NCT02920801

Brief Summary

In this study, the investigators aim to investigate whether saxagliptin modulate endothelial progenitor cells number and flow-mediated dilation in newly diagnosed, treatment-naive type 2 diabetic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

September 29, 2016

Last Update Submit

September 30, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

saxagliptinendothelial progenitor cellflow-mediated dilation

Outcome Measures

Primary Outcomes (2)

  • endothelial progenitor cell

    12weeks

  • flow-mediated dilation

    12weeks

Secondary Outcomes (5)

  • HbA1c

    12weeks

  • fasting blood glucose

    12weeks

  • 2 hour postprandial blood glucose

    12weeks

  • liver function test

    12weeks

  • renal function test

    12weeks

Study Arms (2)

saxagliptin group

EXPERIMENTAL

saxagliptin group consumed saxagliptin 5mg per day for 12 week

Drug: saxagliptin

metformin group

ACTIVE COMPARATOR

metformin group consumed metformin 1500mg per day for 12 week

Drug: Metformin

Interventions

saxagliptinDRUG

5mg per day for 12 weeks

saxagliptin group
MetforminDRUG

1500mg per day for 12 weeks

metformin group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed type 2 diabetics (diagnosis were made according to the American Diabetes Association Guideline \[19\] ), treatment naive, age 30-75, hemoglobin A1c (HbA1c) ≥6.5%, fasting c-peptide \>1.0ng/L

You may not qualify if:

  • pregnancy or lactation, smoker, acute disease or infection, chronic renal disease (estimated glomerular filtration rate \<60 mL/min/1.73m2), live enzymes 3 times above the normal range, positive islet autoantibody, fasting c-peptide \<1.0ng/L, severe hypertriglyceridemia (triglyceride \>5.6mmol/L), cardiovascular events or surgery within 3 months, taking glucocorticoid, history of acute or chronic pancreatitis, pancreatic tumor, severe cardiac or pneumonic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fang Li

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptinMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

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
associate professor

Study Record Dates

First Submitted

September 29, 2016

First Posted

September 30, 2016

Study Start

December 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 3, 2016

Record last verified: 2016-09

Locations

CN(1)