Type 2 Diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Product Name: PSN821AA
Product Code: PSN821AA
Pharmaceutical Form: Oral suspension
Current Sponsor code: PSN821AA
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration num
Sponsors
Prosidion Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent obtained before any study-related activities 2. Male and female patients with a diagnosis of type 2 diabetes mellitus according to ADA criteria at least 4 months prior to screening 3. Medical history without major pathology (with the exception of type 2 diabetes) 4. On a stable regimen of metformin monotherapy (minimum of 850 mg/day) prior to screening (medication type and dose unchanged for the last 3 months) 5. Aged between 18 and 65 years of age, both inclusive 6. Body mass index (BMI) between 25 and 40kg/m2, both inclusive 7. HbA1c between 6.8 and 9.5 %, both inclusive 8. Fasting plasma glucose (FPG) between 126 and 270 mg/dL (7-15 mmol/L), both inclusive 9. A female patient is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis 2. Current or previous treatment with insulin therapy 3. Treatment with any hypoglycaemic medication other than metformin within the three months prior to screening 4. Patients with any severe medical or surgical history of conditions likely to confound study assessments or study endpoints20. Participation in another clinical trial within the 3 months preceding screening or 5-halflives 5. Serious respiratory, serious and/or unstable coronary heart disease 6. History of arrhythmia 7. Marked diabetic complications 8. Clinically significant vital signs or 12-lead ECG findings including pre-treatment QTcF > 450msec 9. Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests 10. Moderate or severe renal dysfunction 11. Clinical or laboratory evidence of hepatic dysfunction or disease 12. Uncontrolled high blood pressure (DBP > 95 mmHg and/or SBP > 160 mmHg) 13. History of any psychiatric condition that might impair the patient’s ability to understand or to comply with the requirements of the study or to provide informed consent 14. History of relevant drug and/or food allergies or a history of severe anaphylactic reaction 15. Smoking more than 5 cigarettes/cigars/pipes daily 16. Currently active or history of alcohol abuse 17. Positive screen for drugs of abuse or alcohol test at screening 18. Use of concomitant medication which would confound study conduct 19. Use of drugs that have a known risk of causing Torsades de Pointes are prohibited within 14 days prior to randomisation. 20. Participation in another clinical trial within the 3 months preceding screening or 5-halflives of drug studied, whichever is longer, prior to study medication administration 21. Participation in more than three other clinical trials in the ten months preceding screening 22. Malignancy within 5 years of study start, except for successfully treated local basal cell carcinomas 23. Patients known to be positive for Hepatitis B surface antigen or Hepatitis C antibodies (or diagnosed with active hepatitis according to local practice) 24. Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies or HIV-1 antigen according to locally used diagnostic testing 25. Patients in whom metformin is contraindicated according to the local SPC 26. Use of concomitant medication which would be likely to interact with metformin (according to the Patient information leaflet) 27. Patient who has donated or lost more than 500 mL blood within 3 months prior to screening 28. Significant illness within five days prior to the first administration of study medication 29. History of hypersensitivity to the study medication or any of the excipients or to medicinal products with similar chemical structures 30. Veins unsuitable for repeat venipuncture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the pharmacodynamic response of single oral doses of PSN821 following a MMTT (based on the area under the glucose concentration-time curve from 1-6 hours post-dose, i.e. from 0-5 hours after a MMTT) • To establish the dose response relationship for the glucose lowering effect of PSN821 using reactive glucose area under the curve (AUC);Secondary Objective: • To compare other pharmacodynamic properties (based on glucose, insulin and C-peptide measurements) of single oral doses of PSN821 before and following a MMTT • To compare the pharmacokinetic (PK) exposure and properties of each single oral dose for 12h post-dosing • To assess the PK/PD relationship (based on AUC PSN821 and AUC glucose) • To assess the short-term safety after single oral dosing;Primary end point(s): The primary (PD) endpoint of the study is: - AUCPG(5h) area under the plasma glucose concentration-time profile from 1-6 hours postdose (i.e. from 0-5 hours after a MMTT) | — |
Countries
Germany
Outcome results
None listed