A Clinical trial of a drug (ADV-1002401) to evaluate safety, tolerability, in adult male Type-II diabetic subjects
- Conditions
- Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2011/04/001661
- Lead Sponsor
- Advinus Therapeutics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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).
11.Negative alcohol breath test.
12.Willingness to adhere to the protocol requirements and to provide written informed consent.
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.
10.History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
11.History or presence of cancer.
12.Difficulty with donating blood.
13.Major illness during 3 months before screening.
14.Participation in a drug research study within past 3 months.
15.Donation of blood in the past 3 months before screening.
16.Inability to consume 250 mL of fluid (150 mL buffered vehicle pH 7.4 followed by 100 mL of water) without emesis and discomfort.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of rising multiple oral doses of ADV-1002401 in male subjects with Type-II diabetes mellitus (T2DM) administered once daily for 14 daysTimepoint: 14 days
- Secondary Outcome Measures
Name Time Method 1.To assess the pharmacokinetics of ADV-1002401 following a single dose, and following multiple daily oral doses for 14 consecutive days of ADV-1002401 in male T2DM subjects under fasting conditionsTimepoint: 14 days;2.To assess the pharmacodynamic effect of ADV-1002401 following a single dose, and following multiple daily oral doses for 14 consecutive days of ADV-1002401 in male T2DM subjects, on the following parameters: <br/ ><br>a)Fasting plasma glucose <br/ ><br>b)Fasting serum fructosamine <br/ ><br>c)Plasma glucose, serum insulin, serum C-peptide, and serum glucagon during oral glucose tolerance test (OGTT) and during mixed meal tolerance test (MMTT) <br/ ><br>Timepoint: 14 days