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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010598
Receipt No. R000010180
Scientific Title Long term effect of Japanese Kampo formula gosyajinkigan in diabetic complication; randomized open-labeled trial.
Date of disclosure of the study information 2013/05/01
Last modified on 2013/04/26

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Basic information
Public title Long term effect of Japanese Kampo formula gosyajinkigan in diabetic
complication; randomized open-labeled trial.
Acronym Long term effect of Japanese Kampo formula gosyajinkigan in diabetic
complication; randomized open-labeled trial.
Scientific Title Long term effect of Japanese Kampo formula gosyajinkigan in diabetic
complication; randomized open-labeled trial.
Scientific Title:Acronym Long term effect of Japanese Kampo formula gosyajinkigan in diabetic
complication; randomized open-labeled trial.
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism Geriatrics
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether a Kampo formula
goshajinkigan (TJ107) would reduce the rate of cardiovascular events, microvascular complications and any laboratory abnormalities as compared with control group without this kampo formulation in middle-aged and older people with diabetes mellitus.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The prespecified primary endpoints were the first occurrence of nonfatal myocardial infarction or nonfatal stroke or one or more upstaging of diabetic nephropathy(DN) or retinopathy(DR).
Key secondary outcomes body weight, blood
pressure, fasting blood glucose, glycated hemoglobin, serum insulin (c-peptide reactivity on insulin user) , total cholesterol, triglycelide, high density lipoprotein, serum creatinin, urea
nitrogen and diabetic neuropathy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Regular treatment plus Kampo formulation goshajinkigan
(TJ107) every 3 preprandial for 5 years
Interventions/Control_2 Regular treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria volunteers who had type 2 diabetes mellitus and a glycated hemoglobin level
of 6.5% or more and who either were between the ages of 40 and 75 years without neither macroalbuminuria nor serum creatinin level of more than 1.3 mg per deciliter nor diabetic retinopathy over pre-proliferative retinopathy.
Key exclusion criteria past macrovascular event including stroke, myocardial infarction, angina pectoris, foot gangrene, atheroscrerotic obstruction and other serious complication, taking other kampo formulation, drug allergy to TJ107, pregnant or lactating women and unwillingness to enter the study.
Additional exclusion criteria were a body mass index of &#8805;30 kg/m2; 2 or more digestive system symptoms (e.g., gastrointestinal weakness, anorexia, nausea, and diarrhea); and 3 or more symptoms or activities indicative of sensitivity to heat, including a preference for dressing lightly, sweating upwards from the neck, a liking for cold water, a flushed face, congestion of the eyeballs, and a tendency towards high body temperatures (not less than 36.7 degrees cercius).
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Watanabe
Organization School of medicine, Keio University
Division name centor for Kampo medicine
Zip code
Address Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-5366-3824
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Watanabe
Organization School of medicine, Keio University
Division name centor for Kampo medicine
Zip code
Address Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-5366-3824
Homepage URL
Email watanabekenji@a6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization the Ministry of Health, Labor and Welfare Research Council of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Tsumura Co.(Tokyo, Japan) manufactures of TJ107

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Patients

A total of 117 men and women with a median age of 61 years (range, 41 to 76 years) and a median glycated hemoglobin level of 7.5% (range, 6.5 to 12.2%) were randomly assigned to either the TJ107 group or the control group. Approximately 40% of both patient cohorts were women. The key baseline characteristics were similar in the 2 study groups. The mean duration of follow-up was 28 months for the TJ107 group and 15 months for the control group. The trial was stopped when the national funding stopped, although significantly more volunteers were to be included in the trial. 

Use of Glucose-Lowering Therapy and Other Treatments

During the follow-up period, the use of most classes of oral hypoglycemic drugs and of insulin was the same in the 2 groups. In addition, the use of blood pressure-lowering, lipid-modifying, and antiplatelet treatments was similar between the 2 groups during the follow-up period. However, the combined use of several drugs occurred at a much lower frequency than our general experience, so that patients may not have accurately reported medication use in all cases.

Effects on Primary Outcomes

A total of 43 participants had a microvascular event: 40.2% in the TJ107 group and 39.1% in the control group (P = 0.752, Figure 3). No macrovascular event occurred in either group.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2000 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2000 Year 03 Month 01 Day
Last follow-up date
2007 Year 08 Month 31 Day
Date of closure to data entry
2007 Year 08 Month 31 Day
Date trial data considered complete
2007 Year 08 Month 31 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information Effects on Secondary Outcomes

Stable median levels of glycated hemoglobin of 7.8% (interquartile range, 6.4 to 11.5) and 7.9% (interquartile range, 6.7 to 13.5), were maintained in the TJ107 and control groups, respectively, throughout the follow-up period. According to an exploratory examination, the glycated hemoglobin of the TJ107 group decreased significantly in the 60th month as compared to the control group, but not at the final point. Fasting plasma glucose also decreased significantly beginning at the 36th month relative to baseline, while no significant changes were observed in the control group. No significant differences were observed in terms of insulin doses or oral anti-diabetic medications.

The progression of the grade of the ankle reflex was significantly more frequent in the control group. Other outcomes, including body mass index and laboratory test results, showed no significant differences.

Most patients had no subjective symptoms through the trial period. An analysis of only the patients who had a change in subjective symptoms was performed, in addition to an analysis of the entire set of patients. For the patients who experienced a change in symptoms, the occurrence of constipation and diarrhea was significantly improved in the TJ107 group. For the entire set of patients, no significant changes occurred for any of the issues addressed in the questions. There was no dropout due to the side effects of TJ107.

Management information
Registered date
2013 Year 04 Month 26 Day
Last modified on
2013 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010180

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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