This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

START-J: SiTAgliptin in eldeRly Trial in Japan (START-J)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Japan Association for Diabetes Education and Care
ClinicalTrials.gov Identifier:
NCT01183104
First received: August 16, 2010
Last updated: March 3, 2017
Last verified: March 2017
August 16, 2010
March 3, 2017
August 2010
January 2015   (Final data collection date for primary outcome measure)
  • Change From Baseline in HbA1c at 52 W [ Time Frame: Baseline and 52 W ]
  • Number of Participants With Hypoglycaemia [ Time Frame: From baseline to 52 W ]
HbA1c change from baseline as efficacy and incidence of hypoglycaemia as safety [ Time Frame: From randomization to 52 W ]
Complete list of historical versions of study NCT01183104 on ClinicalTrials.gov Archive Site
  • The Number of Participants Achieving HbA1c < 6.9 % [ Time Frame: 52 W ]
  • Change From Baseline in HOMA-β at 52 W [ Time Frame: Baseline and 52 W ]
    β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]
  • Change From Baseline in Insulin/Proinsulin Ratio at 52 W [ Time Frame: Baseline and 52 W ]
  • Change From Baseline in Body Weight at 52 W [ Time Frame: Baseline and 52 W ]
Comparison between two groups in the following parameters at 52W as well as 24 W as interim analysis [ Time Frame: 24W and 52W ]
1.The proportion of subjects achieving HbA1c levels <6.9% and <7.4% 2.6-point SMBG daily profile 3.Beta cell functions 4.Incidence of hypoglycaemia 5.Body weight change from baseline 6.Time to rescue therapy with the comparator drug as combination sitagliptin+glimeripirde 7.Adverse events 8.Standard laboratory tests for safety 9.Subanalysis according to stratum of baseline parameters
Not Provided
Not Provided
 
START-J: SiTAgliptin in eldeRly Trial in Japan
Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes
The purpose of this study is to compare the efficacy and the safety of sitagliptin and glimepiride in drug naïve elderly patients with Type 2 diabetes as evaluated by HbA1c change from baseline at 52 W as efficacy and incidence of hypoglycemia from randomization to 52 W as safety. The clinical hypotheses are non-inferiority of sitagliptin to glimepiride in efficacy as judged by HbA1c change from baseline at 52 W and superiority of sitagliptin to glimepiride in safety as judged by incidence of hypoglycemia in drug naïve elderly patients with T2DM. In addition, comparison of efficacy is extended to 104 W.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Sitagliptin
    Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
  • Drug: Glimepiride
    Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
  • Experimental: Sitagliptin
    Intervention: Drug: Sitagliptin
  • Active Comparator: Glimepiride
    Intervention: Drug: Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
305
January 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with type 2 diabetes who are oral hypoglycemic agent naive or, α-glucosidase inhibitor or biguanide monotherapy (to be washed out 4 weeks prior to randomization)
  2. Signed informed consent obtained before any trial-related activities
  3. Treatment with diet and exercise for 12 weeks and longer at screening
  4. Age =>60 y.o.
  5. Male and Female
  6. HbA1c 6.9%=< <8.9%

Exclusion Criteria:

  1. Active proliferative retinopathy or maculopathy requiring treatment
  2. Liver dysfunction (>x2 of upper normal limit), moderate or severe renal dysfunction(serum Cr>1.5mg/dL in male, Cr>1.3mg/dL in female, eGFR<30), severe cardiac disease (NYHA III or IV), malignancy or uncontrolled hypertension (treated or untreated) as judged by the Investigator
  3. Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
  4. Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
  5. Previous history of severe allergy to pharmaceutical products
  6. Systemic glucocorticoids users or potential users
  7. Suspected type 1 diabetes (including slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
  8. Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01183104
START-J
UMIN000004047 ( Other Identifier: UMIN )
Yes
Not Provided
Not Provided
Japan Association for Diabetes Education and Care
Japan Association for Diabetes Education and Care
Merck Sharp & Dohme Corp.
Principal Investigator: Yasuo Terauchi, M.D., Ph.D. Yokohama City University School of Medicine
Japan Association for Diabetes Education and Care
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP