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
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Drug: Sitagliptin, Glimepiride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of Sitagliptin and Glimepiride in Elderly Japanese Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Japan Association for Diabetes Education and Care:

Primary Outcome Measures:
  • HbA1c change from baseline as efficacy and incidence of hypoglycaemia as safety [ Time Frame: From randomization to 52 W ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 900
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin 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

Active Comparator: Glimepiride 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


  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183104

Contacts
Contact: Yasuo Terauchi, M.D., Ph.D. 81-45-787-2639 terauchi@yokohama-cu.ac.jp

Locations
Japan
Japan Association for Diabetes Education and Care Recruiting
Chiyoda-Ku, Tokyo, Japan, 102-0083
Contact: Nobuyuki Shihara, Ph.D.    81-3-3514-1721    shihara@nittokyo.or.jp   
Sponsors and Collaborators
Japan Association for Diabetes Education and Care
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Yasuo Terauchi, M.D., Ph.D. Yokohama City University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Japan Association for Diabetes Education and Care
ClinicalTrials.gov Identifier: NCT01183104     History of Changes
Other Study ID Numbers: START-J, UMIN000004047
Study First Received: August 16, 2010
Last Updated: March 15, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Association for Diabetes Education and Care:
Type 2 Diabetes
Sitagliptin
Glimepiride
Elderly patients
Japanese

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Sitagliptin
Anti-Arrhythmia Agents
Cardiovascular Agents
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014