Trial Outcomes & Findings for Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus (NCT NCT02154347)

NCT ID: NCT02154347

Last Updated: 2019-09-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

178 participants

Primary outcome timeframe

16 weeks

Results posted on

2019-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo/KAD-1229 Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study. KAD-1229 Placebo Insulin	KAD-1229/KAD-1229 Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. KAD-1229 Insulin
Double-blind Period STARTED	60	118
Double-blind Period COMPLETED	57	114
Double-blind Period NOT COMPLETED	3	4
Open-label Period STARTED	57	113
Open-label Period COMPLETED	50	88
Open-label Period NOT COMPLETED	7	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/KAD-1229 Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study. KAD-1229 Placebo Insulin	KAD-1229/KAD-1229 Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. KAD-1229 Insulin
Double-blind Period Adverse Event	1	2
Double-blind Period Lack of Efficacy	1	0
Double-blind Period Physician Decision	0	1
Double-blind Period Withdrawal by Subject	1	1
Open-label Period Adverse Event	3	4
Open-label Period Lack of Efficacy	4	19
Open-label Period Protocol Violation	0	1
Open-label Period Withdrawal by Subject	0	1

Baseline Characteristics

Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/KAD-1229 n=60 Participants Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study. KAD-1229 Placebo Insulin	KAD-1229/KAD-1229 n=118 Participants Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. KAD-1229 Insulin	Total n=178 Participants Total of all reporting groups
Age, Continuous	56.5 years STANDARD_DEVIATION 11.7 • n=5 Participants	59.7 years STANDARD_DEVIATION 10.3 • n=7 Participants	58.6 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	39 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	79 Participants n=7 Participants	130 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	60 Participants n=5 Participants	118 Participants n=7 Participants	178 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
HbA1c	8.54 % STANDARD_DEVIATION 0.85 • n=5 Participants	8.48 % STANDARD_DEVIATION 0.70 • n=7 Participants	8.50 % STANDARD_DEVIATION 0.75 • n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: full analysis set

Outcome measures

Outcome measures
Measure	Placebo/KAD-1229 n=60 Participants Patients are administered Placebo for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with Insulin throughout the study. KAD-1229 Placebo Insulin	KAD-1229/KAD-1229 n=118 Participants Patients are administered KAD-1229 for 16 weeks (double-blind period), followed by KAD-1229 for up to 52 weeks (open-label period) with insulin throughout the study. KAD-1229 Insulin
Change From Baseline in HbA1c	0.05 % (value of HbA1c) Standard Deviation 1.04	-0.61 % (value of HbA1c) Standard Deviation 0.87

Adverse Events

Placebo/KAD-1229 (Data Through Week 16)

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

KAD-1229/KAD-1229 (Data Through Week 16)

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

KAD-1229 (Data Through Week 52)

Serious events: 18 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Development Division

Kissei Pharmaceutical Co., Ltd

Phone: Email only

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo/KAD-1229 (Data Through Week 16) n=60 participants at risk Show the adverse events which occurred with placebo administration during the double-blind period	KAD-1229/KAD-1229 (Data Through Week 16) n=118 participants at risk Show the adverse events which occurred with KAD-1229 administration during the double-blind period	KAD-1229 (Data Through Week 52) n=175 participants at risk KDT-1229 administration period in all patients
Infections and infestations Pneumonia	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.85% 1/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.85% 1/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.85% 1/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Nervous system disorders Thrombotic cerebral infarction	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Eye disorders Cataract	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Cardiac disorders Angina pectoris	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.85% 1/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	1.7% 3/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Cardiac disorders Angina unstable	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.85% 1/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Cardiac disorders Atrioventricular block complete	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Cardiac disorders Cardiac failure	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Cardiac disorders Myocardial ischaemia	1.7% 1/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Gastrointestinal disorders Large intestine polyp	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.57% 1/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Infections and infestations Pneumonia bacterial	1.7% 1/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Cardiac disorders Sick sinus syndrome	1.7% 1/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks

Measure	Placebo/KAD-1229 (Data Through Week 16) n=60 participants at risk Show the adverse events which occurred with placebo administration during the double-blind period	KAD-1229/KAD-1229 (Data Through Week 16) n=118 participants at risk Show the adverse events which occurred with KAD-1229 administration during the double-blind period	KAD-1229 (Data Through Week 52) n=175 participants at risk KDT-1229 administration period in all patients
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	1.7% 2/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	5.1% 9/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
General disorders Hunger	1.7% 1/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	1.7% 2/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	5.1% 9/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
General disorders Asthenia	3.3% 2/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	1.7% 2/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	4.6% 8/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Nervous system disorders Dizziness	1.7% 1/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	2.5% 3/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	4.6% 8/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Metabolism and nutrition disorders Hypoglycaemia	3.3% 2/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.85% 1/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Cardiac disorders Palpitations	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	1.7% 2/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Infections and infestations Nasopharyngitis	16.7% 10/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	11.0% 13/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	28.0% 49/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Infections and infestations Bronchitis	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Nervous system disorders Headache	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	1.7% 2/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Gastrointestinal disorders Constipation	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	1.7% 2/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Gastrointestinal disorders Diarrhoea	1.7% 1/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Musculoskeletal and connective tissue disorders Back pain	5.0% 3/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	2.5% 3/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.85% 1/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Investigations Blood triglycerides increased	1.7% 1/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	1.7% 2/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	4.6% 8/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Injury, poisoning and procedural complications Contusion	0.00% 0/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.85% 1/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 6/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Nervous system disorders Tremor	1.7% 1/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	3.4% 4/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	2.9% 5/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Infections and infestations Periodontitis	3.3% 2/60 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/118 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks	0.00% 0/175 • Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks