Trial Outcomes & Findings for Long-term Study of KAD-1229 in Type 2 Diabetes Patients (NCT NCT01333592)
NCT ID: NCT01333592
Last Updated: 2014-12-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
52 weeks
Results posted on
2014-12-15
Participant Flow
Participant milestones
| Measure |
KAD-1229 / DPP-4 Inhibitors
|
KAD-1229 / Biguanides
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
69
|
|
Overall Study
COMPLETED
|
58
|
52
|
|
Overall Study
NOT COMPLETED
|
9
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Study of KAD-1229 in Type 2 Diabetes Patients
Baseline characteristics by cohort
| Measure |
KAD-1229 / DPP-4 Inhibitors
n=67 Participants
|
KAD-1229 / Biguanides
n=68 Participants
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
HbA1c
|
7.47 %
STANDARD_DEVIATION 0.54 • n=5 Participants
|
7.50 %
STANDARD_DEVIATION 0.66 • n=7 Participants
|
7.49 %
STANDARD_DEVIATION 0.60 • n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksOutcome measures
| Measure |
KAD-1229 / DPP-4 Inhibitors
n=67 Participants
|
KAD-1229 / Biguanides
n=69 Participants
|
|---|---|---|
|
Incidences of Adverse Events
|
48 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: at week 0 and week 52Outcome measures
| Measure |
KAD-1229 / DPP-4 Inhibitors
n=58 Participants
|
KAD-1229 / Biguanides
n=53 Participants
|
|---|---|---|
|
Change From Baseline in HbA1c at 52 Weeks
|
-0.45 percentage of HbA1c
Standard Deviation 0.69
|
-0.28 percentage of HbA1c
Standard Deviation 0.63
|
Adverse Events
KAD-1229 / DPP-4 Inhibitors
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
KAD-1229 / Biguanides
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KAD-1229 / DPP-4 Inhibitors
n=67 participants at risk
|
KAD-1229 / Biguanides
n=69 participants at risk
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
large intestine carcinoma
|
1.5%
1/67
|
1.4%
1/69
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.00%
0/67
|
1.4%
1/69
|
|
Cardiac disorders
acute myocardial infarction
|
0.00%
0/67
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
traumatic lung injury
|
0.00%
0/67
|
1.4%
1/69
|
|
Gastrointestinal disorders
colonic polyp
|
0.00%
0/67
|
1.4%
1/69
|
|
Injury, poisoning and procedural complications
brain contusion
|
0.00%
0/67
|
1.4%
1/69
|
|
Injury, poisoning and procedural complications
lumbar vertebral fracture
|
0.00%
0/67
|
1.4%
1/69
|
|
Injury, poisoning and procedural complications
rib fracture
|
0.00%
0/67
|
1.4%
1/69
|
|
Injury, poisoning and procedural complications
skull fracture
|
0.00%
0/67
|
1.4%
1/69
|
Other adverse events
| Measure |
KAD-1229 / DPP-4 Inhibitors
n=67 participants at risk
|
KAD-1229 / Biguanides
n=69 participants at risk
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
3.0%
2/67
|
11.6%
8/69
|
|
Infections and infestations
Nasopharyngitis
|
25.4%
17/67
|
43.5%
30/69
|
|
Infections and infestations
Pharyngitis
|
9.0%
6/67
|
2.9%
2/69
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.5%
5/67
|
7.2%
5/69
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/67
|
5.8%
4/69
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
4/67
|
1.4%
1/69
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
4/67
|
1.4%
1/69
|
|
Investigations
Alanine aminotransferase increase
|
0.00%
0/67
|
7.2%
5/69
|
|
Investigations
γ-glutamyltransferase increase
|
6.0%
4/67
|
10.1%
7/69
|
|
Investigations
Blood urine present
|
0.00%
0/67
|
5.8%
4/69
|
|
Investigations
White blood cell count increase
|
4.5%
3/67
|
7.2%
5/69
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place