N/A
Completed N=305
START-J: SiTAgliptin in eldeRly Trial in Japan
Source: ClinicalTrials.gov NCT01183104 ↗Enrolled (actual)
305
Serious AEs
5.5%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline in HbA1c at 52 W — -0.66; -0.77 percent — p=0.087
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c at 52 W |
-0.66; -0.77 | 0.087 |
| PRIMARY Number of Participants With Hypoglycaemia |
7; 23 | 0.002 sig |
| SECONDARY The Number of Participants Achieving HbA1c < 6.9 % |
89; 86 | 1.0 |
| SECONDARY Change From Baseline in HOMA-β at 52 W |
10.2; 23.7 | 0.030 sig |
| SECONDARY Change From Baseline in Insulin/Proinsulin Ratio at 52 W |
-0.049; -0.002 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at 52 W |
-0.367; 0.309 | 0.043 sig |
Eligibility Criteria
Inclusion Criteria
- 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)
- Signed informed consent obtained before any trial-related activities
- Treatment with diet and exercise for 12 weeks and longer at screening
- Age =>60 y.o.
- Male and Female
- HbA1c 6.9%= 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
- Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator
- Recurrent hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
- Previous history of severe allergy to pharmaceutical products
- Systemic glucocorticoids users or potential users
- Suspected type 1 diabetes (including slowly progressive insulin dependent diabetes mellitus) or positive anti-glutamic acid decarboxylase antibody
- Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Data sourced from ClinicalTrials.gov (NCT01183104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.