None listed
Conditions
Interventions
Intervention1: Oral Insulin: 16mg(2capsules)insulin/day at bed time, treatment for 6 weeks, total enrollment period 8 weeks
Control Intervention1: Placebo: Placebo at bed time, treatment for 6 weeks,
Sponsors
Oramed Inc
ETI Karle clinical
PharmaLeaf - Regulatory Agency
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female subjects aged 20 to 60 years inclusive. 2. FBG ≥130 to ≤ 200 mg/dl 3. Confirmed diagnosis of Type 2 diabetes as defined by WHO criteria (fasting venous plasma glucose concentration ≥ 7.0 mmol/L or 2-h post-glucose load venous plasma glucose ≥ 11.1 mmol/L) treated with diet alone or diet and Metformin (up to 2.5 g/day) (any type and regimen) for at least three months with HbA1c 7.5% ≥ 10.5% at screening Visit. 4. BMI ≤ 33 5. Generally in good health, as evidenced by lack of significant findings in medical history, physical examination, clinical laboratory tests, vital signs, and ECG. 6. Able to understand and sign the written informed consent and be willing to follow the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Refusal or inability to give informed consent to participate in the study 2. Participation in or administration of any clinical trials or investigational drugs within 30 days prior to the screening Visit. 3. Presence of any clinically significant endocrine disease according to the Investigator (euthyroid subjects on replacement therapy will be included if the dosage of thyroxine is stable for at least three months prior to screening Visit) 4. Presence of Type I diabetes (C-peptide < 1.0 ng/mL) 5. Presence of any clinically significant condition that might interfere with the evaluation of study medication 6. Presence or history of cancer within the past five years with the exception of adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer 7. Laboratory abnormalities including: - C-peptide < 1.0 ng/mL - Positive urine pregnancy test in females of childbearing potential at screening Visit - Abnormal serum thyrotropin (TSH) levels at screening Visit - Positive test for hepatitis B surface antigen and/or hepatitis C antibody at screening Visit - Any relevant abnormality interfering with the efficacy or the safety assessments during the study drug administration Some medications: - Administration of antidiabetic drugs other than metformin within three months prior to screening Visit - Administration of thyroid preparations or thyroxine (except in subjects on stable replacement therapy) within three months prior to screening Visit - Administration of systemic long-acting corticosteroids within two months or prolonged use (more than one week) of other systemic corticosteroids or inhaled corticosteroids (if daily dosage is > 1,000 &#956;g equivalent beclomethasone) within 30 days prior to screening Visit 8. Pregnancy or Breast-feeding 9. History of drug or alcohol abuse or addiction within the past 5 years 10. Current tobacco use of more than 10 cigarettes per day or equivalent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability of oral insulinTimepoint: Treatment period of 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The secondary objective of this study is to compare the changes in levels of fasting glucose, c-peptide and insulin in two groups of subjects with Type 2 Diabetes Mellitus currently on diet alone or diet with a monotherapy consisting of Metformin of up to 2.5 g/day; one group of subjects will receive an oral insulin capsule once daily and another group of subjects will receive a placebo once daily. 2&#61472; To compare the change in fasting plasma glucose (FPG) values, as well as fructosamine and HbA1c in subjects who have been treated with oral insulin or placebo. 3.To evaluate the plasma levels of insulin as well as the C-Peptide levels in subjects that has been treated with oral insulin or placebo.Timepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr.Rekha
Project Manager-Clinical Operations, ETI Karle Clinical Pvt Ltd.
Outcome results
None listed