CTRI/2011/04/001661
Recruiting
Phase 1
A placebo-controlled, randomized, rising multiple dose study of ADV-1002401 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in adult male Type-II diabetic subjects - NI
Advinus Therapeutics Ltd0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Sponsor
- Advinus Therapeutics Ltd
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Non\-smoking, male diabetics aged between 18 and 60 years (including both) with BMI between 20 to 36 kg/m2 (including both).
- •2\.T2DM diagnosed subjects (with minimum of 6 months) who are not adequately controlled with metformin will only be enrolled in the study.
- •3\.Fasting blood glucose of 125 to 220 mg/dL.
- •4\.Successful completion of treatment\-free washout period of ¡Ý 2 weeks from current metformin medications.
- •5\.HbA1c greater than or equal to 7%, and less than or equal to 10\.5%.
- •6\.C\-peptide 0\.81 ng/mL at screening.
- •7\.Otherwise normal health (exceptions stated in Section 12\.0\) as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range.
- •8\.Clinically acceptable 12\-lead electrocardiogram (ECG).
- •9\.Clinically acceptable chest X\-Ray (P/A view).
- •10\.Negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
Exclusion Criteria
- •The subjects will be excluded from the study, if they meet any of the following criteria:
- •1\.Hypersensitivity to anti\-diabetic or related drugs.
- •2\.History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine disorders other than T2DM, immunological, dermatological, neurological or psychiatric disease or disorder.
- •3\.Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
- •4\.Use of any prescribed medication during last two weeks or OTC medicinal products (including herbal preparations) during the last one week prior to initiation of study.
- •5\.Use of Pravastatin within 2 weeks prior to receiving ADV\-1002401\.
- •6\.History or presence of significant alcoholism or drug abuse in the past one year (Appendix VIII from DSM\-IV).
- •7\.History or presence of smoking or use of other tobacco, pan, gutkha products since last 06 months.
- •8\.History or presence of significant asthma, urticaria or other allergic reactions.
- •9\.History or presence of significant gastric and/or duodenal ulceration.
Outcomes
Primary Outcomes
Not specified
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