ 1 month. (OADs except metformin will be washed-out prior to the first dosing)
- HbA1c ≥ 6.5 to ≤ 10%
- Female and male subjects must agree to use highly effective methods of birth control until 120 days after the last day of IP administration, or must be surgically sterile or postmenopausal. Males must not donate sperm during the study and until 120 days after the last day of IP administration.
- Upon review, agree to participate and sign informed consent.
Who cannot join
- Resting blood pressure (BP) > 140/90 mmHg or < 90/60 mmHg. Subjects BP may be re-checked.
- Participation in an investigational drug/device study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.
- History of any serious adverse reaction or hypersensitivity to any of the investigational product components or medicinal products with similar chemical structure.
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the investigator, would unduly risk the subject's safety or may impact the conduct of the study.
- History of or acute significant gastrointestinal disorder (eg, peptic ulcers, severe GERD), gastric surgery, including surgical treatment for obesity (eg, bariatric surgery, gastric banding), gastric bypass or antrectomy or small bowel resection >20cm or any disorder that would interfere with the swallowing, absorption, distribution, metabolism and excretion of the investigational product. Surgery for appendicitis is acceptable.
- Subject shows evidence of significant active neuropsychiatric disease, including taking prescription medication for such diseases (including anti-depressant /anti-anxiety medication),
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- Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject. (Laboratory results may be re-checked once on a separate day per Investigator discretion)
- Long QT syndrome or family history of long QT syndrome or corrected QT interval (QTcF) > 450 ms at screening.
- Liver function test results of AST and/or ALT ≥ 1.5 upper limit of normal (ULN).
- Subject had a history of vaso-vagal syncope within 5 years.
- History of any major surgery within 6 months.
- History of any active infection, other than mild viral illness within 30 days prior to dosing.
- Known history or positive test of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody.
- Subjects with a positive urine nicotine/cotinine dipstick test.
- History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake > 21 units/week or are unwilling to stop alcohol consumption from 24 hours prior to each dosing until discharged from the clinical research unit (CRU). Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, 100 mL of wine, or 35 mL of spirits).
- History of illicit drug abuse, within approximately 1 year or evidence of current use as judged by the Investigator. Positive drug test, including marijuana, at Screening.
- Donation or loss of > 500 mL of blood within 56 days.
- Chronic use of over-the-counter or prescription medication within 7 or 14 days prior to dosing per Investigator's discretion (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
- Unable to comply with the safety monitoring requirements of this clinical study or is considered by the investigator to be an unsuitable candidate for the study.
- <Part 2>
- A subject who has acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, especially autonomic neuropathy, as judged by the Investigator.
- Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis, as judged by the Investigator.
- Persistent blood pressure (BP) systolic or diastolic > 160/90 mmHg or < 90/60 mmHg. Subjects BP may be re-checked per site SOP. Treatment with stable doses of antihypertensive medication for 2 months prior to screening are allowed.
- Pregnant or lactating women.
- Participation in an investigational drug/device study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.
- History of any serious adverse reaction or hypersensitivity to any of the investigational product components or medicinal products with similar chemical structure.
- Current use of any prescribed or non-prescribed drugs (other than current treatment for diabetes mellitus or birth control methods) that are known to interfere with glucose or insulin metabolism, including but not limited to oral corticosteroids, GLP-1 receptor agonists, monoamine oxidase (MAO) inhibitors, growth hormone, non-selective β-blockers and lipid lowering medication. Lipid lowering medications will be washed-out prior to the first dosing if subjects take medication for primary prevention.
- History of administration or current use of thiazolidinediones (TZDs).
- Chronic use of acetaminophen, as acetaminophen is not allowed during the CGMS periods in the study.
- Unable to tolerate tape adhesive in the area of sensor placement.
- Subject has any unresolved adverse skin condition in the area of sensor placement (eg, psoriasis, rash, Staphylococcus infection).
- History of or acute significant gastrointestinal disorder (eg, peptic ulcers, severe GERD), gastric surgery, gastric bypass or antrectomy or small bowel resection or any disorder that would interfere with the swallowing, absorption, distribution, metabolism and excretion of the investigational product. Surgery for appendicitis is acceptable.
- History of renal disease or abnormal kidney function tests at Screening (eGFR < 60 mL/min/1.73m2 as estimated using the MDRD equation).
- Clinically significant abnormal laboratory test, in particular, elevated liver enzymes (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2 times the upper limit of normal (ULN)). (Laboratory results may be re-checked once on a separate day per Investigator discretion)
- Any history of heart disease, defined as symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, coronary artery bypass graft surgery, or angioplasty, unstable angina requiring medication, transient ischemic attack, cerebral infarct, or cerebral hemorrhage.
- History of any clinically or active significant gastrointestinal, cardiovascular, hematological, psychiatric, renal, hepatic, pancreatic or neurological abnormality that could interfere with the safety or results of this study as judged by the Investigator.
- Subject shows evidence of significant active neuropsychiatric disease. Subjects that are stable and controlled by stable doses of selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), antipsychotics and lithium for ≥ 6 months prior to screening are allowed.
- Presence of clinically significant physical or ECG findings (eg, QTcF > 450 msec for males, QTcF > 470 msec for females, left bundle branch block (LBBB)) at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results, or may present a safety issue to that particular subject.
- History of any major surgery within 6 months.
- History of any active infection, other than mild viral illness within 30 days prior to the first dosing.
- Known history or positive test of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus type 1 (HIV-1) or 2 (HIV-2) antibody.
- Smoking > 10 cigarettes per day or equivalent use of any tobacco product (eg, nicotine patch) within 6 months prior to Screening. Subjects must be able to refrain from smoking during each in-house period.
- History of alcohol abuse as judged by the Investigator within approximately 1 year. Average weekly alcohol intake > 21 units/week (males) and > 14 units/week (females) or are unwilling to stop alcohol consumption from 24 hours prior to each check-in for in-house and outpatient visits and throughout the in-house periods until discharged from the clinical research unit (CRU) and are unwilling to limit alcohol consumption during outpatient periods. Positive alcohol test at Screening. (One unit of alcohol equals about 250 mL of beer or lager, 100 mL of wine, or 35 mL of spirits).
- History of illicit drug abuse, within approximately 1 year or evidence of current use as judged by the Investigator. Positive drug test, including marijuana, at Screening.
- Donation or loss of > 500 mL of blood within 56 days.
- Unable to comply with the safety monitoring requirements of this clinical study or is considered by the investigator to be an unsuitable candidate for the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Clinical Site
Chula Vista, California, 91911
High Point Clinical Trials Center
High Point, North Carolina, 27265
Clinical Pharmacology of Miami
Miami, Florida, 33014
Rainier Clinical Research Center
Renton, Washington, 98057
About this study
Official title: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM
This is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, PK and PD of DA-1241 in healthy male subjects and subjects with T2DM
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- DA-1241, Placebo, Sitagliptin
- 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.
DA-1241Drug
[Part1] Administration once daily for 28 days; Dose strength for each cohort (Cohort 1, 2 and 3) is planned as 50mg, 100mg and 200mg, respectively.
[Part2] Administration once daily for 56 days; Dose strength for each cohort (Cohort 4, 5 and 6) is planned as 25mg, 50mg and 100mg, respectively.
(Dose escalation and dose level decisions for subsequent cohorts will be made via interim dose escalation review meetings.)
PlaceboDrug
[Part1] Administration once daily for 28 days. [Part2] Administration once daily for 56 days.
SitagliptinDrug
[Part2] Administration of Sitagliptin 100mg once daily for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| [Part1] DA-1241 : 6 subjects in each cohort(Cohort 1-3) | Experimental | Subjects will participate in 1 of 3 cohorts consisting of 8 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 6:2 (DA-1241 to matching placebo). Receives: Drug: DA-1241 |
| [Part1] Placebo : 2 subjects in each cohort(Cohort 1-3) | Placebo comparator | Subjects will participate in 1 of 3 cohorts consisting of 8 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 6:2 (DA-1241 to matching placebo). Receives: Drug: Placebo |
| [Part2] DA-1241 : 15 subjects in each cohort(Cohort 4-6) | Experimental | Subjects will participate in 1 of 3 cohorts consisting of 25 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 3:1:1 (DA-1241 to matching placebo and active comparator). Receives: Drug: DA-1241 |
| [Part2] Placebo : 5 subjects in each cohort(Cohort 4-6) | Placebo comparator | Subjects will participate in 1 of 3 cohorts consisting of 25 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 3:1:1 (DA-1241 to matching placebo and active comparator). Receives: Drug: Placebo |
| [Part2] Sitagliptin : 5 subjects in each cohort(Cohort 4-6) | Active comparator | Subjects will participate in 1 of 3 cohorts consisting of 25 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 3:1:1 (DA-1241 to matching placebo and active comparator). Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-lead ECGs
Change from baseline in QTcF (msec)
Measured: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Blood pressure
Change from baseline in blood pressure (mmHg)
Measured: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Heart rate
Change from baseline in heart rate (bpm)
Measured: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Body temperature
Change from baseline in oral body temperature (°C)
Measured: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Respiratory rate
Change from baseline in respiratory rate (bpm)
Measured: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Physical examination
Incidence and severity of clinical findings on physical examination
Measured: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Clinical laboratory testing
Incidence and severity of clinical laboratory abnormality
Measured: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Adverse event
Incidence and severity of adverse event
Measured: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Secondary outcomes (21)
Maximum concentration of DA-1241 (Cmax)
Measured: Through the treatment period; 24 hours
Time of maximum plasma DA-1241 concentration (Tmax)
Measured: Through the treatment period; 24 hours
Area under the concentration-time curve (AUC)
Measured: Through the treatment period; 9 days
Apparent terminal elimination half-life (t½)
Measured: Through the treatment period; 9 days
Apparent total systemic clearance after oral administration (CL/F)
Measured: Through the treatment period; 9 days
Apparent volume of distribution (Vz/F)
Measured: Through the treatment period; 9 days
Accumulation ratio (Last dosing day AUCtau / First dosing day AUCtau)
Measured: Through the treatment period; 9 days
Amount of DA-1241 excreted unchanged in the urine in each collection interval(Ae)
Measured: Through the treatment period; 7 days
Cumulative amount of DA-1241 excreted unchanged in the urine (Cum Ae)
Measured: Through the treatment period; 7 days
Percentage fraction of DA-1241 excreted unchanged in the urine in each collection interval(Fe)
Measured: Through the treatment period; 7 days
Cumulative percentage fraction of DA-1241 excreted unchanged in the urine (Cum Fe)
Measured: Through the treatment period; 7 days
Renal clearance (CLR)
Measured: Through the treatment period; 7 days
Fasting Plasma Glucose (FPG)
Measured: Through the treatment period; 62 days
2h-Postprandial glucose
Measured: Through the treatment period; 56 days
Area under the measurements versus (vs) time curve(AUE)
Measured: Through the treatment period; 56 days
Incremental AUEs after meal (iAUE)
Measured: Through the treatment period; 56 days
Weighted mean glucose (WMG)
Measured: Through the treatment period; 56 days
Incremental WMG (iWMG)
Measured: Through the treatment period; 56 days
Fasting Insulin
Measured: Through the treatment period; 56 days
Glycated albumin
Measured: Through the treatment period; 56 days
HbA1c
Measured: Through the treatment period; 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start29 Aug 2018
- Primary completion7 May 2020
- Study completion7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646721
- Sponsor's protocol ID
- DA1241_DM_Ib
- Status last verified
- Feb 2021
- First submitted
- 21 Aug 2018
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, PK and PD of DA-1241 in Healthy Male Subjects and Subjects With T2DM
- ClinicalTrials.gov ID
- NCT03646721
- Acronym / sponsor ID
- DA1241_DM_Ib
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 24 Aug 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 is a double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, PK and PD of DA-1241 in healthy male subjects and subjects with T2DM
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| [Part1] DA-1241 : 6 subjects in each cohort(Cohort 1-3) | Experimental | Drug: DA-1241Subjects will participate in 1 of 3 cohorts consisting of 8 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 6:2 (DA-1241 to matching placebo). |
| [Part1] Placebo : 2 subjects in each cohort(Cohort 1-3) | Placebo comparator | Drug: PlaceboSubjects will participate in 1 of 3 cohorts consisting of 8 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 6:2 (DA-1241 to matching placebo). |
| [Part2] DA-1241 : 15 subjects in each cohort(Cohort 4-6) | Experimental | Drug: DA-1241Subjects will participate in 1 of 3 cohorts consisting of 25 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 3:1:1 (DA-1241 to matching placebo and active comparator). |
| [Part2] Placebo : 5 subjects in each cohort(Cohort 4-6) | Placebo comparator | Drug: PlaceboSubjects will participate in 1 of 3 cohorts consisting of 25 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 3:1:1 (DA-1241 to matching placebo and active comparator). |
| [Part2] Sitagliptin : 5 subjects in each cohort(Cohort 4-6) | Active comparator | Drug: SitagliptinSubjects will participate in 1 of 3 cohorts consisting of 25 subjects per cohort. Within cohorts, subjects will be randomized to a ratio of 3:1:1 (DA-1241 to matching placebo and active comparator). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy male subjects
- Age ≥ 18 to ≤ 70 years of age.
- Body mass index (BMI) ≥ 18.5 to ≤ 29.9 kg/m2.
- Non-diabetic, fasting plasma glucose (FPG) of < 100 mg/dL (measured with YSI at site; one repeat test is allowed)
- HbA1c < 5.7 %
Key exclusion criteria (46 listed)
- Resting blood pressure (BP) > 140/90 mmHg or < 90/60 mmHg. Subjects BP may be re-checked.
- Participation in an investigational drug/device study within 30 days or 5 half-lives within the last dose of any study drug, whichever is longer.
- History of any serious adverse reaction or hypersensitivity to any of the investigational product components or medicinal products with similar chemical structure.
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders or abnormalities, or other major systemic disease that, according to the investigator, would unduly risk the subject's safety or may impact the conduct of the study.
- History of or acute significant gastrointestinal disorder (eg, peptic ulcers, severe GERD), gastric surgery, including surgical treatment for obesity (eg, bariatric surgery, gastric banding), gastric bypass or antrectomy or small bowel resection >20cm or any disorder that would interfere with the swallowing, absorption, distribution, metabolism and excretion of the investigational product. Surgery for appendicitis is acceptable.
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 |
|---|---|---|
| DA-1241[Part1] Administration once daily for 28 days; Dose strength for each cohort (Cohort 1, 2 and 3) is planned as 50mg, 100mg and 200mg, respectively. [Part2] Administration once daily for 56 days; Dose strength for each cohort (Cohort 4, 5 and 6) is planned as 25mg, 50mg and 100mg, respectively. (Dose escalation and dose level decisions for subsequent cohorts will be made via interim dose escalation review meetings.) | Drug | [Part1] DA-1241 : 6 subjects in each cohort(Cohort 1-3), [Part2] DA-1241 : 15 subjects in each cohort(Cohort 4-6) |
| Placebo[Part1] Administration once daily for 28 days. [Part2] Administration once daily for 56 days. | Drug | [Part1] Placebo : 2 subjects in each cohort(Cohort 1-3), [Part2] Placebo : 5 subjects in each cohort(Cohort 4-6) |
| Sitagliptin[Part2] Administration of Sitagliptin 100mg once daily for 56 days. | Drug | [Part2] Sitagliptin : 5 subjects in each cohort(Cohort 4-6) |
Primary outcome
12-lead ECGs
Time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Change from baseline in QTcF (msec)
Blood pressure
Time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Change from baseline in blood pressure (mmHg)
Heart rate
Time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Change from baseline in heart rate (bpm)
Body temperature
Time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Change from baseline in oral body temperature (°C)
Respiratory rate
Time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Change from baseline in respiratory rate (bpm)
Physical examination
Time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Incidence and severity of clinical findings on physical examination
Clinical laboratory testing
Time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Incidence and severity of clinical laboratory abnormality
Adverse event
Time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively
Incidence and severity of adverse event
21 secondary outcomes
Maximum concentration of DA-1241 (Cmax)
Time frame: Through the treatment period; 24 hours
Time of maximum plasma DA-1241 concentration (Tmax)
Time frame: Through the treatment period; 24 hours
Area under the concentration-time curve (AUC)
Time frame: Through the treatment period; 9 days
Apparent terminal elimination half-life (t½)
Time frame: Through the treatment period; 9 days
Apparent total systemic clearance after oral administration (CL/F)
Time frame: Through the treatment period; 9 days
Apparent volume of distribution (Vz/F)
Time frame: Through the treatment period; 9 days
Accumulation ratio (Last dosing day AUCtau / First dosing day AUCtau)
Time frame: Through the treatment period; 9 days
Amount of DA-1241 excreted unchanged in the urine in each collection interval(Ae)
Time frame: Through the treatment period; 7 days
Cumulative amount of DA-1241 excreted unchanged in the urine (Cum Ae)
Time frame: Through the treatment period; 7 days
Percentage fraction of DA-1241 excreted unchanged in the urine in each collection interval(Fe)
Time frame: Through the treatment period; 7 days
Cumulative percentage fraction of DA-1241 excreted unchanged in the urine (Cum Fe)
Time frame: Through the treatment period; 7 days
Renal clearance (CLR)
Time frame: Through the treatment period; 7 days
Fasting Plasma Glucose (FPG)
Time frame: Through the treatment period; 62 days
2h-Postprandial glucose
Time frame: Through the treatment period; 56 days
Area under the measurements versus (vs) time curve(AUE)
Time frame: Through the treatment period; 56 days
Incremental AUEs after meal (iAUE)
Time frame: Through the treatment period; 56 days
Weighted mean glucose (WMG)
Time frame: Through the treatment period; 56 days
Incremental WMG (iWMG)
Time frame: Through the treatment period; 56 days
Fasting Insulin
Time frame: Through the treatment period; 56 days
Glycated albumin
Time frame: Through the treatment period; 56 days
HbA1c
Time frame: Through the treatment period; 56 days
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 11 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-1241 and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Dong-A ST Co., Ltd. at 4 sites in United States.
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 15 inclusion and 46 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
12-lead ECGs (time frame: Throughout study duration, i.e., about 10 weeks (Part1) and about 14-16 weeks (Part2), respectively). The study lists 8 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 11 Feb 2021.