- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03430856
Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 560010
- Diacon Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Insulin Tregopil (IN-105) - 45mg
Strength of each tablet is 15mg
|
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 Names:
|
EXPERIMENTAL: Insulin Tregopil (IN-105) - 30mg
Strength of each tablet is 15mg
|
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 Names:
|
ACTIVE_COMPARATOR: Insulin Aspart
Pre-filled pen: 100 U/L
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c at 24 Weeks (Part 1)
Time Frame: Week 0, Week 24
|
The primary endpoint is change from baseline in HbA1c after 24 weeks of randomized treatment.
|
Week 0, Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in HbA1c at Week 12 (Part 1)
Time Frame: 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.
|
Week 0, Week 12
|
Participants Achieving HbA1c < 7% (Part 1)
Time Frame: Week 12, Week 24
|
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)
Time Frame: 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)]
|
Week 0 through Week 24
|
Weight (Kgs) (Part 1)
Time Frame: Week 0 and Week 24
|
Change from Baseline in weight (kgs) to 24 weeks
|
Week 0 and Week 24
|
Lipid Profile (Part 1)
Time Frame: 24 weeks
|
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)
Time Frame: Week 0, Week 24
|
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)
Time Frame: 24 weeks
|
Includes participants who have experienced at least one treatment emergent adverse events over 24 weeks
|
24 weeks
|
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
|
24 weeks
|
CGM
Time Frame: 24 weeks
|
Area under the glucose curve below 70 mg/dL derived from CGM, applicable for only part II study
|
24 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24
Time Frame: Week 12, 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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Subramanian Loganathan, MD, Biocon Research Limited
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TREGO-DM2-03-I-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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