Health Condition 1: null- Type 2 Diabetes mellitus
Conditions
Interventions
Intervention1: IN-105: 10, 15, 20, 30 mg
Method of administration - oral
Frequency of administration -oral
Control Intervention1: Placebo:
Sponsors
Biocon Limited
Secondary Sponsor None
Eligibility
Inclusion criteria
Inclusion criteria: Males Females who are not at risk of getting pregnant (postmenopausal, females who have undergone tubectomy) Age - 30 to 65 years. Body Mass Index ≤29.9 Kg/m2. ? Willingness to provide written informed consent to participate in the study. ? Fasting blood glucose (FBS) 130 mg/dL or above ? Glycosylated hemoglobin (HbA1c) concentration 7.5-9.5% ? Currently treated with Metformin extended-release tablet with dose ranging between 500 ? 1500 mg per day, including previous 12 weeks. ? Essential hypertension is permitted if well controlled on stable doses (at least 3 months prior to the screening visit) of antihypertensives. ? Willingness to stay in the clinical facility and/or fulfill the study requirement for the entire duration of the study.
Exclusion criteria
Exclusion criteria: Females of childbearing potential. Pregnant and lactating women. History or evidence of hypersensitivity to the test drug or any of its constituents or allergy to drugs chemically similar to the drug under investigation. Current or past treatment with Insulin to control diabetes. History or presence of significant o Alcohol dependence, alcohol abuse or drug abuse durin one year. o Smokers who smoke more than 5 cigarettes/day o Asthma, urticaria or other allergic type reactions after aspirin. o Ulceration or history of gastric and / or duodenal ulcer o Of Jaundice in the past 6 months. o Any bleeding disorder. Two or more serious hypoglycemic episodes within six months prior to study Hospitalization or emergency room visit [for poor diabetes control] within the six months prior to study. Taking steroids, and /or niacin. Taking other non-excluded medications (metformin and antihypertensive agents), without stable dose of medication for at least 12 weeks. Major illness or debility in the last 3 months. History of clinically significant complications associated with diabetes mellitus, including proliferative retinopathy or legal blindness, nephropathy [serum creatinine level greater than 2.0 mg/dl], signs of autonomic neuropathy, such as gastroparesis or orthostatic hypotension, and peripheral vascular insufficiency based on the investigator?s assessment/discretion. Any clinically significant diseases or abnormal findings during screening, medical history, physical examination, laboratory evaluation, 12-lead ECG, Chest X-ray (PA view) at screening or baseline, which should in the opinion of the investigator exclude the subject from entering the study Tests Positive for laboratory tests for hepatitis B, hepatitis C and HIV. History of psychiatric disorder [including drug or alcohol addiction] that required care by a physician or psychologist within the preceding 12 months. History of or current medication other than Metformin for the control of diabetes. Donation of 450 mL or more blood in the previous 3 months before the start of this study Subjects who have participated in another clinical study in the past 12 weeks of commencement of the study. History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Examine the effect of single ascending doses of IN-105 on the plasma glucose concentrations (pharmacodynamics), under fed conditions, in type 2 diabetes subjects who are currently on Metformin therapy.Timepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| Examine the effect of single ascending doses of IN-105 on the pharmacokinetics and safety and tolerability, under fed conditions, in type 2 diabetes subjects who are currently on Metformin therapy.Timepoint: | — |
Countries
India
Contacts
Public ContactFamida Khan
Biocon Research limited
Outcome results
None listed