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Completed

NCT Number: NCT01183104

START-J: SiTAgliptin in eldeRly Trial in Japan

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Japan Association for Diabetes Education and Care

Chiyoda-Ku, Tokyo, 102-0083, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%=< <8.9%

Exclusion criteria

  • 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

Treatment and study plan

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).

Glimepiride

Drug

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

Primary outcomes

  1. Change From Baseline in HbA1c at 52 W

    Time frame: Baseline and 52 W

  2. Number of Participants With Hypoglycaemia

    Time frame: From baseline to 52 W

Secondary outcomes

  1. The Number of Participants Achieving HbA1c < 6.9 %

    Time frame: 52 W

  2. 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]

  3. Change From Baseline in Insulin/Proinsulin Ratio at 52 W

    Time frame: Baseline and 52 W

  4. Change From Baseline in Body Weight at 52 W

    Time frame: Baseline and 52 W

Sponsors and collaborators

Lead sponsor

Japan Association for Diabetes Education and Care

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: START-J

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 17, 2010
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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