UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003989 |
|---|---|
| Receipt number | R000004713 |
| Scientific Title | Effects of sitagliptin addition versus sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea: a randomized, multicenter, open-label trial |
| Date of disclosure of the study information | 2010/11/11 |
| Last modified on | 2022/03/24 12:09:24 |
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Basic information
Public title
Effects of sitagliptin addition versus sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea: a randomized, multicenter, open-label trial
Acronym
Saitama Sitagliptin Study (3S)
Scientific Title
Effects of sitagliptin addition versus sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea: a randomized, multicenter, open-label trial
Scientific Title:Acronym
Saitama Sitagliptin Study (3S)
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare effects of sitagliptin addition with sulfonylurea intensification on beta cell function in patients with type 2 diabetes inadequately controlled on sulfonylurea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Serum C peptide concentration
Intact proinsulin/insulin ratio
Key secondary outcomes
HbA1c, fasting plasma glucose, HOMA-beta LDL cholesterol, HDL chplesterol, triglyceride, urinary albumin, cystatin C, high sensitivity C-reactive protein, high molecular weight adiponectin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Glimepiride at a dose of 1 mg plus sitagliptin group
Interventions/Control_2
Glimepiride intesification group
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inadequately controlled type 2 diabetic patients who are taking sulfonylurea (glymepiride at a dose of 1 mg to 2 mg)for more than 1 month.
Patients whose HbA1c ranges from 7.0% to 9.0% (JDS value).
Key exclusion criteria
1. Patients who had diabetic ketoacidosis, or diabetic pre- and coma within 6 months of the study entry.
2. Patients who received surgery operation during the study.
3. Patients with pregnancy or Nursing mothers
4. Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl)
5. Patients who received insulin therapy
6. Patients who had a history of hypersensitivity reaction to sitagliptin
7. Patients whom the attending doctor estimated to be ineligible according to the medical rationale.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Shigehiro |
| Middle name | |
| Last name | Katayama |
Organization
Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
350-0495
Address
38 Morohongo, Moroyama, Iruma-gun, Saitama 350-0495,Japan
TEL
049-276-1204
skataya@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Aso |
Organization
Dokkyo Medical University
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 Kita-Kobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
yaso@dokkyomed.ac.jp
Sponsor or person
Institute
Saitama Sitagliptin Study (3S)
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan Inc
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sitama Medical University IRB
Address
38 Morohongo, Moroyama, Iruma-gun, Saitama 350-0495,Japan
Tel
049-276-1111
skataya@saitama-med.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
埼玉医科大学病院（埼玉県）、埼玉医科大学総合医療センター（埼玉県）、
防衛医科大学校病院（埼玉県）、自治医科大学附属さいたま医療センター（埼玉県）
獨協医科大学越谷病院（埼玉県）、西埼玉中央病院（埼玉県）
埼玉社会保険病院（埼玉県）、さいたま赤十字病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
https://doi.org/10.14740/jem621
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.14740/jem621
Number of participants that the trial has enrolled
60
Results
After 18 months, HbA1c had significantly decreased to 7.1-7.2% in both groups (P < 0.01). Plasma levels of insulin and proinsulin remained unchanged during the study. However, the proinsulin/insulin ratio was significantly lower after 6 months and thereafter only in the SU group. Homeostasis model assessment-be-ta cell (HOMA-be-ta) demonstrated a significant augmentation at some points during the study in both groups. No severe hypoglycemic episodes or body weight gain were seen in either group.
Results date posted
| 2022 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 12 | Month | 01 | Day |
Baseline Characteristics
Japanese patients with type 2 diabetes mellitus
Participant flow
a daily administration of 50 mg sitagliptin added to a very small dose of glimepiride, SUs, of 1.1 mg (SIT group), versus a small dose of glimepiride added by 1 mg to its basal dosage, i.e., 2.1 mg (SU group)
Adverse events
Throughout the study, body weight did not show any increases in either group (Table 2). No severe hypoglycemic episodes were seen in either group except one each in the SIT and
SU group who discontinued the study as mentioned above.
Outcome measures
glycemic control and be-ta-cell function
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2010 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 08 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 03 | Day |
Last modified on
| 2022 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004713
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| Registered date | File name |
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