The Effect of Saxagliptin on Glucose Fluctuation and Immune Regulation in Patients With Type 1 Diabetes

NCT02307695 | Unknown Phase 4 DMC

• 1 other identifier: 2014-SR-123
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate whether saxagliptin could reduce the fluctuation of glycemia and improve the glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon secretion, improving beta cell function, and re-regulating of the T cell immune system.

Conditions

Type 1 Diabetes

Keywords

Saxagliptin; Type 1 Diabetes; Glycemic variability; C-Peptide

Outcome Measures

Primary Outcomes (1)

• Change of Mean amplitude of glycemic excursions (MAGE) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone by continuous glucose monitoring system (CGMS)

  24 week

Secondary Outcomes (3)

• Change of C-peptide area under the curve (AUC C-peptide) or fasting C-peptide from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone by 3-hour mixed meal tolerance test(MMTT)

  24 week

• Change of Haemoglobin A1c (HbA1c) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone

  24 week

• Change of insulin dosage (U/kg/d) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone

  24 week

Study Arms (2)

insulin+Saxagliptin

EXPERIMENTAL

Patients who have diagnosed type 1 diabetes are assigned to receive Saxagliptin tablets 5 mg and insulin for 24-week.

Drug: Saxagliptin; Drug: Insulin

insulin

ACTIVE COMPARATOR

Patients who have diagnosed type 1 diabetes only use insulin.

Drug: Insulin

Interventions

Saxagliptin DRUG

saxagliptin 5 mg p.o. qd, 24 week

Also known as: Onglyza, DPP-IV inhibitor

insulin+Saxagliptin

Insulin DRUG

Patients will be treated according to routine clinical practice at the discretion of the treating physician.

insulin; insulin+Saxagliptin

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures;
• Diagnosed with type 1 diabetes;
• Men or women who are 12 to 65 years of age at time of consenting upon Visit 1.;
• Positivity for at least one of the four islet autoantibodies(IA-2A、IAA、GADA、ZnT8A);
• % ≤ HbA1c ≤10.0%.

You may not qualify if:

• type 2 diabetes；
• Evidence of chronic or acute complications of diabetes which is unstable and requires hospitalization；
• Evidence of disease stress；
• History of administration of any antihyperglycemic therapy (other than insulin) during the 12 weeks prior to Visit 1；
• Have a history of, or currently have, acute or chronic pancreatitis；
• Immunocompromised individuals such as patients that have undergone organ transplantation or patients diagnosed with HIV or patients with agranulocytosis；
• Evidence of chronic or acute infection；
• Active liver disease and/or significant abnormal liver function defined as Aspartate transaminase(AST) ≥3x Upper Limit of Normal(ULN) and/or Alanine aminotransferase (ALT) ≥3x Upper Limit of Normal(ULN)；
• History of unstable or rapidly progressing renal disease, creatinine clearance(CrCl) ≤50ml/min;
• Congestive heart failure defined as New York Heart Association (NYHA) class III or IV and/or left ventricular ejection fraction of ≤ 40%；
• Rheumatoid arthritis or other autoimmune disease(except AITD);
• Hypersensitivity to saxagliptin；
• History of drug allergy or allergic disease
• History of alcohol abuse, illegal drug abuse, mental disease or other disease which is not eligible for the study
• Pregnant or breastfeeding patients；

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

saxagliptin; Dipeptidyl-Peptidase IV Inhibitors; 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)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Tao Yang, MD/PhD

  First Affiliated Hospital, Nanjing Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Yang, MD/PhD

CONTACT

86-25-83718836; yangt@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Endocrinology & Metabolism

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

CN (1)