START-J: SiTAgliptin in eldeRly Trial in Japan

NCT01183104 | Completed Results DMC

• 2 other identifiers: START-JUMIN000004047
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; Sitagliptin; Glimepiride; Elderly patients; Japanese

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in HbA1c at 52 W

  Baseline and 52 W

• Number of Participants With Hypoglycaemia

  From baseline to 52 W

Secondary Outcomes (4)

• The Number of Participants Achieving HbA1c < 6.9 %

  52 W

• Change From Baseline in HOMA-β at 52 W

  Baseline and 52 W

• Change From Baseline in Insulin/Proinsulin Ratio at 52 W

  Baseline and 52 W

• Change From Baseline in Body Weight at 52 W

  Baseline and 52 W

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Drug: Sitagliptin

Glimepiride

ACTIVE COMPARATOR

Drug: Glimepiride

Interventions

Sitagliptin DRUG

Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=\< \<50).

Sitagliptin

Glimepiride DRUG

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

Glimepiride

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%=\< \<8.9%

You may not qualify if:

• Active proliferative retinopathy or maculopathy requiring treatment
• 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
• 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

Sponsors & Collaborators

• Japan Association for Diabetes Education and Care: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Japan Association for Diabetes Education and Care

Chiyoda-Ku, Tokyo, 102-0083, Japan

Location

Related Publications (1)

• 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.

  PMID: 28294488 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Prof. Yasuo Terauchi
• Organization: Japan Association for Diabetes Education and Care

terauchi-tky@umin.ac.jp

+81-3-3514-1721

Study Officials

• Yasuo Terauchi, M.D., Ph.D.

  Yokohama City University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 17, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Locations

JP (1)