CompletedPhase 1/2

Protective Effects of Sitagliptin on β Cell Function in Patients With Adult-onset Latent Autoimmune Diabetes (LADA)

China30 participantsStarted 2010-01

Plain-language summary

The aim of this study is to investigate the protective effects of sitagliptin on β cell function in patients with adult-onset latent autoimmune diabetes (LADA) and its mechanisms.

Who can participate

Age range25 Years – 70 Years

SexALL

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Inclusion criteria

✓. Diabetes diagnosed according to the report of WHO in 1999.
✓. Age at onset between 25\~70 years.
✓. Disease duration of less than 3 year.
✓. No ketoacidosis within the first 6 months after diagnosis of diabetes.
✓. GADA positive twice within one month.
✓. Fasting C-peptide (FCP) level of 0.2 nmol/L or more.

Exclusion criteria

✕. Insulin requirements more than 0.8 units/kg/day.
✕. Evidence of chronic infection or acute infection affected blood glucose control within 4 weeks prior to visit 1.
✕. History of any malignancy.
✕. Pregnancy, breastfeeding or planned pregnancy within two years.
✕. Secondary diabetes.
✕. Congestive heart failure requiring pharmacologic treatment.
✕. Renal disease or renal dysfunction or diabetic nephropathy suggested by serum creatinine levels≥1.5 mg/dL (132μmol/L) for males and ≥1.4mg/dL (123μmol/L) for females or abnormal creatinine clearance at Visit 1.
✕. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.

What they're measuring

The effects of sitagliptin on β cell function and insulin sensitivity of LADA patients

Timeframe: 2 years

Trial details

NCT IDNCT01159847

SponsorEuropean Foundation for the Study of Diabetes

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-07

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