Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01413204
• Collaborator: (none)
• Enrollment: 272
• Locations: 5
• Arms: 3
• Duration (Months): 13
• Patients Per Site: 54.4
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: TA-7284 Low; Drug: TA-7284 High; Drug: Placebo	Phase 3

Detailed Description

This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TA-7284 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TA-7284 Low	Drug: TA-7284 Low; The patients will receive TA-7284-Low orally for 24 weeks.
Experimental: TA-7284 High	Drug: TA-7284 High; The patients will receive TA-7284-High orally for 24 weeks.
Placebo Comparator: Placebo	Drug: Placebo; The patients will receive Placebo orally for 24 weeks.

Outcome Measures

Primary Outcome Measures

1. Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) [baseline and 24 weeks]

Secondary Outcome Measures

1. Change in Fasting Plasma Glucose [Week 24]

2. Change in Body Weight [Week 24]

3. Change in Blood Pressure [Week 24]

4. Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test [Week 24]

5. Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs [Week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men or women age ≥20 years old

• Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period

• HbA1c of ≥7.0% and ≤10.0%

Exclusion Criteria:

• Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus

• Past or current history of severe diabetic complications

• Fasting plasma glucose > 270 mg/dL before treatment start

• History of hereditary glucose-galactose malabsorption or primary renal glucosuria

• Patients requiring insulin therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reserch site	Chubu		Japan
2	Reserch site	Kanto		Japan
3	Reserch site	Kinki		Japan
4	Reserch site	Shikoku		Japan
5	Reserch site	Tohoku		Japan

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: Nobuya Inagaki, M.D., Kyoto University, Graduate School of Medicine
• Study Director: Kazuoki Kondo, M.D., Mitsubishi Tanabe Pharma Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT01413204
• Other Study ID Numbers: TA-7284-05
• First Posted: Aug 10, 2011
• Last Update Posted: Jun 5, 2014
• Last Verified: May 1, 2014

• Keywords provided by Mitsubishi Tanabe Pharma Corporation: TA-7284; JNJ-28431754; Canagliflozin; Sodium Glucose Co-transporter (SGLT2 inhibitor)
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	TA-7284 Low	TA-7284 High	Placebo
Arm/Group Description	TA-7284 low dose, once daily for 24 weeks	TA-7284 high dose, once daily for 24 weeks	TA-7284 Placebo, once daily for 24 weeks
Period Title: Overall Study
STARTED	90	89	93
COMPLETED	84	83	74
NOT COMPLETED	6	6	19

Baseline Characteristics

Arm/Group Title	TA-7284 Low	TA-7284 High	Placebo	Total
Arm/Group Description	TA-7284 low dose, once daily for 24 weeks	TA-7284 high dose, once daily for 24 weeks	TA-7284 Placebo, once daily for 24 weeks	Total of all reporting groups
Overall Participants	90	89	93	272
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.4 (10.4)	57.3 (11.1)	58.2 (11)	58 (10.8)
Sex: Female, Male (Count of Participants)
Female	31 34.4%	16 18%	33 35.5%	80 29.4%
Male	59 65.6%	73 82%	60 64.5%	192 70.6%

Outcome Measures

1. Primary Outcome

Title	Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set, last observation carried forward

Arm/Group Title	TA-7284 Low	TA-7284 High	Placebo
Arm/Group Description	TA-7284 low dose, once daily for 24 weeks	TA-7284 high dose, once daily for 24 weeks	TA-7284 Placebo, once daily for 24 weeks
Measure Participants	90	88	93
Least Squares Mean (Standard Error) [percent HbA1C]	-0.74 (0.07)	-0.76 (0.07)	0.29 (0.07)

2. Secondary Outcome

Title	Change in Fasting Plasma Glucose
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Change in Body Weight
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Change in Blood Pressure
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	26 weeks
Arm/Group Title	TA-7284 Low		TA-7284 High		Placebo
Arm/Group Description	TA-7284 low dose, once daily for 24 weeks		TA-7284 high dose, once daily for 24 weeks		TA-7284 Placebo, once daily for 24 weeks
All Cause Mortality
	TA-7284 Low		TA-7284 High		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	TA-7284 Low		TA-7284 High		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/90 (1.1%)		1/89 (1.1%)		2/93 (2.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Gastric cancer	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Hepatic neoplasm malignant	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Oropharyngeal cancer stage unspecified	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Prostate cancer	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Other (Not Including Serious) Adverse Events
	TA-7284 Low		TA-7284 High		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/90 (65.6%)		55/89 (61.8%)		54/93 (58.1%)
Blood and lymphatic system disorders
Polycythaemia	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Cardiac disorders
Palpitations	1/90 (1.1%)		0/89 (0%)		1/93 (1.1%)
Ear and labyrinth disorders
Vertigo	0/90 (0%)		2/89 (2.2%)		0/93 (0%)
Eye disorders
Conjunctivitis allergic	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Diplopia	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Dry eye	1/90 (1.1%)		1/89 (1.1%)		0/93 (0%)
Punctate keratitis	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Gastrointestinal disorders
Abdominal discomfort	3/90 (3.3%)		0/89 (0%)		0/93 (0%)
Abdominal distension	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Abdominal pain upper	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Colonic polyp	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Constipation	1/90 (1.1%)		4/89 (4.5%)		1/93 (1.1%)
Dental caries	2/90 (2.2%)		1/89 (1.1%)		0/93 (0%)
Diarrhoea	1/90 (1.1%)		1/89 (1.1%)		0/93 (0%)
Dry mouth	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Enterocolitis	2/90 (2.2%)		0/89 (0%)		0/93 (0%)
Gastric ulcer	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Gastritis	2/90 (2.2%)		1/89 (1.1%)		3/93 (3.2%)
Gastritis atrophic	1/90 (1.1%)		1/89 (1.1%)		1/93 (1.1%)
Gastrooesophageal reflux disease	1/90 (1.1%)		1/89 (1.1%)		1/93 (1.1%)
Gingivitis	2/90 (2.2%)		1/89 (1.1%)		0/93 (0%)
Haemorrhoids	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Nausea	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Pancreatitis acute	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Periodontal disease	0/90 (0%)		1/89 (1.1%)		1/93 (1.1%)
Periodontitis	3/90 (3.3%)		3/89 (3.4%)		1/93 (1.1%)
Stomatitis	0/90 (0%)		1/89 (1.1%)		1/93 (1.1%)
Toothache	0/90 (0%)		1/89 (1.1%)		1/93 (1.1%)
General disorders
Asthenia	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Chest discomfort	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Hangover	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Hunger	1/90 (1.1%)		1/89 (1.1%)		0/93 (0%)
Thirst	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Hepatobiliary disorders
Hepatic function abnormal	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Infections and infestations
Acute tonsillitis	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Bacteriuria	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Bronchitis	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Chronic sinusitis	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Cystitis	0/90 (0%)		1/89 (1.1%)		1/93 (1.1%)
Enteritis infectious	0/90 (0%)		1/89 (1.1%)		1/93 (1.1%)
Folliculitis	1/90 (1.1%)		1/89 (1.1%)		0/93 (0%)
Gastroenteritis viral	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Herpes virus infection	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Herpes zoster	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Hordeolum	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Influenza	3/90 (3.3%)		0/89 (0%)		2/93 (2.2%)
Nasopharyngitis	19/90 (21.1%)		16/89 (18%)		27/93 (29%)
Oral herpes	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Pharyngitis	6/90 (6.7%)		1/89 (1.1%)		1/93 (1.1%)
Pharyngitis bacterial	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Pulpitis dental	0/90 (0%)		2/89 (2.2%)		1/93 (1.1%)
Pyelonephritis	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Tinea pedis	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Vulvitis	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Vulvovaginal candidiasis	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Vulvovaginal mycotic infection	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Injury, poisoning and procedural complications
Contusion	2/90 (2.2%)		4/89 (4.5%)		2/93 (2.2%)
Excoriation	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Face injury	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Forearm fracture	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Injury corneal	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Ligament sprain	2/90 (2.2%)		0/89 (0%)		0/93 (0%)
Mouth injury	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Skeletal injury	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Spinal compression fracture	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Thermal burn	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Investigations
Blood creatine phosphokinase increased	0/90 (0%)		0/89 (0%)		2/93 (2.2%)
Blood creatinine increased	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Blood ketone body increased	3/90 (3.3%)		7/89 (7.9%)		2/93 (2.2%)
Blood parathyroid hormone increased	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Blood pressure increased	0/90 (0%)		2/89 (2.2%)		4/93 (4.3%)
Blood triglycerides increased	0/90 (0%)		0/89 (0%)		2/93 (2.2%)
Blood uric acid increased	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Blood urine present	3/90 (3.3%)		1/89 (1.1%)		0/93 (0%)
Gamma-glutamyltransferase increased	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Urine albumin/creatinine ratio increased	0/90 (0%)		1/89 (1.1%)		1/93 (1.1%)
Urine ketone body present	1/90 (1.1%)		3/89 (3.4%)		0/93 (0%)
Urine output increased	1/90 (1.1%)		1/89 (1.1%)		0/93 (0%)
Weight decreased	2/90 (2.2%)		0/89 (0%)		0/93 (0%)
Metabolism and nutrition disorders
Gout	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Hypoglycaemia	2/90 (2.2%)		1/89 (1.1%)		2/93 (2.2%)
Hypoglycaemia unawareness	4/90 (4.4%)		5/89 (5.6%)		2/93 (2.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/90 (0%)		0/89 (0%)		2/93 (2.2%)
Back pain	2/90 (2.2%)		2/89 (2.2%)		1/93 (1.1%)
Bursitis	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Fasciitis	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Flank pain	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Lumbar spinal stenosis	1/90 (1.1%)		1/89 (1.1%)		1/93 (1.1%)
Muscle spasms	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Musculoskeletal pain	2/90 (2.2%)		0/89 (0%)		1/93 (1.1%)
Myofascial pain syndrome	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Neck pain	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Pain in extremity	0/90 (0%)		1/89 (1.1%)		2/93 (2.2%)
Periarthritis	1/90 (1.1%)		2/89 (2.2%)		1/93 (1.1%)
Spinal osteoarthritis	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Tenosynovitis	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Trigger finger	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Nervous system disorders
Cervicobrachial syndrome	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Dizziness	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Dizziness postural	1/90 (1.1%)		0/89 (0%)		1/93 (1.1%)
Headache	1/90 (1.1%)		1/89 (1.1%)		0/93 (0%)
Hypoaesthesia	1/90 (1.1%)		0/89 (0%)		2/93 (2.2%)
Migraine	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Post herpetic neuralgia	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Sciatica	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Renal and urinary disorders
Nephropathy	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Pollakiuria	4/90 (4.4%)		1/89 (1.1%)		1/93 (1.1%)
Urinary retention	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Reproductive system and breast disorders
Balanoposthitis	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Benign prostatic hyperplasia	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Cervical dysplasia	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Pulmonary fibrosis	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Rhinitis allergic	0/90 (0%)		1/89 (1.1%)		2/93 (2.2%)
Upper respiratory tract inflammation	3/90 (3.3%)		2/89 (2.2%)		1/93 (1.1%)
Skin and subcutaneous tissue disorders
Asteatosis	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Blister	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Dermatitis	1/90 (1.1%)		0/89 (0%)		1/93 (1.1%)
Dermatitis allergic	0/90 (0%)		0/89 (0%)		2/93 (2.2%)
Dermatitis contact	2/90 (2.2%)		0/89 (0%)		1/93 (1.1%)
Eczema	1/90 (1.1%)		3/89 (3.4%)		1/93 (1.1%)
Eczema asteatotic	0/90 (0%)		1/89 (1.1%)		2/93 (2.2%)
Heat rash	0/90 (0%)		0/89 (0%)		1/93 (1.1%)
Rash	0/90 (0%)		1/89 (1.1%)		1/93 (1.1%)
Seborrhoeic dermatitis	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Skin fissures	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Toxic skin eruption	0/90 (0%)		1/89 (1.1%)		0/93 (0%)
Vascular disorders
Hot flush	1/90 (1.1%)		0/89 (0%)		0/93 (0%)
Hypertension	0/90 (0%)		0/89 (0%)		3/93 (3.2%)
Orthostatic hypotension	0/90 (0%)		1/89 (1.1%)		0/93 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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