Trial Outcomes & Findings for Study of AC-201 in Patients With Type 2 Diabetes Mellitus (NCT NCT01276106)
NCT ID: NCT01276106
Last Updated: 2018-05-22
Results Overview
For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p\<0.05.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
259 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-05-22
Participant Flow
The participants were recruited in 21 study centers, which were located in 2 countries (USA and Taiwan)
Participant milestones
| Measure |
AC-201, 25mg BID
AC-201: Capsule, 25mg BID
|
AC-201, 50mg BID
AC-201: Capsule, 50mg BID
|
AC-201, 75mg BID
AC-201: Capsule, 75mg BID
|
Placebo
Placebo: Capsule, BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
64
|
65
|
65
|
|
Overall Study
COMPLETED
|
53
|
55
|
49
|
52
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
16
|
13
|
Reasons for withdrawal
| Measure |
AC-201, 25mg BID
AC-201: Capsule, 25mg BID
|
AC-201, 50mg BID
AC-201: Capsule, 50mg BID
|
AC-201, 75mg BID
AC-201: Capsule, 75mg BID
|
Placebo
Placebo: Capsule, BID
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
11
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
1
|
6
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
2
|
|
Overall Study
Insufficient therapeutic effects
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study of AC-201 in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
AC-201, 25mg BID
n=65 Participants
AC-201: Capsule, 25mg BID
|
AC-201, 50mg BID
n=64 Participants
AC-201: Capsule, 50mg BID
|
AC-201, 75mg BID
n=65 Participants
AC-201: Capsule, 75mg BID
|
Placebo
n=65 Participants
Placebo: Capsule, BID
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 9 • n=99 Participants
|
55 years
STANDARD_DEVIATION 9 • n=107 Participants
|
57 years
STANDARD_DEVIATION 9 • n=206 Participants
|
55 years
STANDARD_DEVIATION 8 • n=7 Participants
|
56 years
STANDARD_DEVIATION 9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
131 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
128 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
37 participants
n=107 Participants
|
38 participants
n=206 Participants
|
37 participants
n=7 Participants
|
150 participants
n=31 Participants
|
|
Region of Enrollment
Taiwan
|
27 participants
n=99 Participants
|
27 participants
n=107 Participants
|
27 participants
n=206 Participants
|
28 participants
n=7 Participants
|
109 participants
n=31 Participants
|
|
HbA1c
|
8.4 %
STANDARD_DEVIATION 0.6 • n=99 Participants
|
8.3 %
STANDARD_DEVIATION 0.7 • n=107 Participants
|
8.5 %
STANDARD_DEVIATION 0.7 • n=206 Participants
|
8.4 %
STANDARD_DEVIATION 0.7 • n=7 Participants
|
8.4 %
STANDARD_DEVIATION 0.7 • n=31 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: The Full Analysis Set included all randomized patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline HbA1c assessment.
For efficacy analyses, the primary analysis was at Week 24 Endpoint, defined as the last valid post-baseline measurement taken at or before Week 24. Efficacy results for treatment groups were considered statistically significant if change from baseline relative to placebo had p\<0.05.
Outcome measures
| Measure |
AC-201, 25mg BID
n=63 Participants
AC-201: Capsule, 25mg BID
|
AC-201, 50mg BID
n=61 Participants
AC-201: Capsule, 50mg BID
|
AC-201, 75mg BID
n=62 Participants
AC-201: Capsule, 75mg BID
|
Placebo
n=63 Participants
Placebo: Capsule, BID
|
|---|---|---|---|---|
|
Change in HbA1c From Baseline
|
0.03 percentage points
Standard Error 0.123
|
-0.07 percentage points
Standard Error 0.126
|
-0.13 percentage points
Standard Error 0.125
|
0.22 percentage points
Standard Error 0.123
|
Adverse Events
AC-201, 25mg BID
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
AC-201, 50mg BID
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
AC-201, 75mg BID
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AC-201, 25mg BID
n=65 participants at risk
AC-201: Capsule, 25mg BID
|
AC-201, 50mg BID
n=64 participants at risk
AC-201: Capsule, 50mg BID
|
AC-201, 75mg BID
n=65 participants at risk
AC-201: Capsule, 75mg BID
|
Placebo
n=65 participants at risk
Placebo: Capsule, BID
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatitis
|
1.5%
1/65 • Number of events 1 • 24 weeks
|
0.00%
0/64 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Renal and urinary disorders
Renal Mass
|
1.5%
1/65 • Number of events 1 • 24 weeks
|
0.00%
0/64 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Gastrointestinal disorders
Gastric Ulcer Hemorrhage
|
1.5%
1/65 • Number of events 1 • 24 weeks
|
0.00%
0/64 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/65 • 24 weeks
|
1.6%
1/64 • Number of events 1 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/65 • 24 weeks
|
1.6%
1/64 • Number of events 1 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/65 • 24 weeks
|
1.6%
1/64 • Number of events 2 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Reproductive system and breast disorders
Breast Cancer
|
0.00%
0/65 • 24 weeks
|
0.00%
0/64 • 24 weeks
|
1.5%
1/65 • Number of events 1 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/65 • 24 weeks
|
0.00%
0/64 • 24 weeks
|
1.5%
1/65 • Number of events 1 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Renal and urinary disorders
Stress Urinary Incontenence
|
0.00%
0/65 • 24 weeks
|
0.00%
0/64 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
1.5%
1/65 • Number of events 1 • 24 weeks
|
Other adverse events
| Measure |
AC-201, 25mg BID
n=65 participants at risk
AC-201: Capsule, 25mg BID
|
AC-201, 50mg BID
n=64 participants at risk
AC-201: Capsule, 50mg BID
|
AC-201, 75mg BID
n=65 participants at risk
AC-201: Capsule, 75mg BID
|
Placebo
n=65 participants at risk
Placebo: Capsule, BID
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
18.5%
12/65 • Number of events 14 • 24 weeks
|
15.6%
10/64 • Number of events 12 • 24 weeks
|
32.3%
21/65 • Number of events 25 • 24 weeks
|
9.2%
6/65 • Number of events 7 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory Tract Infection
|
12.3%
8/65 • Number of events 9 • 24 weeks
|
15.6%
10/64 • Number of events 14 • 24 weeks
|
6.2%
4/65 • Number of events 4 • 24 weeks
|
9.2%
6/65 • Number of events 6 • 24 weeks
|
|
Renal and urinary disorders
Chromatouria
|
3.1%
2/65 • Number of events 2 • 24 weeks
|
7.8%
5/64 • Number of events 5 • 24 weeks
|
20.0%
13/65 • Number of events 13 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.6%
3/65 • Number of events 3 • 24 weeks
|
4.7%
3/64 • Number of events 4 • 24 weeks
|
6.2%
4/65 • Number of events 6 • 24 weeks
|
1.5%
1/65 • Number of events 1 • 24 weeks
|
|
Nervous system disorders
Headache
|
1.5%
1/65 • Number of events 1 • 24 weeks
|
3.1%
2/64 • Number of events 2 • 24 weeks
|
6.2%
4/65 • Number of events 4 • 24 weeks
|
3.1%
2/65 • Number of events 3 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/65 • 24 weeks
|
0.00%
0/64 • 24 weeks
|
6.2%
4/65 • Number of events 4 • 24 weeks
|
3.1%
2/65 • Number of events 2 • 24 weeks
|
|
Nervous system disorders
Back Pain
|
0.00%
0/65 • 24 weeks
|
1.6%
1/64 • Number of events 1 • 24 weeks
|
6.2%
4/65 • Number of events 5 • 24 weeks
|
0.00%
0/65 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60