START-J: SiTAgliptin in eldeRly Trial in Japan
This study is currently recruiting participants.
Verified March 2012 by Japan Association for Diabetes Education and Care
Sponsor:
Japan Association for Diabetes Education and Care
Collaborator:
Merck
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
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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:
- Patients with type 2 diabetes who are OHA naive or, a-GI or BG 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, GFR<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 SPIDDM) or positive anti-GAD antibody
- Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis
Contacts and Locations
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
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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Sitagliptin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on October 17, 2012
