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

NCT03430856 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: TREGO-DM2-03-I-01
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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

Conditions

Type2 Diabetes Mellitus

Keywords

Oral insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change From Baseline in HbA1c at Week 12 (Part 1)

  Week 0, Week 12

• Participants Achieving HbA1c < 7% (Part 1)

  Week 12, Week 24

• Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1)

  Week 0 through Week 24

• Weight (Kgs) (Part 1)

  Week 0 and Week 24

• Lipid Profile (Part 1)

  24 weeks

Other Outcomes (1)

• Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24

  Week 12, Week 24

Study Arms (3)

Insulin Tregopil (IN-105) - 45mg

EXPERIMENTAL

Strength of each tablet is 15mg

Drug: Insulin Tregopil

Insulin Tregopil (IN-105) - 30mg

EXPERIMENTAL

Strength of each tablet is 15mg

Drug: Insulin Tregopil

Insulin Aspart

ACTIVE COMPARATOR

Pre-filled pen: 100 U/L

Drug: Insulin Aspart

Interventions

Insulin Tregopil DRUG

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.

Also known as: IN-105

Insulin Tregopil (IN-105) - 30mg; Insulin Tregopil (IN-105) - 45mg

Insulin Aspart DRUG

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

Insulin Aspart

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocon Limited: lead

Study Sites (1)

Diacon Hospital

Bangalore, Karnataka, 560010, India

Location

Related Publications (1)

• Lebovitz HE, Fleming A, Cherrington AD, Joshi S, Athalye SN, Loganathan S, Vishweswaramurthy A, Panda J, Marwah A. Efficacy and safety of Tregopil, a novel, ultra-rapid acting oral prandial insulin analog, as part of a basal-bolus regimen in type 2 diabetes: a randomized, active-controlled phase 2/3 study. Expert Opin Pharmacother. 2022 Nov;23(16):1855-1863. doi: 10.1080/14656566.2022.2141569. Epub 2022 Nov 9.

  PMID: 36352762 DERIVED

MeSH Terms

Interventions

Indium-105; Insulin Aspart

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Subramanian L
• Organization: Biocon Research limited

subramanian.l101@biocon.com

080-28082808

Study Officials

• Subramanian Loganathan, MD

  Biocon Research Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label Trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study is conducted in two parts. Part I has 3 arms and Part 2 has 2 arms.

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: February 13, 2018
• Study Start: December 26, 2017
• Primary Completion: February 6, 2019
• Study Completion: February 20, 2019
• Last Updated: May 15, 2020
• Results First Posted: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)