UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048432 |
|---|---|
| Receipt number | R000055192 |
| Scientific Title | The effect of active vitamin D on reducing the development of type 2 diabetes from prediabetes (Phase IV, multicenter, randomized, double-blind, placebo controlled, and parallel group comparison) |
| Date of disclosure of the study information | 2022/07/22 |
| Last modified on | 2022/07/22 11:00:40 |
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Basic information
Public title
The effect of active vitamin D on reducing the development of type 2 diabetes from prediabetes (Phase IV, multicenter, randomized, double-blind, placebo controlled, and parallel group comparison)
Acronym
DPVD plus (Diabetes Prevention with active Vitamin D-for Patients with Low insUlin Secretion) trial (Phase IV, multicenter, randomized, double-blind, placebo controlled, and parallel group comparison)
Scientific Title
The effect of active vitamin D on reducing the development of type 2 diabetes from prediabetes (Phase IV, multicenter, randomized, double-blind, placebo controlled, and parallel group comparison)
Scientific Title:Acronym
DPVD plus (Diabetes Prevention with active Vitamin D-for Patients with Low insUlin Secretion) trial (Phase IV, multicenter, randomized, double-blind, placebo controlled, and parallel group comparison)
Region
| Japan |
Condition
Condition
prediabetes (impaired fasting glucose and/or impaired glucose tolerance)
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this trial is to evaluate the effect of active vitamin D to reduce the progression from prediabetes to type 2 diabetes, as compared with placebo.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The development of type 2 diabetes from prediabetes between the two groups after 3-year treatment.
Key secondary outcomes
1. The improvement ratio from prediabetes to normoglycemia.
2. The incidence of type 2 diabetes after adjusting for treatment group (eldecalcitol or placebo) and confounding factors at baseline: age, sex (male/female), presence or absence of hypertension (systolic 140 or more mmHg and/or diastolic 90 or more mmHg), body mass index, family history of diabetes (yes / no), HbA1c, fasting plasma glucose, 2-hour plasma glucose, 25-hydroxy vitamin D, and 1,25-dihydroxy vitamin D.
3. The incidence of type 2 diabetes in each subgroup at baseline variables: age (more or less 65 years), sex (male/female), obesity (BMI more or less 25 kg/m2), presence or absence of hypertension (systolic more 140 mmHg and/or diastolic more 90 mmHg), family history of diabetes (yes / no), fasting plasma glucose (more or less 110 mg/dl), 2-hour plasma glucose (more or less 170 mg/dl), 25-hydroxy vitamin D (more or less 20 ng/ml), and 1,25-dihydroxy vitamin D (more or less 20 pg/ml).
4. The incidence of adverse events between the two groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Participants take 0.75 mcg of eldecalcitol capsule once daily for at least 3 years. However, the study will be ended when a patient is diagnosed with type 2 diabetes. First interim analysis will be performed after one year of enrollment of all 903 participants. A second interim analysis will be performed when 60% (97 patients) of the 161 patients, who are expected to develop diabetes during the 3-year period, develop type 2 diabetes.
Interventions/Control_2
Participants take placebo capsule once daily for at least 3 years. However, the study will be ended when a patient is diagnosed with type 2 diabetes. First interim analysis will be performed after one year of enrollment of all 903 participants. A second interim analysis will be performed when 60% (97 patients) of the 161 patients, who are expected to develop diabetes during the 3-year period, develop type 2 diabetes.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. fasting plasma glucose level of <=125mg/dL and 2-hour plasma glucose level of 140 to 199mg/dl in a 75g oral glucose tolerance test (impaired glucose tolerance, IGT).
OR fasting plasma glucose level of 100 to 125mg/dL and 2-hour plasma glucose level of <=199mg/dl in a 75g oral glucose tolerance test (impaired fasting glucose, IFG).
2. HbA1c < 6.5%
3. fasting IRI <=5.6mcU/mL and HOMA-beta <=44.0%.
Key exclusion criteria
Participants are ineligible if they meet any of the following criteria: have a history of diabetes; participate in other clinical trials; have a history of taking anti-diabetes drugs, other active vitamin D, and/or bisphosphonates within the past three months; are pregnant; have coronary, peripheral, or cerebrovascular disease; or have some types of severe diseases (e.g., mental disorder, collagen disease, renal insufficiency, hepatic insufficiency, or terminal disease).
Target sample size
904
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
University of Occupational and Environmental Health
Division name
First Department of Internal Medicine
Zip code
807-8556
Address
1-1 Iseigaoka, Yahatanishi, Kitakyushu
TEL
093-603-1611
k-tetsuy@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kawahara |
Organization
Shin Komonji Hospital
Division name
Endocrinology and Diabetes
Zip code
800-0057
Address
2-5 Dairishinmachi, Moji, Kitakyushu
TEL
093-391-1001
Homepage URL
dpvdtrial@mbox.med.uoeh-u.ac.jp
Sponsor or person
Institute
Shin Komonji Hospital
Department of Endocrinology and Diabetes
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shin Komonji Hospital
Address
2-5 Dairishinmachi, Moji, Kitakyushu
Tel
093-391-1001
dpvdtrial@mbox.med.uoeh-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 22 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055192
