CompletedPhase 4

Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes

China300 participantsStarted 2015-03

Plain-language summary

The main purpose of this study is to evaluate whether saxagliptin or (and vitamin D3) with metformin (and insulin) therapy can better protect islet β cell function than metformin(and insulin) .

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Volunteer to participate in the study with informed consent;
✓. The LADA patients to be included in this study are defined as:

Exclusion criteria

✕. Pregnancy, breastfeeding or planned pregnancy within two years;
✕. Gestational diabetes mellitus or other specific types of diabetes;
✕. Allergic to saxagliptin, vitamin D3 and their excipient;
✕. Treatment with any anti-diabetic medication other than insulin in the last 8 weeks prior to randomization;
✕. Use of systemic corticosteroids therapy (oral, intravenous) continuously for more than 7 days over the past 6 months;
✕. Treatment with cytochrome P450 3A4/5 (CYP450 3A4/5) inhibitor;
✕. Alanine aminotransferase (ALT) or aspartate transaminase(AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit;
✕. Creatinine levels ≧ 1.5 mg/dL(132μmol/L) for males and ≧ 1.4 mg/dL (123μmol/L) for females or creatinine clearance ≦ 50 mL/min;

What they're measuring

Absolute changes from baseline in Fasting C-peptide levels at week 104.

Timeframe: From baseline to 104 week

Trial details

NCT IDNCT02407899

SponsorSecond Xiangya Hospital of Central South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-30

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