Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Insulin Tregopil; Insulin Aspart
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Insulin Tregopil (IN-105) Mode of Administration: To be administered orally 10 ± 2 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit.; Drug: Insulin Aspart Mode of Administration: To be administered within 5 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit
Other intervention name(s): IN-105
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study is conducted in two parts. Part I has 3 arms and Part 2 has 2 arms.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral insulin