Health Condition 1: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: Insulin Tregopil (IN-105): Strength: 30 mg or 45 mg in part I and chosen dose in Part II. Administered TID 10 minutes prior to the each of 3 major meals of the day. The starting dose w
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria: 1. Patients with an established diagnosis of T2DM and a duration of diabetes mellitus of at least 6 months at Screening based on criteria given below as per American Diabetes Association (ADA) 2017 guidelines: i. HbA1c >= 6.5% OR ii. FPG >= 126 mg/dL. (Fasting is defined as no caloric intake for at least 8 hours.) OR iii. 2-hour prandial glucose (PG) level of >= 200 mg/dL during an oral glucose tolerance test (OGTT). The test should be performed as described by the World Health Organisation (WHO), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR iv. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose >= 200 mg/dL. (If there is suspicion, the investigator can do a fasting plasma C-peptide [Levels 2. Stable dose of metformin (at least 1500 mg daily [daily dose of at least 1000 mg is permitted if intolerant to 1500 mg dose]) for a period of at least 3 months prior to Screening 3. Eligible for initiation of or already receiving insulin glargine 4. Hemoglobin >= 10.0 g/dL 5. HbA1c of 7.5% to 10.0 % 6. Body mass index of 18.5 to 35.0 kg/m2
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: 1. Patients with T1DM 2. Treatment with glucagon-like peptide 1 agonists within 12 weeks prior to Screening 3. Ongoing treatment with OADs (eg, Thiazolidinediones) contraindicated or unapproved for combination treatment with insulin 4. Presence of gastrointestinal (GI) disorders or conditions known to significantly alter the absorption of orally administered drugs or significantly alter upper GI or pancreatic function 5. History of >=2 episodes of severe hypoglycemia (as per ADA 2017) within the 6 months before Screening 6. History of > 1 episode of hyperglycemic hyperosmolar coma or hospitalization for uncontrolled diabetes (eg, diabetic ketoacidosis); within the 6 months prior to Screening 7. Clinically significant cardiovascular and/or cerebrovascular disease within 12 months before Screening including, but not limited to unstable angina, myocardial infarction, Class III or Class IV congestive heart failure according to the New York Heart Association criteria, valvular heart disease, cardiac arrhythmia requiring treatment, pulmonary hypertension, cardiac surgery, coronary angioplasty, stroke or transient ischemic attack. 8. Patients with the following secondary complications of diabetes: i. Active proliferative retinopathy as confirmed by a dilated ophthalmoscopy (by the investigator, site ophthalmologist or an optometrist; as per standard site practice) within 6 months prior to Screening. ii. Renal dysfunction indicated by modification of diet in renal disease estimated glomerular filtration rate iii. History or presence of severe form of neuropathy or signs and symptoms of severe cardiac autonomic neuropathy. iv. Patients with non-traumatic amputation (at any time) or clinically significant vascular procedure as a complication of diabetes within 1 year prior to Screening. v. History of diabetic foot ulcer or non-healing diabetic ulcers in the 1 year prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I- To compare the efficacy of 2 doses of Insulin Tregopil versus Insulin Aspart (IAsp) in Type 2 Diabetes Mellitus (T2DM) patients who are on stable dose of metformin and insulin glargine Part II - To compare the efficacy of Insulin Tregopil versus IAsp in T2DM patients who are on stable dose of metformin and insulin glargine Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Part I: Number of severe hypoglycemia events Part II: 1. Change from Baseline in HbA1c at 12 weeks 2. patients achieving HbA1c 7% at Week 12, and Week 24; 3. Frequency of hypoglycemia events 4. Change from Baseline in weight, lipid profile 5. Change from Baseline in 60, 90, 120 mins PPG excursion 6. Safety and immunogenicity 7. Area under the glucose curve below 70 mg/dL derived from CGM Timepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactJayanti Panda
Biocon Research Limited
Outcome results
None listed