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

NCT01159847 | Completed Phase 1 DMC

• 1 other identifier: EFSD DPP-Ⅳ LADA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

sitagliptin; LADA; C-Peptide; Flow Cytometry; ELISPOT

Outcome Measures

Primary Outcomes (1)

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

  1. The assessment of the change of β cell function in patients with LADA treated with sitagliptin plus insulin by the standardized mixed meal stimulation test and insulin sensitivity by HOMA-IR. 2. The assessment of the change of insulin sensitivity in LADA patients by sequential insulin infusion with the euglycemic glucose clamp technique.

  2 years

Secondary Outcomes (5)

• The possible immunomodulatory effects of sitagliptin on LADA patients

  2 years

• The possible immunomodulatory effects of sitagliptin on LADA patients

  2 years

• The possible immunomodulatory effects of sitagliptin on LADA patients

  2 years

• The possible immunomodulatory effects of sitagliptin on LADA patients

  2 years

• The possible immunomodulatory effects of sitagliptin on LADA patients

  2 years

Study Arms (2)

Sitagliptin

EXPERIMENTAL

Patients will receive insulin therapy with sitagliptin.

Drug: sitagliptin; Drug: Insulin

Insulin

ACTIVE COMPARATOR

Patients will receive insulin therapy without sitagliptin.

Drug: Insulin

Interventions

sitagliptin DRUG

sitagliptin tablet,100 mg p.o. qd,2 year

Also known as: Januvia

Sitagliptin

Insulin DRUG

Insulin; Sitagliptin

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Foundation for the Study of Diabetes: lead
• Chinese Medical Association: collaborator
• Eli Lilly and Company: collaborator

Study Sites (1)

Diabetes Center, Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

Related Publications (28)

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  BACKGROUND

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• Yang L, Liang H, Liu X, Wang X, Cheng Y, Zhao Y, Liu L, Huang G, Wang X, Zhou Z. Islet Function and Insulin Sensitivity in Latent Autoimmune Diabetes in Adults Taking Sitagliptin: A Randomized Trial. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1529-e1541. doi: 10.1210/clinem/dgab026.

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• Zhao Y, Yang L, Xiang Y, Liu L, Huang G, Long Z, Li X, Leslie RD, Wang X, Zhou Z. Dipeptidyl peptidase 4 inhibitor sitagliptin maintains beta-cell function in patients with recent-onset latent autoimmune diabetes in adults: one year prospective study. J Clin Endocrinol Metab. 2014 May;99(5):E876-80. doi: 10.1210/jc.2013-3633. Epub 2014 Jan 16.

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Sitagliptin Phosphate; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Zhiguang Zhou, M.D., Ph.D.

  Diabetes Center, Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Endocrinology

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: July 12, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

CN (1)