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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1186-6753 | Other Identifier | World Health Organization (WHO) |
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This study looks at the way a new medicine tablet called semaglutide moves in and throughout the body over time. It will also look at if the medicine is safe and the body can accept it. The new medicine is planned to treat diabetes. The aim of the study is to see how semaglutide tablets work in healthy people who are Chinese. Participants will either get oral semaglutide tablets or placebo (dummy) tablets - which treatment is decided by chance. The tablet form of semaglutide is a new medicine that cannot be prescribed. Doctors can prescribe semaglutide as an injection only. It is for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 12 weeks (84 days). Participants will get 1 tablet a day to take with up to half a glass of water (maximum 120 mL). Participants must take the tablet first thing in the morning on an empty stomach (water is allowed until 2 hours before taking the tablet). After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After 30 minutes, they can have their first meal of the day and take any other medicines they may need, such as birth control tablets, routine vitamins and use of paracetamol at times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral semaglutide | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral semaglutide | Drug | Semaglutide tablets once daily as follows: 3 mg for the first treatment period (day 1-28), followed by 7 mg in the second treatment period (day 29-56), followed by 14 mg in the third treatment period (day 57-84) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,sema,SS, area under the semaglutide concentration-time curve during a dosing interval (0-24 hours) at steady state | h*nmol/L | After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,sema,SS, maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state | nmol/L | After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital-phase I | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38808476 | Result | Xie P, Abildlund MT, Baekdal TA, He X, Lyauk YK, Patted URH, Ning Z, Shi A. A phase 1, randomized, double-blind, placebo-controlled trial investigating the pharmacokinetics, pharmacodynamics, safety and tolerability of oral semaglutide in healthy Chinese subjects. Diabetes Obes Metab. 2024 Aug;26(8):3068-3077. doi: 10.1111/dom.15624. Epub 2024 May 29. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures
| Placebo | Drug | Placebo tablets once daily throughout the treatment period (day 1 to 84) |
|
| tmax,sema,SS, time to maximum observed semaglutide plasma concentration during a dosing interval (0-24 hours) at steady state |
h |
| After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84 |
| CL/Fsema,SS, total apparent clearance of semaglutide at steady state | L/h | After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84 |
| Ctrough,sema,SS, trough semaglutide plasma concentration at steady state | nmol/L | After the last 3 daily doses of oral semaglutide administration at 3, 7 and 14 mg dose levels on day 27-29, 55-57 and 83-85 |
| t½,sema,SS, terminal half-life of semaglutide at steady state | h | After the last dose of oral semaglutide 14 mg on day 84 |
| Vss/Fsema, apparent volume of distribution of semaglutide at steady state | L | After the last dose of oral semaglutide 14 mg on day 84 |
| MRTsema,SS, mean residence time of semaglutide at steady state | h | After the last dose of oral semaglutide 14 mg on day 84 |
| Rtheor,sema,SS, theoretical accumulation index, which is defined as [1/(1-Exp (-λZ,sema,SS*24h))], where λZ,sema,SS=log(2)/t½,sema,SS | Index value | After the last dose of oral semaglutide 14 mg on day 84 |
| Change in body weight from baseline | kg | Day 1, day 85 |
| Change in fasting plasma glucose from baseline | mmol/l | Day 1, day 85 |
| Number of treatment-emergent adverse events | Count | From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121) |
| Number of treatment-emergent hypoglycaemic episodes | Count | From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121) |
| D004700 | Endocrine System Diseases |