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Clinical Trial Details

Trial ID: L6291
Source ID: NCT03430856
Associated Drug: Insulin Tregopil
Title: Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03430856/results
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Insulin Tregopil|DRUG: Insulin Aspart
Outcome Measures: Primary: Change From Baseline in HbA1c at 24 Weeks (Part 1), The primary endpoint is change from baseline in HbA1c after 24 weeks of randomized treatment., Week 0, Week 24 | Secondary: Change From Baseline in HbA1c at Week 12 (Part 1), This secondary outcome is the change from baseline in HbA1c after 12 weeks of randomized treatment. For this endpoint baseline (Week 0) and Week 12 have been presented., Week 0, Week 12|Participants Achieving HbA1c < 7% (Part 1), Number of participants achieving HbA1c \< 7% at Week 12 and Week 24., Week 12, Week 24|Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1), A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter \[mg/dL (3.9 millimoles/liter (mmol/L)\], Week 0 through Week 24|Weight (Kgs) (Part 1), Change from Baseline in weight (kgs) to 24 weeks, Week 0 and Week 24|Lipid Profile (Part 1), Change from Baseline in lipid profile (triglycerides, low-density lipoprotein, high-density lipoprotein, and total cholesterol) to 24 weeks, 24 weeks|Post-prandial Glucose (PPG) Excursion (Part 1), Change from Baseline in the mean 60, 90, 120 minutes PPG excursions assessed from standardized test meal at Week 24., Week 0, Week 24|Number of Participants With Treatment-Emergent Adverse Events (Part 1), Includes participants who have experienced at least one treatment emergent adverse events over 24 weeks, 24 weeks|Anti-drug Antibody Levels, Incidence and change from baseline in the relative levels of anti-drug antibody levels over 24 weeks, 24 weeks|CGM, Area under the glucose curve below 70 mg/dL derived from CGM, applicable for only part II study, 24 weeks | Other: Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24, Number of participants achieving HbA1c \< 7% at Week 12 and Week 24 without reported clinically significant or severe hypoglycemic events between end of Week 8 and Week 24., Week 12, Week 24
Sponsor/Collaborators: Sponsor: Biocon Limited
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 143
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2017-12-26
Completion Date: 2019-02-20
Results First Posted: 2020-05-15
Last Update Posted: 2020-05-15
Locations: Diacon Hospital, Bangalore, Karnataka, 560010, India
URL: https://clinicaltrials.gov/show/NCT03430856