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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017637
Receipt No. R000020436
Scientific Title Effects of basal insulin therapy on postprandial glucose level
Date of disclosure of the study information 2015/06/01
Last modified on 2016/11/21

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Basic information
Public title Effects of basal insulin therapy on postprandial glucose level
Acronym Effects of basal insulin therapy on postprandial glucose level
Scientific Title Effects of basal insulin therapy on postprandial glucose level
Scientific Title:Acronym Effects of basal insulin therapy on postprandial glucose level
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We preliminary indicated that basal insulin therapy reduced postprandial gulucose increment. We examine effects of basal insulin therapy on postprandial glucose level and try to elucidate factors associated with improvement of it. In addition, we compare insulin glargine with insulin degludec in order to investigate the effects on nocturnal hypoglycemic risk and postprandial glucose improvement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes amount of increase in plasma glucose level
Key secondary outcomes CPR, proinsulin, adiponectin(HMW), high-sensitive TNF-alpha, IL-6, high-sensitive CRP, NEFA, BCAA

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Glargine
Interventions/Control_2 Degludec
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria T2DM inpatients whose FPG level is above 150mg/dL.
Key exclusion criteria untreated PPDR or PDR, nephropathy stage 4 or 5, acute glucose metabolic disturbance, cancer, acute illness, post-operation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuma Ogiso
Organization Kagoshima Medical Center
Division name Diabetes/Endocirne medicine
Zip code
Address 8-1 Shiroyama-cho Kagoshima city
TEL 099-223-1151
Email nomushi@kagomc2.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuma Ogiso
Organization shima Medical Center
Division name Diabetes/Endocirne medicine
Zip code
Address 8-1 Shiroyama-cho Kagoshima city
TEL 099-223-1151
Homepage URL
Email nomushi@kagomc2.hosp.go.jp

Sponsor
Institute Kagoshima Medical Center
Institute
Department

Funding Source
Organization None
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
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 鹿児島医療センター(鹿児島県)

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Primary endpoint (post-breakfast glucose levels)
High and low values for FPG were 8.8 +- 1.3 and 5.7 +- 0.4 mmol/L, respectively and the corresponding basal insulin doses were 7.2 +- 2.4 (0.10 +- 0.03) and 18.8 +- 7.6 U (0.28 +- 0.08 U/kg), respectively. Low FPG was achieved at 9.1 +- 2.6 days. 
Post-breakfast IAUCG-4h decreased by 47% in low, compared with high FPG (from 213.2 +- 73.7 to 114.9 +- 60.4 mmolh/L, p < 0.001; Figure 1), whereas post-lunch and -dinner glucose levels obtained by CGM did not (p = 0.29, p = 0.071; Figure 1). The decrease in post-breakfast IAUCG-4h between high FPG and low FPG (delta IAUCG-4h) did not significantly correlate with changes in FPG (r = 0.146, p = 0.57).
 A significant decrease in body weight among patients with low FPG from 65.5 +- 12.5 to 64.2 +- 11.9 kg (p = 0.007) did not significantly correlate with post-breakfast delta IAUCG-4h (r = 0.074, p = 0.77). Overall rates of hypoglycemia determined by CGM in low FPG were 1.1% +- 2.6% (degludec vs. glargine, 2.4% +- 3.6% vs. 0.1 +- 0.2%). 
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
2015 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2016 Year 10 Month 31 Day
Date of closure to data entry
2016 Year 11 Month 30 Day
Date trial data considered complete
2016 Year 11 Month 30 Day
Date analysis concluded
2016 Year 11 Month 30 Day

Other
Other related information Secondary endpoints (free fatty acids, C-peptide, proinsulin)
Fasting serum FFA levels decreased by 47% in low, compared with high FPG (from 457.3 +- 184.1 to 244.2 +- 98.0 uEq/L, p < 0.001; Figure 2a). Similarly, fasting and post-breakfast serum CPR levels significantly decreased from 1.3 +- 0.8 to 0.8 +- 1.0 ng/mL (p = 0.003) and from 3.4 +- 2.3 to 2.9 +- 2.0 ng/mL (p = 0.020), respectively, whereas the amount of increases in serum CPR levels after breakfast remained unchanged between low and high FPG (2.0 +- 1.8 vs. 1.9 +- 1.7 ng/mL, p = 0.78). On the other hand, the amount of increases in serum proinsulin levels after breakfast and the post-breakfast proinsulin/CPR ratio significantly diminished from 35.8 +- 68.5 to 19.2 +- 34.9 pmol/L (p = 0.010) and from 15.2 +- 2.9 to 10.8 +- 3.3 (p < 0.001; Figure 2b), respectively. Furthermore, post-breakfast delta IAUCG-4h correlated positively with a decrease in fasting FFA levels (r = 0.801, p < 0.001; Figure 3a) and in the post-breakfast proinsulin/CPR ratio (r = 0.785, p < 0.001; Figure 3b), respectively.

Management information
Registered date
2015 Year 05 Month 20 Day
Last modified on
2016 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020436

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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