Trial Outcomes & Findings for Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients (NCT NCT03430856)

NCT ID: NCT03430856

Last Updated: 2020-05-15

Results Overview

The primary endpoint is change from baseline in HbA1c after 24 weeks of randomized treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 143 participants
• Primary outcome timeframe: Week 0, Week 24
• Results posted on: 2020-05-15

Participant Flow

Out of 20 sites, which were selected for recruitment, 19 sites enrolled subjects in the run-in period, of which 15 sites later assigned subjects to randomized treatment: India:20 sites

The trial included an 8-week run-in period and a 24-week treatment period. During the run-in period, the subjects received insulin glargine along with metformin. In total, 143 subjects entered the run-in period, of these 52 subjects were run-in failures. Hence, 91 subjects were randomly assigned to each treatment arm.

Participant milestones

Measure	Insulin Tregopil (IN-105) - 45mg At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Insulin Tregopil (IN-105) - 30mg SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Insulin Aspart At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose
Overall Study STARTED	31	30	30
Overall Study Exposed	31	30	30
Overall Study COMPLETED	29	27	29
Overall Study NOT COMPLETED	2	3	1

Reasons for withdrawal

Measure	Insulin Tregopil (IN-105) - 45mg At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Insulin Tregopil (IN-105) - 30mg SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Insulin Aspart At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose
Overall Study Adverse Event	0	1	0
Overall Study Rescue criteria	1	1	0
Overall Study Voluntary withdrawal of consent	1	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Insulin Tregopil (IN-105) - 30mg n=30 Participants At randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Insulin Aspart n=30 Participants At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Total n=91 Participants Total of all reporting groups
Age, Continuous	52.1 Year STANDARD_DEVIATION 9.49 • n=5 Participants	50.9 Year STANDARD_DEVIATION 9.44 • n=7 Participants	54.5 Year STANDARD_DEVIATION 8.18 • n=5 Participants	52.5 Year STANDARD_DEVIATION 9.08 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	48 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants	91 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment India	31 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants	91 participants n=4 Participants
Weight	68.54 kg STANDARD_DEVIATION 11.559 • n=5 Participants	68.88 kg STANDARD_DEVIATION 9.040 • n=7 Participants	67.76 kg STANDARD_DEVIATION 9.628 • n=5 Participants	68.39 kg STANDARD_DEVIATION 10.048 • n=4 Participants
Height	158.84 cm STANDARD_DEVIATION 7.987 • n=5 Participants	158.76 cm STANDARD_DEVIATION 9.268 • n=7 Participants	158.20 cm STANDARD_DEVIATION 9.321 • n=5 Participants	158.60 cm STANDARD_DEVIATION 8.776 • n=4 Participants
BMI	27.13 kg/m^2 STANDARD_DEVIATION 3.866 • n=5 Participants	27.39 kg/m^2 STANDARD_DEVIATION 3.418 • n=7 Participants	27.13 kg/m^2 STANDARD_DEVIATION 3.667 • n=5 Participants	27.22 kg/m^2 STANDARD_DEVIATION 3.618 • n=4 Participants
Duration of T2DM	8.78 years STANDARD_DEVIATION 7.867 • n=5 Participants	7.83 years STANDARD_DEVIATION 7.715 • n=7 Participants	8.12 years STANDARD_DEVIATION 6.788 • n=5 Participants	8.25 years STANDARD_DEVIATION 7.404 • n=4 Participants
Glycosylated haemoglobin A1c	8.23 Percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.577 • n=5 Participants	8.10 Percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.670 • n=7 Participants	8.07 Percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.697 • n=5 Participants	8.13 Percentage of glycosylated haemoglobin STANDARD_DEVIATION 0.646 • n=4 Participants
OAD/Basal Insulin use at Screening Number of participants (%) Metformin alone	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
OAD/Basal Insulin use at Screening Number of participants (%) Metformin + other OADs	6 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
OAD/Basal Insulin use at Screening Number of participants (%) Metformin + OADs + Basal insulin	18 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants
OAD/Basal Insulin use at Screening Number of participants (%) Metformin - OADs + Basal insulin	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Metformin dose Number of participants (%) >=1500 mg/day	27 participants n=5 Participants	28 participants n=7 Participants	27 participants n=5 Participants	82 participants n=4 Participants
Metformin dose Number of participants (%) <1500 mg/day	4 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	9 participants n=4 Participants
Other Abnormalities, Yes or No Yes	8 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	17 participants n=4 Participants
Other Abnormalities, Yes or No No	23 participants n=5 Participants	24 participants n=7 Participants	27 participants n=5 Participants	74 participants n=4 Participants
Active proliferative retinopathy, Yes or No Yes	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Active proliferative retinopathy, Yes or No No	31 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants	91 participants n=4 Participants
OAD use evaluated at screening Alpha Glucosidase Inhibitors	2 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	9 participants n=4 Participants
OAD use evaluated at screening Biguanides	31 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants	91 participants n=4 Participants
OAD use evaluated at screening Blood Glucose Lowering Drugs, Excl. Insulins	2 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	8 participants n=4 Participants
OAD use evaluated at screening Combinations Of Oral Blood Glucose Lowering Drugs	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
OAD use evaluated at screening Dipeptidyl Peptidase 4 (Dpp-4) Inhibitors	7 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants	25 participants n=4 Participants
OAD use evaluated at screening Other Blood Glucose Lowering Drugs, Excl. Insulins	0 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants
OAD use evaluated at screening Sulfonylureas	22 participants n=5 Participants	23 participants n=7 Participants	25 participants n=5 Participants	70 participants n=4 Participants
OAD use evaluated at screening Thiazolidinediones	2 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0, Week 24

Population: The analysis of this efficacy endpoint was based on the full analysis set (FAS). FAS included all randomized subjects in Part 1. The statistical evaluation of the FAS was to follow the intention-to-treat (ITT) principle and subjects contributed to the evaluation 'as randomized'.

The primary endpoint is change from baseline in HbA1c after 24 weeks of randomized treatment.

Outcome measures

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants Strength of each tablet is 15mg 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.	Insulin Tregopil (IN-105) - 30mg n=30 Participants Strength of each tablet is 15mg 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.	Insulin Aspart n=30 Participants Pre-filled pen: 100 U/L 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
Change From Baseline in HbA1c at 24 Weeks (Part 1) Baseline (Week 0)	8.23 Percentage of glycosylated hemoglobin Standard Deviation 0.577	8.10 Percentage of glycosylated hemoglobin Standard Deviation 0.670	8.07 Percentage of glycosylated hemoglobin Standard Deviation 0.697
Change From Baseline in HbA1c at 24 Weeks (Part 1) Week 24	8.38 Percentage of glycosylated hemoglobin Standard Deviation 1.139	8.21 Percentage of glycosylated hemoglobin Standard Deviation 0.969	7.29 Percentage of glycosylated hemoglobin Standard Deviation 0.788

SECONDARY outcome

Timeframe: Week 0, Week 12

Population: This endpoint was summarized using ITT analysis set in Part I. ITT set included all randomized subjects. At Week 12, data from available participants are summarized.

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.

Outcome measures

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants Strength of each tablet is 15mg 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.	Insulin Tregopil (IN-105) - 30mg n=30 Participants Strength of each tablet is 15mg 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.	Insulin Aspart n=30 Participants Pre-filled pen: 100 U/L 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
Change From Baseline in HbA1c at Week 12 (Part 1) Baseline (Week 0)	8.23 Percentage of glycosylated haemoglobin Standard Deviation 0.577	8.10 Percentage of glycosylated haemoglobin Standard Deviation 0.670	8.07 Percentage of glycosylated haemoglobin Standard Deviation 0.697
Change From Baseline in HbA1c at Week 12 (Part 1) Week 12	8.04 Percentage of glycosylated haemoglobin Standard Deviation 0.940	8.01 Percentage of glycosylated haemoglobin Standard Deviation 0.898	7.18 Percentage of glycosylated haemoglobin Standard Deviation 0.810
Change From Baseline in HbA1c at Week 12 (Part 1) Change from Baseline	-0.17 Percentage of glycosylated haemoglobin Standard Deviation 0.913	-0.07 Percentage of glycosylated haemoglobin Standard Deviation 0.866	-0.88 Percentage of glycosylated haemoglobin Standard Deviation 0.850

SECONDARY outcome

Timeframe: Week 12, Week 24

Population: This endpoint was summarized using intention-to-treat (ITT) analysis set. ITT set included all randomized participants. At Week 12 and Week 24, data from available participants are summarized.

Number of participants achieving HbA1c < 7% at Week 12 and Week 24.

Outcome measures

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants Strength of each tablet is 15mg 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.	Insulin Tregopil (IN-105) - 30mg n=30 Participants Strength of each tablet is 15mg 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.	Insulin Aspart n=30 Participants Pre-filled pen: 100 U/L 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
Participants Achieving HbA1c < 7% (Part 1) Week 12	4 Participants	3 Participants	13 Participants
Participants Achieving HbA1c < 7% (Part 1) Week 24	2 Participants	2 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 0 through Week 24

Population: This endpoint was summarized using safety analysis set in Part I. Safety analysis set included patients who were randomized and took at least 1 dose of the study drug. Patients in the safety analysis set contributed to the evaluation 'as treated'.

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)]

Outcome measures

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants Strength of each tablet is 15mg 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.	Insulin Tregopil (IN-105) - 30mg n=30 Participants Strength of each tablet is 15mg 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.	Insulin Aspart n=30 Participants Pre-filled pen: 100 U/L 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
Percentage of Participants With Hypoglycemia Events During 24-week Treatment Period (Part 1)	26 Participants	26 Participants	25 Participants

SECONDARY outcome

Timeframe: Week 0 and Week 24

Population: This endpoint was summarized using completed participants at Week 24 and all randomised participants at Week 0 in Part I. Change from baseline was summarised using completed participants.

Change from Baseline in weight (kgs) to 24 weeks

Outcome measures

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants Strength of each tablet is 15mg 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.	Insulin Tregopil (IN-105) - 30mg n=30 Participants Strength of each tablet is 15mg 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.	Insulin Aspart n=30 Participants Pre-filled pen: 100 U/L 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
Weight (Kgs) (Part 1) Baseline (Week 0)	68.54 Kg Standard Deviation 11.559	68.88 Kg Standard Deviation 9.040	67.76 Kg Standard Deviation 9.628
Weight (Kgs) (Part 1) Week24	68.98 Kg Standard Deviation 11.837	70.15 Kg Standard Deviation 8.915	68.47 Kg Standard Deviation 9.761
Weight (Kgs) (Part 1) Change from Baseline	0.93 Kg Standard Deviation 1.212	0.30 Kg Standard Deviation 1.955	0.66 Kg Standard Deviation 1.807

SECONDARY outcome

Timeframe: 24 weeks

Population: This was planned for part 2 of the study. As part-2 of the study was discontinued, this is not applicable.

Change from Baseline in lipid profile (triglycerides, low-density lipoprotein, high-density lipoprotein, and total cholesterol) to 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0, Week 24

Population: This endpoint was summarized using the intention-to-treat (ITT) analysis set from Part I. ITT set included all randomized participants. At Week 24, data from available participants are summarized.

Change from Baseline in the mean 60, 90, 120 minutes PPG excursions assessed from standardized test meal at Week 24.

Outcome measures

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants Strength of each tablet is 15mg 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.	Insulin Tregopil (IN-105) - 30mg n=30 Participants Strength of each tablet is 15mg 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.	Insulin Aspart n=30 Participants Pre-filled pen: 100 U/L 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
Post-prandial Glucose (PPG) Excursion (Part 1) Week 0, 60 min	79.5 mg/dL Standard Deviation 45.53	98.3 mg/dL Standard Deviation 41.94	74.4 mg/dL Standard Deviation 42.85
Post-prandial Glucose (PPG) Excursion (Part 1) Week 0, 90 min	92.4 mg/dL Standard Deviation 47.94	106.4 mg/dL Standard Deviation 35.39	90.8 mg/dL Standard Deviation 35.35
Post-prandial Glucose (PPG) Excursion (Part 1) Week 0, 120 min	100.9 mg/dL Standard Deviation 58.18	113.5 mg/dL Standard Deviation 53.45	93.7 mg/dL Standard Deviation 41.20
Post-prandial Glucose (PPG) Excursion (Part 1) Week 24, 60 min	35.8 mg/dL Standard Deviation 44.26	32.7 mg/dL Standard Deviation 45.13	55.1 mg/dL Standard Deviation 34.57
Post-prandial Glucose (PPG) Excursion (Part 1) Week 24, 90 min	53.8 mg/dL Standard Deviation 45.38	47.2 mg/dL Standard Deviation 44.84	66.3 mg/dL Standard Deviation 36.13
Post-prandial Glucose (PPG) Excursion (Part 1) Week 24, 120 min	64.1 mg/dL Standard Deviation 51.87	50.2 mg/dL Standard Deviation 44.23	65.5 mg/dL Standard Deviation 34.58

SECONDARY outcome

Timeframe: 24 weeks

Population: This endpoint was summarized using Treatment Emergent Adverse Events - Safety Analysis Set (Part I).

Includes participants who have experienced at least one treatment emergent adverse events over 24 weeks

Outcome measures

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants Strength of each tablet is 15mg 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.	Insulin Tregopil (IN-105) - 30mg n=30 Participants Strength of each tablet is 15mg 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.	Insulin Aspart n=30 Participants Pre-filled pen: 100 U/L 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
Number of Participants With Treatment-Emergent Adverse Events (Part 1)	5 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: This was planned for part 2 of the study. As part-2 of the study was discontinued, this is not applicable.

Incidence and change from baseline in the relative levels of anti-drug antibody levels over 24 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: This was planned for part 2 of the study. As part-2 of the study was discontinued, this is not applicable.

Area under the glucose curve below 70 mg/dL derived from CGM, applicable for only part II study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12, Week 24

Population: This endpoint was summarized using intention-to-treat (ITT) analysis set in Part I. ITT set included all randomized participants. At Week 12 and Week 24, data from available participant are summarized.

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.

Outcome measures

Measure	Insulin Tregopil (IN-105) - 45mg n=31 Participants Strength of each tablet is 15mg 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.	Insulin Tregopil (IN-105) - 30mg n=30 Participants Strength of each tablet is 15mg 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.	Insulin Aspart n=30 Participants Pre-filled pen: 100 U/L 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
Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24 Week 12	4 Participants	3 Participants	11 Participants
Participants Achieving HbA1c < 7% Without Reported Clinically Significant or Severe Hypoglycemic Event Between End of Week 8 and Week 24 Week 24	1 Participants	3 Participants	7 Participants

Adverse Events

Insulin Tregopil (IN-105) - 45mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Insulin Tregopil (IN-105) - 30mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Insulin Aspart

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Insulin Tregopil (IN-105) - 45mg n=31 participants at risk At randomization, all subjects started on 45 mg mealtime insulin Tregopil (oral) in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Insulin Tregopil (IN-105) - 30mg n=30 participants at risk SAt randomization, all subjects started on 30 mg mealtime insulin Tregopil in combination with insulin glargine (basal insulin, SC, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin Tregopil was administered (oral) 10 minutes prior to each main meal, was titrated to the 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered once/twice weekly in the initial 4 weeks, based on the 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose.	Insulin Aspart n=30 participants at risk At randomization, all subjects started on 4 units of mealtime insulin aspart (bolus insulin) in combination with insulin glargine (basal insulin, once or twice daily) and metformin (oral) in a basal-bolus regimen. Insulin aspart was administered (sc) 0-5 minutes before each main meal, was titrated to the pre-prandial glycaemic target of 71-129 mg/dL and 2-hour PPG target of 141-179 mg/dL according to the titration algorithm. Dose adjustments were considered daily based on the pre-prandial and 2-hour SMPG on the previous week. Basal insulin and metformin treatment continued without changing the frequency or dose
Nervous system disorders Hypoaesthesia	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Nervous system disorders Lethargy	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Gastrointestinal disorders Gastritis	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Gastrointestinal disorders Nausea	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
General disorders Pyrexia	3.2% 1/31 • Number of events 2 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
General disorders Pain	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Infections and infestations Urinary tract infection	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Infections and infestations Dysentery	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Infections and infestations Upper respiratory tract infection	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Infections and infestations Urinary tract infection viral	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Injury, poisoning and procedural complications Fall	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Injury, poisoning and procedural complications Vulval laceration	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Investigations Blood creatinine increased	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Investigations Haemoglobin decreased	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Investigations Hepatic enzyme increased	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Investigations Weight increased	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 1/31 • Number of events 2 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Musculoskeletal and connective tissue disorders Back pain	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Nervous system disorders Dizziness	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Nervous system disorders Paraesthesia	3.2% 1/31 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Renal and urinary disorders Nephrolithiasis	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Renal and urinary disorders Vascular disorders	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.
Renal and urinary disorders Hypertension	0.00% 0/31 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	0.00% 0/30 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.	3.3% 1/30 • Number of events 1 • From the date on or after first day of exposure to randomized treatment until the last day of randomized treatment, an average of 24 weeks. Safety analysis set was used for the assessment of safety including AEs. The safety analysis set included all subjects who received at least one dose of test product.

Additional Information

Dr. Subramanian L

Biocon Research limited

Phone: 080-28082808

Email: subramanian.l101@biocon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place