Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00497198
• Collaborator: (none)
• Enrollment: 183
• Arms: 2
• Duration (Months): 23

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: MCI-196; Drug: Placebo of MCI-196 Tablet	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Exploratory Study of MCI-196 for Treatment of Type 2 Diabetes in Randomized, Double-Blind, Parallel-Assignment, Placebo-Controlled Manner
• Study Start Date: Oct 1, 2005
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MCI-196	Drug: MCI-196; Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg); Other Names: Colestilan(INN) Colestimide(JAN) CHOLEBINE
Placebo Comparator: Placebo	Drug: Placebo of MCI-196 Tablet; Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration

Outcome Measures

Primary Outcome Measures

1. Fasting Plasma Glucose at Baseline [0 weeks]

2. Change From Baseline in Blood Glucose at Week 12 [12 weeks (baseline to week 12)]

3. Hemoglobin A1c (HbA1c) at Baseline [0 weeks]

4. Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12 [12 weeks (baseline to week 12)]

Secondary Outcome Measures

1. Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12 [12 weeks (baseline to week 12)]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL.

• Patients whose HbA1c is 7.0% or above during the observation period.

Exclusion Criteria:

• Patients with serious cardiac, hepatic or renal complications.

• Patients with serious diabetic complications.

• Patients with complete biliary obstruction or ileus.

• Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

• Study Director: Kazuoki Kondo, MD, Mitsubishi Tanabe Pharma Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00497198
• Other Study ID Numbers: MCI196-19
• First Posted: Jul 6, 2007
• Last Update Posted: Jun 8, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by , ,: Type 2 Diabetes; anion-exchange resin
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Bile Acids and Salts

Study Results

Participant Flow

Arm/Group Title	MCI-196	Placebo
Arm/Group Description	Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)	Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Period Title: Overall Study
STARTED	92	91
COMPLETED	87	86
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	MCI-196	Placebo	Total
Arm/Group Description	Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)	Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration	Total of all reporting groups
Overall Participants	92	91	183
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	60 65.2%	55 60.4%	115 62.8%
>=65 years	32 34.8%	36 39.6%	68 37.2%
Sex: Female, Male (Count of Participants)
Female	33 35.9%	34 37.4%	67 36.6%
Male	59 64.1%	57 62.6%	116 63.4%

Outcome Measures

1. Secondary Outcome

Title	Change From Baseline in Low Density Lipoprotein Cholesterol(LDL-c) at Week 12
Time Frame	12 weeks (baseline to week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MCI-196	Placebo
Arm/Group Description	Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)	Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Measure Participants	86	86
Mean (Standard Error) [mg/dL]	-28.9 (2.0)	-0.2 (2.0)

2. Primary Outcome

Title	Fasting Plasma Glucose at Baseline
Time Frame	0 weeks

Outcome Measure Data

Analysis Population Description

Per protocol set

Arm/Group Title	MCI-196	Placebo
Arm/Group Description	Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)	Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Measure Participants	86	86
Mean (Standard Deviation) [mg/dL]	170.2 (21.1)	168.2 (20.5)

3. Primary Outcome

Title	Change From Baseline in Blood Glucose at Week 12
Time Frame	12 weeks (baseline to week 12)

Outcome Measure Data

Analysis Population Description

Per protocol set; Last observation carried forward

Arm/Group Title	MCI-196	Placebo
Arm/Group Description	Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)	Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Measure Participants	86	86
Mean (Standard Error) [mg/dL]	-21.3 (2.2)	0.8 (2.2)

4. Primary Outcome

Title	Hemoglobin A1c (HbA1c) at Baseline
Time Frame	0 weeks

Outcome Measure Data

Analysis Population Description

Per protocol set

Arm/Group Title	MCI-196	Placebo
Arm/Group Description	Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)	Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Measure Participants	86	86
Mean (Standard Deviation) [percentage]	7.97 (0.72)	7.94 (0.77)

5. Primary Outcome

Title	Change From Baseline in Hemoglobin A1c(HbA1c) at Week 12
Time Frame	12 weeks (baseline to week 12)

Outcome Measure Data

Analysis Population Description

Per protocol set; Last observation carried forward

Arm/Group Title	MCI-196	Placebo
Arm/Group Description	Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)	Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Measure Participants	86	86
Mean (Standard Error) [percentage]	-0.70 (0.06)	0.18 (0.06)

Adverse Events

Time Frame	1MCI-196: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg) Placebo: Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Arm/Group Title	MCI-196		Placebo
Arm/Group Description	Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)		Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
All Cause Mortality
	MCI-196		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MCI-196		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/92 (1.1%)		5/91 (5.5%)
Gastrointestinal disorders
Colon polyp	0/92 (0%)		1/91 (1.1%)
Musculoskeletal and connective tissue disorders
Back pain	0/92 (0%)		1/91 (1.1%)
Rotator cuff syndrome	0/92 (0%)		1/91 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/92 (0%)		1/91 (1.1%)
Nervous system disorders
Cerebral infarction	1/92 (1.1%)		0/91 (0%)
Vascular disorders
Peripheral embolism	0/92 (0%)		1/91 (1.1%)
Other (Not Including Serious) Adverse Events
	MCI-196		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	53/92 (57.6%)		46/91 (50.5%)
Ear and labyrinth disorders
Vertigo	0/92 (0%)		1/91 (1.1%)
Sudden hearing loss	0/92 (0%)		1/91 (1.1%)
Eye disorders
Cataract	0/92 (0%)		2/91 (2.2%)
Corneal erosion	0/92 (0%)		1/91 (1.1%)
Diabetic retinopathy	1/92 (1.1%)		0/91 (0%)
Episcleritis	1/92 (1.1%)		0/91 (0%)
Eye pain	1/92 (1.1%)		0/91 (0%)
Gastrointestinal disorders
Abdominal distension	1/92 (1.1%)		2/91 (2.2%)
Abdominal pain	1/92 (1.1%)		0/91 (0%)
Constipation	12/92 (13%)		4/91 (4.4%)
Diarrhoea	0/92 (0%)		4/91 (4.4%)
Faeces hard	3/92 (3.3%)		0/91 (0%)
Food poisoning	0/92 (0%)		1/91 (1.1%)
Gastric polyps	0/92 (0%)		1/91 (1.1%)
Gastritis	0/92 (0%)		1/91 (1.1%)
Gastritis atrophic	1/92 (1.1%)		0/91 (0%)
Gastritis erosive	0/92 (0%)		1/91 (1.1%)
Stomatitis	0/92 (0%)		2/91 (2.2%)
Toothache	0/92 (0%)		1/91 (1.1%)
General disorders
Pyrexia	0/92 (0%)		1/91 (1.1%)
Infections and infestations
Acute tonsillitis	0/92 (0%)		1/91 (1.1%)
Bronchitis	1/92 (1.1%)		0/91 (0%)
Cystitis	0/92 (0%)		1/91 (1.1%)
Folliculitis	0/92 (0%)		1/91 (1.1%)
Gastroenteritis	1/92 (1.1%)		1/91 (1.1%)
Gastroenteritis Escherichia coli	1/92 (1.1%)		0/91 (0%)
Herpes zoster	1/92 (1.1%)		1/91 (1.1%)
Influenza	1/92 (1.1%)		2/91 (2.2%)
Nasopharyngitis	18/92 (19.6%)		12/91 (13.2%)
Otitis media	0/92 (0%)		1/91 (1.1%)
Paronychia	1/92 (1.1%)		0/91 (0%)
Pharyngitis	2/92 (2.2%)		1/91 (1.1%)
Tinea pedis	0/92 (0%)		1/91 (1.1%)
Injury, poisoning and procedural complications
Foot fracture	0/92 (0%)		1/91 (1.1%)
Joint sprain	1/92 (1.1%)		0/91 (0%)
Radius fracture	0/92 (0%)		1/91 (1.1%)
Contusion	0/92 (0%)		1/91 (1.1%)
Musculoskeletal and connective tissue disorders
Back pain	2/92 (2.2%)		0/91 (0%)
Muscle spasms	2/92 (2.2%)		1/91 (1.1%)
Myalgia	1/92 (1.1%)		0/91 (0%)
Osteoarthritis	2/92 (2.2%)		0/91 (0%)
Pain in extremity	1/92 (1.1%)		1/91 (1.1%)
Trigger finger	1/92 (1.1%)		0/91 (0%)
Intervertebral disc protrusion	1/92 (1.1%)		0/91 (0%)
Intervertebral disc disorder	0/92 (0%)		1/91 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma	1/92 (1.1%)		0/91 (0%)
Oesophageal neoplasma	0/92 (0%)		1/91 (1.1%)
Nervous system disorders
Cervicobrachial syndrome	0/92 (0%)		1/91 (1.1%)
Diabetic neuropathy	0/92 (0%)		1/91 (1.1%)
Dizziness	1/92 (1.1%)		2/91 (2.2%)
Dysgeusia	0/92 (0%)		1/91 (1.1%)
Hypoaesthesia	1/92 (1.1%)		0/91 (0%)
Migraine	1/92 (1.1%)		0/91 (0%)
Sciatica	0/92 (0%)		1/91 (1.1%)
Tension headache	1/92 (1.1%)		0/91 (0%)
Intercostal neuralgia	0/92 (0%)		1/91 (1.1%)
Renal and urinary disorders
Haematuria	0/92 (0%)		1/91 (1.1%)
Respiratory, thoracic and mediastinal disorders
Cough	0/92 (0%)		3/91 (3.3%)
Rhinorrhoea	1/92 (1.1%)		0/91 (0%)
Upper respiratory tract inflammation	4/92 (4.3%)		3/91 (3.3%)
Skin and subcutaneous tissue disorders
Blister	0/92 (0%)		1/91 (1.1%)
Dermatitis bullous	0/92 (0%)		1/91 (1.1%)
Eczema	5/92 (5.4%)		0/91 (0%)
Heat rash	0/92 (0%)		1/91 (1.1%)
Ingrowing nail	1/92 (1.1%)		0/91 (0%)
Pruritus	1/92 (1.1%)		0/91 (0%)
Rash	2/92 (2.2%)		1/91 (1.1%)
Schamberg's disease	0/92 (0%)		1/91 (1.1%)
Vascular disorders
Arteriosclerosis obliterans	0/92 (0%)		1/91 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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