Type 2 DiabetesPhase 1NCT04982705
IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics
A Phase 1 study testing [Part 1.1] IDG-16177, [Part 2] Sitagliptin and [Part1.2] IDG-16177 in people with Type 2 Diabetes, run by IlDong Pharmaceutical Co Ltd at 1 site in Germany.
Trial summary
This is a Phase I, first-in-human, randomised, double-blinded, placebo-and active-controlled study to assess the safety, tolerability, PK, PD, efficacy, and food-effect of IDG-16177 in healthy male subjects and patients with T2DM at different dose levels. Read more about this study
- Who is it for?
- Ages 19 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- [Part 1.1] IDG-16177, [Part 2] Sitagliptin and [Part1.2] IDG-16177
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jul 2021to 30 Dec 2022
- 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 19 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- [Part 1 and Part 2] Subjects/Patients who meet the following criteria will be considered eligible to participate in Part 1 or Part 2 of the clinical study:
- 1. Subject voluntarily/Patient agrees to participate in this study and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures. 2. Subject/Patient is able to understand the nature of the clinical study. 3. Subject/Patient is able to read and speak German. 4. Subject/Patient is able to communicate satisfactorily with the Investigator and study team and follow the entire requirements of the clinical study. [Part 1] Subjects who meet the following criteria will be considered eligible to participate in Part 1 of the clinical study:
- Healthy male subjects aged 19 to 55 years at the time of Screening.
- Subject weighs at least 60 kg and has a body mass index (BMI)between 18.5 and 29.9 kg/m2, inclusive, at Screening.
- Subject who is healthy and judged to be eligible to participate in the study at the Screening test (based on medical history, physical examination, vital sign, 12 lead ECG, and laboratory test including serology test).
- [Part 2] Patients who meet the following criteria will be considered eligible to participate in Part 2 of the clinical study:
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- Male patients aged 18 to 70 years at the time of Screening.
- Patient with T2DM who is taking metformin monotherapy as their only anti hyperglycemic treatment. Metformin dose must be stable, defined as no change in the treatment, including dose, for at least 2 months prior to the screening visit.
- Has a HbA1c level at Screening between 7.5% and 10.0%.
- Has a fasting plasma glucose level less than 13.3 mmol/L at Screening.
- Has a fasting C-peptide concentration greater than or equal to 0.8 ng/mL at Screening.
- If patient takes any chronic medications, the dose of these medications must have been stable (no change in dose or drug) for at least 4 weeks prior to Screening.
- Is able and willing to monitor glucose with a home glucose monitor and consistently record his blood glucose concentrations.
- Patient weighs at least 60 kg and has a BMI between 18.5 and 35 kg/m2, inclusive, at Screening.
Who cannot join
- [Part 1 and Part 2] Subjects/Patients who meet one or more of the following criteria will not be considered eligible to participate in Part 1 or Part 2 of the clinical study:
- Subject/Patient is an employee or a family member of the Sponsor or the involved CRO.
- Vulnerable subject (i.e., persons under any administrative or legal supervision or persons kept in detention).
- Subject/Patient who has a positive reverse transcription polymerase chain reaction (RT PCR) test for SARS-CoV-2 prior to randomisation.
- Subject/Patient who has clinical signs and symptoms consistent with SARS-CoV-2 infection; eg, fever, dry cough, dyspnea, sore throat, fatigue, or positive SARS-CoV-2 test result within 2 weeks prior to Screening.
- Subject/patient who had a severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated).
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- Recent (within previous 14 days) exposure to someone who has COVID-19 symptoms or positive test result.
- Subject who has currently acute disease with active symptoms.
- History of clinically significant hypersensitivity reaction to any drugs or additives.
- Subjects who have a history of any gastrointestinal disease (Crohn's disease, ulcerative colitis, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or herniotomy) which can affect the absorption of drugs.
- Subject who has participated in a clinical trial or bioequivalence test and have been administered in a product within 60 days or within 5 halflives of the drug, whichever is longer before the first study drug administration.
- Subject who have taken inducer or suppressor of metabolic enzymes such as barbiturates in 30 days before the first study drug administration.
- Subject who have donated whole blood in 60 days or who have donated plasma in 20 days before the first study drug administration.
- Subjects who have had any prescribed medicine or herbal medicine or who have had non-prescription medicine or vitamins within 7 days or 5 half lives before the first study drug administration, whichever is longer, except for occasional intake of paracetamol. Subjects who have received a SARS-CoV-2 vaccination within 4 weeks prior to screening or plan to be vaccinated during the study.
- Has a history of drug abuse or a history of alcohol abuse within 2 years prior to Screening.
- Subject who do not agree to be sexually abstinent or to use a condom with spermicide when engaging in sexual activity and to not donate sperm from the first administration of study drug, during the study, and for 14 days following completion of the study (Section 5.4.4).
- Subject who is judged to be not eligible by the Investigator for any other reason.
- Has a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV).
- Has a total bilirubin > 1.5 × ULN at Screening.
- Has abnormal thyroid-stimulating hormone levels. [Part 1] Subjects who meet one or more of the following criteria will not be considered eligible to participate in Part 1 of the clinical study:
- Subject who has abnormal vital signs, confirmed by repeat measurement at screening:
- systolic blood pressure (SBP) outside 90 - 139 mmHg
- diastolic blood pressure (DBP) outside 50 - 89 mmHg
- pulse rate outside 50 - 90 bpm.
- Abnormal 12-lead ECG, confirmed by repeat measurement, unless considered not clinically significant by Investigator. QTcF > 450 ms, QRS ≥ 120 ms, PR > 220 ms at Screening.
- Has an estimating glomerular filtration rate (eGFR) less than or equal to 80 mL/min using the chronic kidney disease epidemiology collaboration (CKD EPI) at Screening.
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, haematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease or any other condition. [Part 2] Patients who meet one or more of the following criteria will not be considered eligible to participate in Part 2 of clinical study:
- Has systolic blood pressure (BP) greater than 160 mm Hg or diastolic pressure greater than 100 mm Hg at Screening or baseline, confirmed by repeat measurement.
- Has history of cancer. A history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is allowed.
- Has a creatine phosphokinase level ≥ 5 × upper limit of normal (ULN) at Screening.
- Has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≥ 2 × ULN at Screening, confirmed by repeat measurement.
- Has a haemoglobin level ≤ lower limit normal (LLN) for men of the local laboratory at Screening, confirmed by repeat measurement.
- The subject has a serum triglyceride level ≥ 1.5 × ULN at Screening.
- Has an eGFR less than or equal to 60 mL/min using the CKD EPI at Screening.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Parexel International GmbH Early Phase Clinical Unit Klinikum Westend
Berlin, 14050
+49 30 30685 382
Rainard Fuhr
About this study
Official title: A Placebo- and Active-controlled, Randomised, Double-blind, Dose-escalation Phase I Study of IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics With the Exploration on Its Pharmacodynamics and Efficacy
This is a Phase I, first-in-human, randomised, double-blinded, placebo-and active-controlled study to assess the safety, tolerability, PK, PD, efficacy, and food-effect of IDG-16177 in healthy male subjects and patients with T2DM at different dose levels.
Read the detailed description
This study consists of 2 parts: Part 1 is a dose-escalation study in healthy male subjects in single ascending dose (SAD) (Part 1.1) including food-effect and multiple ascending dose (MAD) (Part 1.2) cohorts to determine the highest allowable dose (HAD) for patients with T2DM; and Part 2 is a placebo- and active-controlled efficacy exploration in patients with T2DM, insufficiently controlled with metformin alone.
- Conditions
- Type 2 Diabetes
- Being tested
- [Part 1.1] IDG-16177, [Part 1.1] Placebo of IDG-16177, [Part 2] Sitagliptin, [Part1.2] IDG-16177, [Part 2] IDG-16177
- Keywords
- T2DM
- 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.
[Part 1.1] IDG-16177Drug
[Part 1.1] Subjects will receive a single oral dose of IMP. Dose strenght for each cohort (Cohort 1-5) is planned as 0.5, 1, 2, 5, 10mg, respectively.
[Part 1.1] Placebo of IDG-16177Drug
[Part 1.1] subjects will receive a single oral dose of IMP.
[Part 2] SitagliptinDrug
Administration of Sitagliptin 100mg once daily for 4 weeks.
[Part1.2] IDG-16177Drug
[Part 1.2] Administration once daily for 14 days; Dose strenght for each cohort (Cohort 6-8) is planned as ≤ 2, ≤ 4, ≤ 8mg, respectively.
[Part 2] IDG-16177Drug
[Part 2] Administration once daily for 4 weeks.
[Part 1.2] Placebo of IDG-16177Drug
[Part 1.2] Administration once daily for 14 days.
[Part 2] Placebo of IDG-16177Drug
[Part 2] Administration once daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| [Part 1.1] IDG-16177 | Experimental | 6 subjects in each cohort (Cohort 1-5). The SAD study (Part 1.1) will consist of 5 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of IDG-16177 or placebo (6 active treatments and 2 placebo/3:1 ratio). Subjects in Cohort 4 will participate in a food-effect study. Receives: Drug: [Part 1.1] IDG-16177 |
| [Part 1.1] Placebo of IDG-16177 | Placebo comparator | 2 subjects in each cohort (Cohort 1-5). The SAD study (Part 1.1) will consist of 5 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of IDG-16177 or placebo (6 active treatments and 2 placebo/3:1 ratio). Subjects in Cohort 4 will participate in a food-effect study. Receives: Drug: [Part 1.1] Placebo of IDG-16177 |
| [Part 1.2] IDG-16177 | Experimental | 8 subjects in each cohort (Cohort 6-8). The MAD study (Part 1.2) will consist of 3 cohorts of 10 healthy subjects (8 active treatments and 2 placebo/4:1 ratio), each receiving an oral dose of IDG-16177 or placebo. Receives: Drug: [Part1.2] IDG-16177 |
| [Part 1.2] Placebo | Placebo comparator | 2 subjects in each cohort (Cohort 6-8). The MAD study (Part 1.2) will consist of 3 cohorts of 10 healthy subjects (8 active treatments and 2 placebo/4:1 ratio), each receiving an oral dose of IDG-16177 or placebo (QD). Receives: Drug: [Part 1.2] Placebo of IDG-16177 |
| [Part 2] IDG-16177 | Experimental | This part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator. Receives: Drug: [Part 2] IDG-16177 |
| [Part 2] Placebo | Placebo comparator | This part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator. Receives: Drug: [Part 2] Placebo of IDG-16177 |
| [Part 2] Sitagliptin | Active comparator | This part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator (1:1:1 ratio). Receives: Drug: [Part 2] Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs/serious AEs (SAEs)
Incidence and severity of adverse event
Measured: Throughout study duration, up to 9 weeks
Percentage of subjects with clinically significant change from baseline in vital signs
Measured: Throughout study duration, up to 9 weeks
Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)
Measured: Throughout study duration, up to 9 weeks
Percentage of subejcts with clinically significant change from baseline in safety laboratory test results
Measured: Throughout study duration, up to 9 weeks
Secondary outcomes (10)
Maximum concentration of IDG-16177(Cmax)
Measured: Throughout study duration, up to 9 weeks
Time of maximum plasma IDG-16177 concentration (Tmax)
Measured: Throughout study duration, up to 9 weeks
Area under the concentration-time curve (AUC)
Measured: Throughout study duration, up to 9 weeks
Terminal elimination rate constant (λz)
Measured: Throughout study duration, up to 9 weeks
Terminal elimination half-life calculated as: ln2/λz (T½)
Measured: Throughout study duration, up to 9 weeks
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Measured: Throughout study duration, up to 9 weeks
Cumulative urinary excretion from time 0 to time t (Ae0-t)
Measured: Throughout study duration, up to 9 weeks
Renal clearance of the drug from plasma (CLR)
Measured: Throughout study duration, up to 9 weeks
Accumulation ratio (Rac)
Measured: Throughout study duration, up to 9 weeks
Apparent volume of distribution following oral administration (Vd/F)
Measured: Throughout study duration, up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start7 Jul 2021
- Primary completion9 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982705
- Sponsor's protocol ID
- IDG16177-T2DM-101
- Other IDs
- 2021-001082-21
- Status last verified
- Aug 2022
- First submitted
- 5 Jul 2021
- Last updated
- 11 Aug 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 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo- and Active-controlled, Randomised, Double-blind, Dose-escalation Phase I Study of IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics With the Exploration on Its Pharmacodynamics and Efficacy
- ClinicalTrials.gov ID
- NCT04982705
- Acronym / sponsor ID
- IDG16177-T2DM-101
- Conditions
- Type 2 Diabetes
- Keywords
- T2DM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 9 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 29 Jul 2021 (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 Phase I, first-in-human, randomised, double-blinded, placebo-and active-controlled study to assess the safety, tolerability, PK, PD, efficacy, and food-effect of IDG-16177 in healthy male subjects and patients with T2DM at different dose levels.
Detailed description
This study consists of 2 parts: Part 1 is a dose-escalation study in healthy male subjects in single ascending dose (SAD) (Part 1.1) including food-effect and multiple ascending dose (MAD) (Part 1.2) cohorts to determine the highest allowable dose (HAD) for patients with T2DM; and Part 2 is a placebo- and active-controlled efficacy exploration in patients with T2DM, insufficiently controlled with metformin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| [Part 1.1] IDG-16177 | Experimental | Drug: [Part 1.1] IDG-161776 subjects in each cohort (Cohort 1-5). The SAD study (Part 1.1) will consist of 5 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of IDG-16177 or placebo (6 active treatments and 2 placebo/3:1 ratio). Subjects in Cohort 4 will participate in a food-effect study. |
| [Part 1.1] Placebo of IDG-16177 | Placebo comparator | Drug: [Part 1.1] Placebo of IDG-161772 subjects in each cohort (Cohort 1-5). The SAD study (Part 1.1) will consist of 5 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of IDG-16177 or placebo (6 active treatments and 2 placebo/3:1 ratio). Subjects in Cohort 4 will participate in a food-effect study. |
| [Part 1.2] IDG-16177 | Experimental | Drug: [Part1.2] IDG-161778 subjects in each cohort (Cohort 6-8). The MAD study (Part 1.2) will consist of 3 cohorts of 10 healthy subjects (8 active treatments and 2 placebo/4:1 ratio), each receiving an oral dose of IDG-16177 or placebo. |
| [Part 1.2] Placebo | Placebo comparator | Drug: [Part 1.2] Placebo of IDG-161772 subjects in each cohort (Cohort 6-8). The MAD study (Part 1.2) will consist of 3 cohorts of 10 healthy subjects (8 active treatments and 2 placebo/4:1 ratio), each receiving an oral dose of IDG-16177 or placebo (QD). |
| [Part 2] IDG-16177 | Experimental | Drug: [Part 2] IDG-16177This part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator. |
| [Part 2] Placebo | Placebo comparator | Drug: [Part 2] Placebo of IDG-16177This part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator. |
| [Part 2] Sitagliptin | Active comparator | Drug: [Part 2] SitagliptinThis part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator (1:1:1 ratio). |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- [Part 1 and Part 2] Subjects/Patients who meet the following criteria will be considered eligible to participate in Part 1 or Part 2 of the clinical study:
- 1. Subject voluntarily/Patient agrees to participate in this study and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures. 2. Subject/Patient is able to understand the nature of the clinical study. 3. Subject/Patient is able to read and speak German. 4. Subject/Patient is able to communicate satisfactorily with the Investigator and study team and follow the entire requirements of the clinical study. [Part 1] Subjects who meet the following criteria will be considered eligible to participate in Part 1 of the clinical study:
- Healthy male subjects aged 19 to 55 years at the time of Screening.
- Subject weighs at least 60 kg and has a body mass index (BMI)between 18.5 and 29.9 kg/m2, inclusive, at Screening.
- Subject who is healthy and judged to be eligible to participate in the study at the Screening test (based on medical history, physical examination, vital sign, 12 lead ECG, and laboratory test including serology test).
Key exclusion criteria (34 listed)
- [Part 1 and Part 2] Subjects/Patients who meet one or more of the following criteria will not be considered eligible to participate in Part 1 or Part 2 of the clinical study:
- Subject/Patient is an employee or a family member of the Sponsor or the involved CRO.
- Vulnerable subject (i.e., persons under any administrative or legal supervision or persons kept in detention).
- Subject/Patient who has a positive reverse transcription polymerase chain reaction (RT PCR) test for SARS-CoV-2 prior to randomisation.
- Subject/Patient who has clinical signs and symptoms consistent with SARS-CoV-2 infection; eg, fever, dry cough, dyspnea, sore throat, fatigue, or positive SARS-CoV-2 test result within 2 weeks prior to Screening.
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 |
|---|---|---|
| [Part 1.1] IDG-16177[Part 1.1] Subjects will receive a single oral dose of IMP. Dose strenght for each cohort (Cohort 1-5) is planned as 0.5, 1, 2, 5, 10mg, respectively. | Drug | [Part 1.1] IDG-16177 |
| [Part 1.1] Placebo of IDG-16177[Part 1.1] subjects will receive a single oral dose of IMP. | Drug | [Part 1.1] Placebo of IDG-16177 |
| [Part 2] SitagliptinAdministration of Sitagliptin 100mg once daily for 4 weeks. | Drug | [Part 2] Sitagliptin |
| [Part1.2] IDG-16177[Part 1.2] Administration once daily for 14 days; Dose strenght for each cohort (Cohort 6-8) is planned as ≤ 2, ≤ 4, ≤ 8mg, respectively. | Drug | [Part 1.2] IDG-16177 |
| [Part 2] IDG-16177[Part 2] Administration once daily for 4 weeks. | Drug | [Part 2] IDG-16177 |
| [Part 1.2] Placebo of IDG-16177[Part 1.2] Administration once daily for 14 days. | Drug | [Part 1.2] Placebo |
| [Part 2] Placebo of IDG-16177[Part 2] Administration once daily for 4 weeks. | Drug | [Part 2] Placebo |
Primary outcome
AEs/serious AEs (SAEs)
Time frame: Throughout study duration, up to 9 weeks
Incidence and severity of adverse event
Percentage of subjects with clinically significant change from baseline in vital signs
Time frame: Throughout study duration, up to 9 weeks
Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)
Time frame: Throughout study duration, up to 9 weeks
Percentage of subejcts with clinically significant change from baseline in safety laboratory test results
Time frame: Throughout study duration, up to 9 weeks
10 secondary outcomes
Maximum concentration of IDG-16177(Cmax)
Time frame: Throughout study duration, up to 9 weeks
Time of maximum plasma IDG-16177 concentration (Tmax)
Time frame: Throughout study duration, up to 9 weeks
Area under the concentration-time curve (AUC)
Time frame: Throughout study duration, up to 9 weeks
Terminal elimination rate constant (λz)
Time frame: Throughout study duration, up to 9 weeks
Terminal elimination half-life calculated as: ln2/λz (T½)
Time frame: Throughout study duration, up to 9 weeks
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Time frame: Throughout study duration, up to 9 weeks
Cumulative urinary excretion from time 0 to time t (Ae0-t)
Time frame: Throughout study duration, up to 9 weeks
Renal clearance of the drug from plasma (CLR)
Time frame: Throughout study duration, up to 9 weeks
Accumulation ratio (Rac)
Time frame: Throughout study duration, up to 9 weeks
Apparent volume of distribution following oral administration (Vd/F)
Time frame: Throughout study duration, up to 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [Part 1.1] IDG-16177, [Part 2] Sitagliptin and [Part1.2] IDG-16177 in people with Type 2 Diabetes, run by IlDong Pharmaceutical Co Ltd at 1 site in Germany.
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 14 inclusion and 34 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 11 Aug 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ILDONG Pharmaceutical Co., Ltd. (+82(2)526-3441, jsy@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs/serious AEs (SAEs) (time frame: Throughout study duration, up to 9 weeks). The study lists 4 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 Aug 2022.