START-J: SiTAgliptin in eldeRly Trial in Japan

Type 2 Diabetes Clinical Trial

— START-J  

Official title:

Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183104
• Other study ID #: START-J
• Secondary ID: UMIN000004047
• Status: Completed
• Phase: N/A
• First received: August 16, 2010
• Last updated: March 31, 2015
• Start date: August 2010
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Japan Association for Diabetes Education and Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Japan	Japan Association for Diabetes Education and Care	Chiyoda-Ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Japan Association for Diabetes Education and Care	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c change from baseline as efficacy and incidence of hypoglycaemia as safety		From randomization to 52 W	Yes
Secondary	Comparison between two groups in the following parameters at 52W as well as 24 W as interim analysis	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	24W and 52W	Yes