Clinical trial NCT01183104: START-J: SiTAgliptin in eldeRly Trial in Japan
Official title: Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Sitagliptin
Glimepiride
Elderly patients
Japanese
Lead sponsor: Japan Association for Diabetes Education and Care
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-08-17
Enrollment: 305
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in HbA1c at 52 W
timeFrame: Baseline and 52 W
measure: Number of Participants With Hypoglycaemia
timeFrame: From baseline to 52 W
Secondary outcomes:
measure: The Number of Participants Achieving HbA1c < 6.9 %
timeFrame: 52 W
measure: Change From Baseline in HOMA-β at 52 W
timeFrame: Baseline and 52 W
measure: Change From Baseline in Insulin/Proinsulin Ratio at 52 W
timeFrame: Baseline and 52 W
measure: Change From Baseline in Body Weight at 52 W
timeFrame: Baseline and 52 W
Other outcomes:
Locations:
city: Chiyoda-Ku
country: Japan
facility: Japan Association for Diabetes Education and Care
state: Tokyo
Study officials:
affiliation: Yokohama City University School of Medicine
name: Yasuo Terauchi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terauchi Y, Yamada Y, Ishida H, Ohsugi M, Kitaoka M, Satoh J, Yabe D, Shihara N, Seino Y. Efficacy and safety of sitagliptin as compared with glimepiride in Japanese patients with type 2 diabetes mellitus aged >/= 60 years (START-J trial). Diabetes Obes Metab. 2017 Aug;19(8):1188-1192. doi: 10.1111/dom.12933. Epub 2017 Apr 12.