START-J: SiTAgliptin in eldeRly Trial in Japan

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Japan Association for Diabetes Education and Care
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 15, 2012
Last verified: March 2012

August 16, 2010
March 15, 2012
August 2010
December 2014   (final data collection date for primary outcome measure)
HbA1c change from baseline as efficacy and incidence of hypoglycaemia as safety [ Time Frame: From randomization to 52 W ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01183104 on ClinicalTrials.gov Archive Site
Comparison between two groups in the following parameters at 52W as well as 24 W as interim analysis [ Time Frame: 24W and 52W ] [ Designated as safety issue: Yes ]
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
Same as current
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 T2DM 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 104W.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Sitagliptin, Glimepiride

Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; GFR 30=< <50).

Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg

  • Experimental: Sitagliptin
    Intervention: Drug: Sitagliptin, Glimepiride
  • Active Comparator: Glimepiride
    Intervention: Drug: Sitagliptin, Glimepiride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with type 2 diabetes who are OHA naive or, a-GI or BG 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, GFR<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 SPIDDM) or positive anti-GAD antibody
  8. Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Both
60 Years and older
No
Contact: Yasuo Terauchi, M.D., Ph.D. 81-45-787-2639 terauchi@yokohama-cu.ac.jp
Japan
 
NCT01183104
START-J, UMIN000004047
Yes
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 2012

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