Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients

Phase 2

Completed

Conditions: Type2 Diabetes Mellitus

Interventions: Drug: Insulin Aspart
Drug: Insulin Tregopil

Registration Number: NCT03430856

Lead Sponsor: Biocon Limited

Brief Summary: This is an open label Phase II/III study to evaluate the efficacy and safety of test drug, Insulin Tregopil (IN-105) compared with Insulin Aspart (IAsp) in Type 2 Diabetes Mellitus patients. on stable dose of Metformin and insulin Glargine. The study will be conducted in 2 parts, Part I and Part II. The study duration will be approximately 37 weeks for Part I and for Part II of the study respectively

Detailed Description: Part I of the study is a Phase II multi-center, randomized, open label clinical study to evaluate the efficacy and safety of Insulin Tregopil (2 dose levels: 30 mg, 45 mg) compared with IAsp in the treatment of T2DM patients. Part II of the study is the Phase III, multi-center, randomized, open label clinical study to evaluate the efficacy and safety of Insulin Tregopil (30 mg or 45 mg based upon the outcome of Part I data) compared with IAsp in the treatment of T2DM patients. For Part I and Part II, the study duration will be approximately 37 weeks (3 weeks Screening, 8 weeks Run-in, 24 weeks Treatment, 2 weeks Safety follow-up). An Independent Data and Safety Monitoring Board (DSMB) will evaluate the data from Part I of the study. Part II of the study will be initiated after approval from the office of Drugs Controller General of India (DCGI) and Data Safety Monitoring Board (DSMB) recommendation based on review of data from Part I of the study. In both Part I and Part II of the study, T2DM patients with glycated hemoglobin (HbA1c) 7.5 to 10% (both inclusive), on stable dose of metformin ± oral antidiabetic drugs (OADs) ± basal insulin who are eligible for insulin glargine administration as per investigator discretion and who satisfy the selection criteria will be enrolled. The eligible patients will go through a Run-in period of 8 weeks. At the end of 8 weeks Run-in period, eligibility will be checked and patients will enter the treatment period of 24 weeks and will be allocated to 3 treatment arms (Part I) or randomized to 2 treatment arms (Part II); if found eligible for randomization. A total of 90 patients in part 1 and 268 patients in part 2 will be randomised to the treatment arms from approximately 40 centers in India.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 143

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Aspart	Insulin Aspart	Pre-filled pen: 100 U/L
Insulin Tregopil (IN-105) - 45mg	Insulin Tregopil	Strength of each tablet is 15mg
Insulin Tregopil (IN-105) - 30mg	Insulin Tregopil	Strength of each tablet is 15mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c at 24 Weeks (Part 1)	Week 0, Week 24	The primary endpoint is change from baseline in HbA1c after 24 weeks of randomized treatment.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1)	Week 0 through Week 24	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 \[mg/dL (3.9 millimoles/liter (mmol/L)\]
Post-prandial Glucose (PPG) Excursion (Part 1)	Week 0, Week 24	Change from Baseline in the mean 60, 90, 120 minutes PPG excursions assessed from standardized test meal at Week 24.
Number of Participants With Treatment-Emergent Adverse Events (Part 1)	24 weeks	Includes participants who have experienced at least one treatment emergent adverse events over 24 weeks
Change From Baseline in HbA1c at Week 12 (Part 1)	Week 0, Week 12	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.
Participants Achieving HbA1c < 7% (Part 1)	Week 12, Week 24	Number of participants achieving HbA1c \< 7% at Week 12 and Week 24.
CGM	24 weeks	Area under the glucose curve below 70 mg/dL derived from CGM, applicable for only part II study
Weight (Kgs) (Part 1)	Week 0 and Week 24	Change from Baseline in weight (kgs) to 24 weeks
Lipid Profile (Part 1)	24 weeks	Change from Baseline in lipid profile (triglycerides, low-density lipoprotein, high-density lipoprotein, and total cholesterol) to 24 weeks
Anti-drug Antibody Levels	24 weeks	Incidence and change from baseline in the relative levels of anti-drug antibody levels over 24 weeks