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START-J: SiTAgliptin in eldeRly Trial in Japan (START-J)

This study has been completed.
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 3, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Type 2 Diabetes
Drug: Sitagliptin
Drug: Glimepiride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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:
  • Change From Baseline in HbA1c at 52 W [ Time Frame: Baseline and 52 W ]
  • Number of Participants With Hypoglycaemia [ Time Frame: From baseline to 52 W ]

Secondary Outcome Measures:
  • The Number of Participants Achieving HbA1c < 6.9 % [ Time Frame: 52 W ]
  • Change From Baseline in HOMA-β at 52 W [ Time Frame: Baseline and 52 W ]
    β cell function is measured by the Homeostatic Model Assessment(HOMA-β). HOMA β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]

  • Change From Baseline in Insulin/Proinsulin Ratio at 52 W [ Time Frame: Baseline and 52 W ]
  • Change From Baseline in Body Weight at 52 W [ Time Frame: Baseline and 52 W ]

Enrollment: 305
Study Start Date: August 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin Drug: Sitagliptin
Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
Active Comparator: Glimepiride Drug: Glimepiride
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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

Locations
Japan
Japan Association for Diabetes Education and Care
Chiyoda-Ku, Tokyo, Japan, 102-0083
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:
Responsible Party: Japan Association for Diabetes Education and Care
ClinicalTrials.gov Identifier: NCT01183104     History of Changes
Other Study ID Numbers: START-J
UMIN000004047 ( Other Identifier: UMIN )
Study First Received: August 16, 2010
Results First Received: December 5, 2016
Last Updated: March 3, 2017

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

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

ClinicalTrials.gov processed this record on May 22, 2017