Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects (NCT NCT06473662)
NCT ID: NCT06473662
Last Updated: 2025-02-06
Results Overview
Change in HbA1c Relative to Baseline at Start of Study
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
153 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-02-06
Participant Flow
204 patients were assessed for eligibility - 51 did not meet the inclusion criteria. Recruitment was conducted in hospital clinics and commenced one month before the start of study in October 2018
153 patients were randomised to allocated treatment groups. A proportion of these patients (7) did not commence treatment, and full baseline characteristics were not collected for the whole group
Participant milestones
| Measure |
75iu
Capsule containing 75iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
150iu
Capsule containing 150iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
300iu
Capsule containing 300iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
52
|
|
Overall Study
COMPLETED
|
33
|
29
|
38
|
|
Overall Study
NOT COMPLETED
|
18
|
21
|
14
|
Reasons for withdrawal
| Measure |
75iu
Capsule containing 75iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
150iu
Capsule containing 150iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
300iu
Capsule containing 300iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
5
|
|
Overall Study
Uncontrolled hyperglycaemia
|
1
|
2
|
2
|
|
Overall Study
Starting HbA1c below 7%
|
0
|
1
|
1
|
|
Overall Study
No data from Central lab (protocol violation)
|
14
|
9
|
4
|
|
Overall Study
Did not take medication
|
2
|
3
|
2
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of Oral Insulin Formulation in Type 2 Diabetes Mellitus Subjects
Baseline characteristics by cohort
| Measure |
75iu
n=33 Participants
Capsule containing 75iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
150iu
n=29 Participants
Capsule containing 150iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
300iu
n=38 Participants
Capsule containing 300iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
100 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Customized
|
48.8 years
STANDARD_DEVIATION 6.4 • n=99 Participants
|
46.6 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
49.7 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
48.5 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
100 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
India
|
33 participants
n=99 Participants
|
29 participants
n=107 Participants
|
38 participants
n=206 Participants
|
100 participants
n=7 Participants
|
|
HbA1c (%)
|
8.27 %
STANDARD_DEVIATION 0.66 • n=99 Participants
|
8.13 %
STANDARD_DEVIATION 0.65 • n=107 Participants
|
7.93 %
STANDARD_DEVIATION 0.61 • n=206 Participants
|
8.1 %
STANDARD_DEVIATION 0.65 • n=7 Participants
|
|
Body weight (kg)
|
63.9 kg
STANDARD_DEVIATION 8.3 • n=99 Participants
|
66.1 kg
STANDARD_DEVIATION 8.8 • n=107 Participants
|
66.9 kg
STANDARD_DEVIATION 12.5 • n=206 Participants
|
65.7 kg
STANDARD_DEVIATION 10.2 • n=7 Participants
|
|
BMI (kg/m2)
|
25.6 kg/m2
STANDARD_DEVIATION 3.0 • n=99 Participants
|
25.8 kg/m2
STANDARD_DEVIATION 2.7 • n=107 Participants
|
25.7 kg/m2
STANDARD_DEVIATION 2.9 • n=206 Participants
|
25.7 kg/m2
STANDARD_DEVIATION 2.8 • n=7 Participants
|
|
Fasting plasma glucose (mg/dL)
|
148.8 mg/dL
STANDARD_DEVIATION 53.0 • n=99 Participants
|
148.2 mg/dL
STANDARD_DEVIATION 39.0 • n=107 Participants
|
136.7 mg/dL
STANDARD_DEVIATION 47.8 • n=206 Participants
|
144.0 mg/dL
STANDARD_DEVIATION 47.2 • n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksChange in HbA1c Relative to Baseline at Start of Study
Outcome measures
| Measure |
75iu
n=33 Participants
Capsule containing 75iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
150iu
n=29 Participants
Capsule containing 150iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
300iu
n=38 Participants
Capsule containing 300iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
|---|---|---|---|
|
Change in HbA1c
|
-0.20 % of glycated haemoglobin
Standard Deviation 1.06
|
-0.53 % of glycated haemoglobin
Standard Deviation 1.04
|
-0.31 % of glycated haemoglobin
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 12 weeksChange in Fasting Plasma Glucose Relative to Baseline at Start of Study
Outcome measures
| Measure |
75iu
n=33 Participants
Capsule containing 75iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
150iu
n=29 Participants
Capsule containing 150iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
300iu
n=38 Participants
Capsule containing 300iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose
|
-14.8 mg/dL
Standard Deviation 53.6
|
-18.8 mg/dL
Standard Deviation 39.8
|
-2.7 mg/dL
Standard Deviation 60.09
|
SECONDARY outcome
Timeframe: 12 weeksChange in Post-Prandial Glucose Relative to Baseline at Start of study
Outcome measures
| Measure |
75iu
n=33 Participants
Capsule containing 75iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
150iu
n=29 Participants
Capsule containing 150iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
300iu
n=38 Participants
Capsule containing 300iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
|---|---|---|---|
|
Change in Post-Prandial Glucose
|
-17.4 mg/dL
Standard Deviation 83.74
|
-21.0 mg/dL
Standard Deviation 86.4
|
-31.0 mg/dL
Standard Deviation 97.7
|
SECONDARY outcome
Timeframe: 12 weeksChange in Triglycerides Relative to Baseline at Start of Study
Outcome measures
| Measure |
75iu
n=33 Participants
Capsule containing 75iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
150iu
n=29 Participants
Capsule containing 150iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
300iu
n=38 Participants
Capsule containing 300iu recombinant human insulin administered two times per day
Oral insulin: Capsule administered by mouth with a glass of water two times per day, once before breakfast and once before supper
|
|---|---|---|---|
|
Changes in Triglycerides
|
-7.06 mg/dL
Standard Error 10.23
|
-22.13 mg/dL
Standard Error 11.02
|
20.56 mg/dL
Standard Error 9.61
|
Adverse Events
75iu
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
150iu
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
300iu
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place