Testing the safety and effects of a new drug (G3215) in adult subjects

Phase 1

Completed

• Conditions: Diabetes Mellitus Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN67889041
• Lead Sponsor: Imperial College London

Brief Summary

2024 Results article in https://doi.org/10.1111/dom.15448 (added 18/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-03
• Study Completion: 2021-10-22
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Current inclusion criteria as of 07/09/2021:
1. Adult males aged 18 to 65 years inclusive with BMI between 25.0 and 45.0 kg/m² inclusive
2. Subjects may have normal glucose tolerance, Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria
3. The following criteria apply to subjects with Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria
3.1. They should be stably treated either with:
3.1.1. Diet and lifestyle changes only
3.1.2. Monotherapy with a sulphonylurea, metformin, or SGLT-2 inhibitor; or
3.1.3. Dual therapy with sulphonylurea/metformin, or sulphonylurea/SGLT-2 inhibitor
3.2. Patients treated with triple anti-diabetic treatments are excluded
3.3. The HbA1c at screening should be 6.0–8.5% (42–69 mmol/mol) and <±1.0% (±11 mmol/mol) from a previous HbA1c reading within the last 6 months, where available. Where an HbA1c reading within the last 6 months is not available, the subject should have HbA1c re-measured after at least 4 weeks to assure stability of glycaemia before inclusion in the study. This remeasurement may take place any time up to and including check in on Day -1
3.4. To allow assessment of eligibility, subjects without known diabetes or prediabetes, or in whom the glycaemic status is in doubt, may undergo a pre-screening visit no more than 10 weeks before Day 1 for assessment of fasting glucose, HbA1c and glucose 2 hours after a 75 g oral glucose tolerance test
4. Subjects who are otherwise healthy enough to participate, as determined by pre-study medical history, physical examination and 12-lead ECG
5. Subjects whose clinical laboratory test results are either within the normal range or if outside this range the abnormalities are judged to be not clinically relevant and are acceptable to the Investigator
6. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody test and human immunodeficiency virus (HIV) I and II antibody tests at screening
7. Subjects who are negative for drugs of abuse and nicotine tests at screening and admissions
8. Subjects who do not take nicotine (including consumption of tobacco by any means or use of nicotine delivery systems) for at least 3 months preceding screening
9. Subjects who agree to use acceptable methods of contraception (see 7.2.3.1 and 7.2.3.2) for at least 3 months after study drug administration
10. Subjects who agree not to donate sperm for at least 3 months after study drug administration
11. Subjects who are able and willing to give written informed consent

Previous inclusion criteria:
1. Adult males aged 18 to 65 years inclusive with BMI between 25.0 and 38.0 kg/m² inclusive
2. Subjects may have normal glucose tolerance, Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria
3. The following criteria apply to subjects with Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria
4. They should be stably treated either with:

Exclusion Criteria

1. Subjects who do not conform to the above inclusion criteria
2. Subjects who have a relevant history or presence of gastrointestinal (especially associated with vomiting), respiratory, renal, hepatic, haematological, lymphatic, neurological (especially if associated with balance disorders or vomiting e.g. migraine or labyrinthitis), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders that in the Investigator’s opinion will compromise safety, practicability or scientific value of the study
3. Subjects who have a relevant surgical history that in the Investigator’s opinion will compromise safety, practicability or scientific value of the study
4. Subjects who have used prescription drugs within 4 weeks of first dosing, with the following exceptions:
a. Anti-diabetic drugs as specified in the inclusion criteria.
b. Hypolipidaemic and/or antihypertensive treatments, provided that the doses have not been altered within the 4 weeks prior to entering the study.
c. Other medications may be allowed if the Investigator judges that they will not affect the outcome of the study or the safety of the subject.
5. Subjects who have used over the counter medication excluding routine vitamins and paracetamol but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as not clinically relevant by the Investigator and Sponsor
6. Subjects who have a history of relevant and severe atopy e.g. asthma, angioedema requiring emergency treatment, severe hayfever requiring regular treatment (i.e. taking antihistamines and/or glucorticoids more regularly than 3 times a week), severe eczema requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week)
7. Subjects who have a history of relevant drug hypersensitivity
8. Subjects who have a history of alcohol abuse or alcohol dependence according to DSM-IV criteria within the last two years
9. Subjects who have a history of drug or substance abuse according to DSM-IV criteria within the last 2 years
10. Subjects who have a history of clinically significant migraine as judged by the Investigator. Subjects can be included if they have not had a migraine for the last 3 years
11. Subjects with a history of pancreatitis or pancreatic cancer
12. Subjects who consume more than 21 units of alcohol a week (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)
13. Subjects who have a significant infection or known inflammatory process on screening
14. Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn)
15. Subjects who have an acute infection such as influenza at the time of screening or admission
16. Subjects who have donated blood within 3 months prior to screening
17. Subjects who have donated plasma within the 7 days prior to screening
18. Subjects who have donated platelets within the 6 weeks prior to screening
19. Subjects who have used any investigational drug in any

Study & Design

• Study Type: Interventional
• Study Design: Not specified