Trial Outcomes & Findings for Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus (NCT NCT01406717)
NCT ID: NCT01406717
Last Updated: 2020-08-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
360 participants
Primary outcome timeframe
24 weeks
Results posted on
2020-08-11
Participant Flow
Participant milestones
| Measure |
SPIL1033
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
|
Placebo
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
180
|
180
|
|
Overall Study
COMPLETED
|
137
|
149
|
|
Overall Study
NOT COMPLETED
|
43
|
31
|
Reasons for withdrawal
| Measure |
SPIL1033
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
|
Placebo
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
|
|---|---|---|
|
Overall Study
Subject non-compliance
|
4
|
3
|
|
Overall Study
Protocol Violation
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
14
|
8
|
|
Overall Study
Withdrawal by Subject
|
19
|
15
|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Non-completion of visit activity
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
SPIL1033
n=168 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
168 are the number of subjects in mITT population
|
Placebo
n=170 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
170 are the number of subjects in mTT population.
|
Total
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 9.26 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 9.56 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 9.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
168 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
338 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intent-to-treat
Outcome measures
| Measure |
SPIL1033
n=112 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=94 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)
|
-0.227 percentage of hemoglobin A1c (HbA1c)
Standard Error 0.243
|
-0.227 percentage of hemoglobin A1c (HbA1c)
Standard Error 0.254
|
PRIMARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
SPIL1033
n=110 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=94 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)
|
0.48 mg/dL
Standard Error 9.78
|
-5.42 mg/dL
Standard Error 10.21
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: modified intent to treat population
Outcome measures
| Measure |
SPIL1033
n=133 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=143 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Count and Percentage of Subjects Positive for Anti-exenatide Antibodies
|
59 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Evaluable population for safety: subjects who were randomized and received at least one dose of a trial medication
Outcome measures
| Measure |
SPIL1033
n=179 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=178 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The evaluable population: all mITT subjects who received at least 80% of study medication over 24 weeks and completed treatment through week 24. (modified Intent-to-treat population: .subjects who were randomized and received at least one dose of the trial medication after visit 2 (baseline) and had at least one post-baseline visit.
Outcome measures
| Measure |
SPIL1033
n=139 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=148 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change From Baseline in 2hour Postprandial Glucose (2-h PPG)
|
-21.20 mg/dl
Standard Deviation 14.50
|
-16.83 mg/dl
Standard Deviation 14.49
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The evaluable population: all mITT subjects who received at least 80% of study medication over 24 weeks and completed treatment through week 24. (modified Intent-to-treat population: .subjects who were randomized and received at least one dose of the trial medication after visit 2 (baseline) and had at least one post-baseline visit.
Outcome measures
| Measure |
SPIL1033
n=143 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=150 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change From Baseline in Triglycerides
|
1.27 mg/dl
Standard Error 16.53
|
8.39 mg/dl
Standard Error 16.53
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
SPIL1033
n=143 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=150 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change From Baseline in Low Density Lipoproteins
|
-3.18 mg/dL
Standard Error 6.12
|
0.15 mg/dL
Standard Error 6.12
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
SPIL1033
n=143 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=149 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change From Baseline in High Density Lipoproteins
|
0.64 mg/dL
Standard Error 2.16
|
0.62 mg/dL
Standard Error 2.16
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
SPIL1033
n=143 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=153 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change in Body Weight
|
-1.708 kilograms
Standard Error 0.468
|
-0.792 kilograms
Standard Error 0.467
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Evaluable Population for Efficacy
Outcome measures
| Measure |
SPIL1033
n=112 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=94 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Subjects Achieving Hemoglobin A1c (HbA1c) < 7%
|
26 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
SPIL1033
n=141 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=149 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change From Baseline in Very Low Density Lipoproteins
|
0.88 mg/dL
Standard Error 3.13
|
1.55 mg/dL
Standard Error 3.13
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
| Measure |
SPIL1033
n=168 Participants
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 112.
|
Placebo
n=170 Participants
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily. The number of subjects in evaluable population for efficacy (EPE) population are 94.
|
|---|---|---|
|
Change From Baseline in Total Cholesterol
|
-4.89 mg/dL
Standard Error 7.40
|
-0.11 mg/dL
Standard Error 7.40
|
Adverse Events
SPIL1033
Serious events: 6 serious events
Other events: 126 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 115 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPIL1033
n=180 participants at risk
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
|
Placebo
n=180 participants at risk
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
0.56%
1/180
|
0.00%
0/180
|
|
Infections and infestations
Gastroenteritis
|
0.56%
1/180
|
0.00%
0/180
|
|
Infections and infestations
Infected dermal cyst
|
0.56%
1/180
|
0.00%
0/180
|
|
Infections and infestations
Viral infection
|
0.56%
1/180
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
joint injury
|
0.56%
1/180
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.56%
1/180
|
0.00%
0/180
|
|
Infections and infestations
Road traffic accident
|
0.56%
1/180
|
0.00%
0/180
|
|
Infections and infestations
Upper limb fracture
|
0.56%
1/180
|
0.00%
0/180
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/180
|
0.56%
1/180
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.56%
1/180
|
0.00%
0/180
|
|
Ear and labyrinth disorders
Vertigo
|
0.56%
1/180
|
0.00%
0/180
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.56%
1/180
|
0.00%
0/180
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.56%
1/180
|
0.00%
0/180
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.56%
1/180
|
0.00%
0/180
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.56%
1/180
|
0.00%
0/180
|
Other adverse events
| Measure |
SPIL1033
n=180 participants at risk
SPIL1033: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
|
Placebo
n=180 participants at risk
Placebo: 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.9%
52/180
|
32.8%
59/180
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.4%
17/180
|
6.1%
11/180
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
10.6%
19/180
|
7.2%
13/180
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.1%
11/180
|
1.1%
2/180
|
|
Gastrointestinal disorders
Nausea
|
14.4%
26/180
|
5.0%
9/180
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
5/180
|
5.0%
9/180
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
10/180
|
1.7%
3/180
|
|
Nervous system disorders
Headache
|
7.2%
13/180
|
4.4%
8/180
|
|
Nervous system disorders
Dizziness
|
4.4%
8/180
|
3.3%
6/180
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
5/180
|
1.7%
3/180
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.7%
3/180
|
2.2%
4/180
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER