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

• Sponsor: Kissei Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02154347
• Collaborator: (none)
• Enrollment: 178
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: KAD-1229; Drug: Placebo; Drug: Insulin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 178 participants
• Actual Primary Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: KAD-1229; Drug: Insulin
Other: 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.	Drug: KAD-1229; Drug: Placebo; Drug: Insulin

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in HbA1c [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start

• Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0%

Exclusion Criteria:

• Type 1 Diabetes Mellitus

• Patients with serious diabetic complications and other serious complications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Multiple Locations		Japan

Sponsors and Collaborators

• Kissei Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kissei Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02154347
• Other Study ID Numbers: KAD6401
• First Posted: Jun 3, 2014
• Last Update Posted: Sep 6, 2019
• Last Verified: May 1, 2017

• Keywords provided by Kissei Pharmaceutical Co., Ltd.: Type 2 Diabetes Mellitus; HbA1c
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Mitiglinide

Study Results

Participant Flow

Arm/Group Title	Placebo/KAD-1229	KAD-1229/KAD-1229
Arm/Group Description	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	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
Period Title: Double-blind Period
STARTED	60	118
COMPLETED	57	114
NOT COMPLETED	3	4
Period Title: Double-blind Period
STARTED	57	113
COMPLETED	50	88
NOT COMPLETED	7	25

Baseline Characteristics

Arm/Group Title	Placebo/KAD-1229	KAD-1229/KAD-1229	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	60	118	178
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.5 (11.7)	59.7 (10.3)	58.6 (10.9)
Sex: Female, Male (Count of Participants)
Female	9 15%	39 33.1%	48 27%
Male	51 85%	79 66.9%	130 73%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	60 100%	118 100%	178 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
HbA1c (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	8.54 (0.85)	8.48 (0.70)	8.50 (0.75)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in HbA1c
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

full analysis set

Arm/Group Title	Placebo/KAD-1229	KAD-1229/KAD-1229
Arm/Group Description	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	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
Measure Participants	60	118
Mean (Standard Deviation) [% (value of HbA1c)]	0.05 (1.04)	-0.61 (0.87)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo/KAD-1229, KAD-1229/KAD-1229
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.66
	Confidence Interval	(2-Sided) 95%; -0.95 to -0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Placebo/KAD-1229 and KAD-1229/KAD-1229: 16 weeks, KAD-1229: 52 weeks
Arm/Group Title	Placebo/KAD-1229 (Data Through Week 16)		KAD-1229/KAD-1229 (Data Through Week 16)		KAD-1229 (Data Through Week 52)
Arm/Group Description	Show the adverse events which occurred with placebo administration during the double-blind period		Show the adverse events which occurred with KAD-1229 administration during the double-blind period		KDT-1229 administration period in all patients
All Cause Mortality
	Placebo/KAD-1229 (Data Through Week 16)		KAD-1229/KAD-1229 (Data Through Week 16)		KAD-1229 (Data Through Week 52)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/118 (0%)		0/175 (0%)
Serious Adverse Events
	Placebo/KAD-1229 (Data Through Week 16)		KAD-1229/KAD-1229 (Data Through Week 16)		KAD-1229 (Data Through Week 52)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/60 (3.3%)		4/118 (3.4%)		18/175 (10.3%)
Cardiac disorders
Angina pectoris	0/60 (0%)		1/118 (0.8%)		3/175 (1.7%)
Angina unstable	0/60 (0%)		1/118 (0.8%)		1/175 (0.6%)
Arteriosclerosis coronary artery	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Atrioventricular block complete	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Cardiac failure	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Myocardial ischaemia	1/60 (1.7%)		0/118 (0%)		1/175 (0.6%)
Sick sinus syndrome	1/60 (1.7%)		0/118 (0%)		0/175 (0%)
Eye disorders
Cataract	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Gastrointestinal disorders
Large intestine polyp	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Infections and infestations
Pneumonia	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Pneumonia bacterial	1/60 (1.7%)		0/118 (0%)		0/175 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/60 (0%)		1/118 (0.8%)		1/175 (0.6%)
Metastases to liver	0/60 (0%)		1/118 (0.8%)		1/175 (0.6%)
Pancreatic carcinoma	0/60 (0%)		1/118 (0.8%)		1/175 (0.6%)
Renal cancer	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Prostate cancer	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Nervous system disorders
Thrombotic cerebral infarction	0/60 (0%)		0/118 (0%)		1/175 (0.6%)
Other (Not Including Serious) Adverse Events
	Placebo/KAD-1229 (Data Through Week 16)		KAD-1229/KAD-1229 (Data Through Week 16)		KAD-1229 (Data Through Week 52)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/60 (31.7%)		28/118 (23.7%)		98/175 (56%)
Cardiac disorders
Palpitations	0/60 (0%)		2/118 (1.7%)		6/175 (3.4%)
Gastrointestinal disorders
Constipation	0/60 (0%)		2/118 (1.7%)		6/175 (3.4%)
Diarrhoea	1/60 (1.7%)		0/118 (0%)		6/175 (3.4%)
General disorders
Hunger	1/60 (1.7%)		2/118 (1.7%)		9/175 (5.1%)
Asthenia	2/60 (3.3%)		2/118 (1.7%)		8/175 (4.6%)
Infections and infestations
Nasopharyngitis	10/60 (16.7%)		13/118 (11%)		49/175 (28%)
Bronchitis	0/60 (0%)		0/118 (0%)		6/175 (3.4%)
Periodontitis	2/60 (3.3%)		0/118 (0%)		0/175 (0%)
Injury, poisoning and procedural complications
Contusion	0/60 (0%)		1/118 (0.8%)		6/175 (3.4%)
Investigations
Blood triglycerides increased	1/60 (1.7%)		2/118 (1.7%)		8/175 (4.6%)
Metabolism and nutrition disorders
Hypoglycaemia	2/60 (3.3%)		1/118 (0.8%)		6/175 (3.4%)
Musculoskeletal and connective tissue disorders
Back pain	3/60 (5%)		3/118 (2.5%)		6/175 (3.4%)
Periarthritis	0/60 (0%)		1/118 (0.8%)		6/175 (3.4%)
Nervous system disorders
Dizziness	1/60 (1.7%)		3/118 (2.5%)		8/175 (4.6%)
Headache	0/60 (0%)		2/118 (1.7%)		6/175 (3.4%)
Tremor	1/60 (1.7%)		4/118 (3.4%)		5/175 (2.9%)
Skin and subcutaneous tissue disorders
Cold sweat	0/60 (0%)		2/118 (1.7%)		9/175 (5.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.