Study on Exploring the Effect of DPP-4 Inhibitors on β-cell Function by Using the Two-step Hyperglycemic Clamp

NCT02386943 | Unknown Phase 4 DMC

• 1 other identifier: CCEMD022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to explore the effects of two DPP-4 inhibitors(Sitagliptin, Saxagliptin) on β- and α-cell function, as well as the incretin effect.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• β-cell function (measurement of insulin and c-peptide during the clamp study)

  The primary endpoints are the effects of DPP-4 inhibitors on β-cell function, with the measurement of insulin and c-peptide during the clamp study.

  15 months

Secondary Outcomes (2)

• α-cell function (measurement of glucagon during the clamp study)

  15 months

• Incretin effect (measurement of active GLP-1 during the clamp study)

  15 months

Study Arms (3)

Sitagliptin

EXPERIMENTAL

Subjects are assigned to take one pill of sitagliptin(100mg po once) at 7am on experimental day,then the two-step hyperglycaemic clamp is initiated at 9am.

Drug: Sitagliptin

Saxagliptin

EXPERIMENTAL

Subjects are assigned to take one pill of saxagliptin(5mg po once) at 7am on experimental day,then the two-step hyperglycaemic clamp is initiated at 9am.

Drug: Saxagliptin

Blank control

EXPERIMENTAL

Subjects take no medication for blank control at experimental day,then the two-step hyperglycaemic clamp is initiated at 9am.

Drug: Blank control

Interventions

Sitagliptin DRUG

100mg po once.

Also known as: Januvia

Sitagliptin

Saxagliptin DRUG

5mg po once.

Also known as: Onglyza

Saxagliptin

Blank control DRUG

No medication is taken.

Also known as: Baseline

Blank control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old;
• Diagnosed as T2DM according to the 1999 World Health Organization criteria within 2 years;
• Free of any antihypoglycemia therapy ever;
• No weight fluctuation greater than 5% in late 3 months.
• Understand and voluntarily sign an informed consent document.
• Good study compliance.

You may not qualify if:

• With any significant medical condition (within 3 years), laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study;
• Used any prescribed systemic or topical medication within 30 days of the first dose administration;
• Any medical or surgical conditions possibly affecting study drug absorption, distribution, metabolism and excretion;
• Participated in a clinical study involving administration of an investigational drug within 90 days preceding the first dose administration or within five half-lives of the first dose administration (whichever is longer);
• Donated blood or plasma or had any other significant blood loss within 2 months preceding the first dose administration;
• History of multiple drug allergies;
• Any clinically significant allergic disease;
• Recently drug or alcohol abuse (\>35 unit/week, 1 unit=8g alcohol @ 1 standard drink @ 250ml beer @ 140ml wine @ 25ml strong alcohol drink like whiskey); Smokers or users of other tobacco products in the 3 months prior to screening.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; saxagliptin; BaseLine dental cement

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Guang Ning, MD. PHD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Ning, MD. PHD

CONTACT

+86021-64370045

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the vice-president of Shanghai Jiao Tong University Affiliated Ruijin Hospital

Study Record Dates

• First Submitted: March 7, 2015
• First Posted: March 12, 2015
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 12, 2015

Record last verified: 2015-03

Locations

CN (1)