UMIN-CTR Clinical Trial

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
Email	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
Email	dpvdtrial@mbox.med.uoeh-u.ac.jp

Sponsor
Institute	Shin Komonji Hospital Department of Endocrinology and Diabetes
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055192