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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Foundation for the Study of Diabetes
• Collaborators: Chinese Medical Association; Eli Lilly and Company
• Treatments: Sitagliptin Phosphate

Criteria

Inclusion Criteria:

1. Diabetes diagnosed according to the report of WHO in 1999.

2. Age at onset between 25~70 years.

3. Disease duration of less than 3 year.

4. No ketoacidosis within the first 6 months after diagnosis of diabetes.

5. GADA positive twice within one month.

6. Fasting C-peptide (FCP) level of 0.2 nmol/L or more.

Exclusion Criteria:

1. Insulin requirements more than 0.8 units/kg/day.

2. Evidence of chronic infection or acute infection affected blood glucose control within 4 weeks prior to visit 1.

3. History of any malignancy.

4. Pregnancy, breastfeeding or planned pregnancy within two years.

5. Secondary diabetes.

6. Congestive heart failure requiring pharmacologic treatment.

7. 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.

8. Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.