A Phase II, 12-Week Randomised, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate Safety, Tolerability, Pharmacokinetics and Effect On Glycemic Control of P1736-05 in Subjects with Type 2 Diabetes Mellitus - P1736-05 POC study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

1. Age : 18- 65 yrs, inclusive 2. BMI : 25 - 40 kg/m2, inclusive 3. HbA1c: at screening between 7 and 10% for subjects on diet and exercise 4. FPG : at randomization =12.5 mmol/l 5. Fasting C-peptide: at screening =0.16nmol/L (>0.5ng/ml) 6. For females: negative pregnancy test at screening and each admission, or of no childbearing potential (females) (a prerequisite for female subjects of childbearing potential is adequate contraception during the study and until 3 months after the follow-up visit) Postmenopausal females: postmenopausal usually based on history of amenorrhoea duration (no menstrual period for 24 consecutive months) 7. Has an established clinical diagnosis of stable type 2 diabetes mellitus for at least 3 months prior to the screening period; (Type 2 Diabetes Mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization (WHO) Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2006] 8. Drug naive (Defined as subjects not received any pharmacological treatment for at least 12 weeks before screening and no anti diabetic agents for > 3 consecutive months any time in the past). 9. Is on a stable weight, with no more than a 4% gain or loss in the 3 months prior to screening (by history).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. MODY (Mature Onset Diabetes of the Young), insulin dependent type 2 diabetes mellitus, or other unusual or rare forms of diabetes mellitus 2. Has had >4 episodes of severe hypoglycemia that required the assistance of another person within the past 6 months (brittle diabetes) 3. Type 2 Diabetes of more than 15 years duration prior to screening. 4. Has a history of acute metabolic diabetic complications such as ketoacidosis or hyperosmolar nonketotic coma 5. Has used insulin previously within past 3 months prior to screening 6. Has used GLP-1 analog (for example, exenatide) within 6 months prior to screening 7. Has used Thiazolidinediones or DPP4 inhibitors within 6 months prior to screening. 8. Has received any investigational drug within 60 days prior to study entry 9. Has a history of hypersensitivity or allergies to similar class of drug as the study drug, unless approved by the Investigator 10. Has a clinically significant history of substance or alcohol abuse within the past year or a current diagnosis of substance or alcohol abuse 11. Has a positive serology for an infectious disease (including HIV, Hepatitis B or C) at Screening 12. Has donated blood (=500mL) within the three months preceding the screening period or suffered significant blood loss equal to a donor portion (approx 500mL). 13. Has history of clinically significant disease other than type 2 diabetes (endocrine, hepatic, renal, Metabolic, neurological, psychiatric, cardiovascular, pulmonary, gastrointestinal, Hematological or gynecological disease (including subjects with diabetic end organ Disease (renal, cardiac, and retinal) o Subjects with significant renal insufficiency, only one functioning kidney, history of renal transplantation, or currently receiving renal dialysis o Subjects with creatinine clearance <60 mL/min as determined by Cockcroft and Gault formula o Subjects with Serum creatinine =1.5 mg/dL or =132.6 µmol/L o Subjects with a clinically significant abnormal WBC count, thrombocytopenia, or anemia at screening o Subjects with history or presence of proliferate retinopathy, macular degeneration or edema, retinal detachment, and/or severe vision impairment (i.e. subject requires assistance in daily tasks) o Subjects with hepatic disease or clinically relevant evidence of it (i.e. values at screening and at pre-randomization of more than 2 x ULN for aspartate aminotransferase [AST], alanine aminotransferase [ALT] or values of more than 1.5 x ULN for bilirubin or alkaline phosphates. Subjects with high bilirubin associated with Gilbert’s syndrome will not be excluded o Subjects who have a history of malignancy o Subjects with cardiovascular disease within the previous 6 months prior to screening (including, but not limited to, myocardial infarction, stroke, peripheral vascular disease, ischemic changes resting ECG) o Subjects with severe and uncontrolled hypertension (blood presure above 160/100) o Subjects with a history of unhealed diabetic ulcer o Subjects with hypo or hyperthyroidism 14. Subjects who have been hospitalized for any psychiatric illness in the past year, or are diagnosed with major depression. 15. Subjects with any other clinically significant laboratory abnormality at screening 16. Has a clinical condition or receiving therapy that, in the opinion of the Investigator, would make the subjects unsuitable for study. 17. Subjects who have received in the 3 months prior to screening, any systemic glucocorticoid treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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