Status:
COMPLETED
Protective Effects of Sitagliptin on β Cell Function in Patients With Adult-onset Latent Autoimmune Diabetes (LADA)
Lead Sponsor:
European Foundation for the Study of Diabetes
Collaborating Sponsors:
Chinese Medical Association
Eli Lilly and Company
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
25-70 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Adult-onset latent autoimmune diabetes (LADA), etiologically belongs to type 1 diabetes (T1D), is characterized by the presence of islet autoantibodies, such as islet cell antibody (ICA) and glutamic ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01159847
Start Date
January 1 2010
End Date
December 1 2012
Last Update
July 31 2018
Active Locations (1)
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1
Diabetes Center, Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011