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

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ClinicalTrials.gov Identifier: NCT03430856
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Type2 Diabetes Mellitus Drug: Insulin Tregopil Drug: Insulin Aspart Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
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)
Masking Description: Open Label Trial
Primary Purpose: Treatment
Official Title: An Open Label, Multi-center, Randomized, Parallel Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Insulin Tregopil (IN-105) Compared With Insulin Aspart in the Treatment of Patients With Type 2 Diabetes Mellitus on Stable Dose of Metformin and Insulin Glargine
Actual Study Start Date : December 26, 2017
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin Tregopil (IN-105) - 45mg
Strength of each tablet is 15mg
Drug: Insulin Tregopil
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.
Other Name: IN-105

Experimental: Insulin Tregopil (IN-105) - 30mg
Strength of each tablet is 15mg
Drug: Insulin Tregopil
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.
Other Name: IN-105

Active Comparator: Insulin Aspart
Pre-filled pen: 100 U/L
Drug: Insulin Aspart
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




Primary Outcome Measures :
  1. Change from Baseline in HbA1c at 24 weeks (Part I and Part II) [ Time Frame: 24 weeks ]
    The primary endpoint is change from baseline in HbA1c after 24 weeks of randomised treatment.


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
    Change from Baseline in HbA1c (%) at 12 weeks

  2. HbA1c < 7% [ Time Frame: 12, 24 weeks ]
    Patients achieving HbA1c < 7% at Week 12, and Week 24

  3. Hypoglycemia [ Time Frame: 24 weeks ]
    Frequency of hypoglycemia events

  4. Weight (kgs) [ Time Frame: 24 weeks ]
    Change from Baseline in weight (kgs) to 24 weeks

  5. Lipid profile [ Time Frame: 24 weeks ]
    5. Change from Baseline in lipid profile (triglycerides, low-density lipoprotein, high-density lipoprotein, and total cholesterol) to 24 weeks

  6. PPG [ Time Frame: 24 weeks ]
    Change from Baseline in 60, 90, 120 mins PPG excursion

  7. Adverse events [ Time Frame: 24 weeks ]
    Incidence and Severity of adverse events over 24 weeks

  8. Anti-drug antibody levels [ Time Frame: 24 weeks ]
    Incidence and change from baseline in the relative levels of anti-drug antibody levels over 24 weeks

  9. CGM [ Time Frame: 24 weeks ]
    Area under the glucose curve below 70 mg/dL derived from CGM, applicable for only part II study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  • 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).
  • 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
  • Eligible for initiation of or already receiving insulin glargine
  • Hemoglobin ≥ 10.0 g/Dl
  • HbA1c of 7.5% to 10.0 %
  • Body mass index of 18.5 to 35.0 kg/m2

Key Exclusion Criteria

  • Patients with T1DM
  • Treatment with glucagon-like peptide 1 agonists within 12 weeks prior to Screening
  • Ongoing treatment with OADs (eg, Thiazolidinediones) contraindicated or unapproved for combination treatment with insulin
  • 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
  • History of ≥2 episodes of severe hypoglycemia (as per ADA 2017) within the 6 months before Screening
  • History of > 1 episode of hyperglycemic hyperosmolar coma or hospitalization for uncontrolled diabetes (eg, diabetic ketoacidosis); within the 6 months prior to Screening
  • 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.
  • 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 < 45 mL/min/1.73 m2 and/or diabetic nephropathy and/or clinical nephrotic syndrome at Screening. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430856


Locations
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India
Diacon Hospital
Bangalore, Karnataka, India, 560010
Sponsors and Collaborators
Biocon Limited
Investigators
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Study Director: Subramanian Loganathan, MD Biocon Research Limited

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Responsible Party: Biocon Limited
ClinicalTrials.gov Identifier: NCT03430856     History of Changes
Other Study ID Numbers: TREGO-DM2-03-I-01
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biocon Limited:
Oral insulin
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs