NCT02605772

Brief Summary

To investigate the Safety and Efficacy of Acarbose+Saxagliptin Compared With Metformin+Saxagliptin in Patients With Type 2 Diabetes,100 patients with T2DM will be enrolled in this study.They will randomly be assigned to Acarbose+Saxagliptin or Metformin+Saxagliptin group.HbA1c，fasting and postprandial C-peptide will be observed before and after the interventions.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2015

Status
unknown

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

First Submitted

Initial submission to the registry

November 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

November 12, 2015

Last Update Submit

November 16, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • redunction of Hemoglobin A1c (HbA1c) Levels (%) in two groups respectively after three months intervention

    HbA1c was measured by high performance liquid chromatography with an automated biochemistry analyzer (Roche, Switzerland).

    baseline(0 week), week twelve

Secondary Outcomes (2)

  • Proportion of patients who achieve target of HbA1c<6.5% in two groups respectively at the end of study

    baseline(0 week), week twelve

  • Difference of Homeostasis model assessment of insulin resistance (HOMA-IR) and Homeostasis model assessment beta cell function index (HOMA-β) between two groups after three months intervention

    baseline(0 week), week twelve

Study Arms (2)

metformin+Saxagliptin

EXPERIMENTAL

metformin 0.5g tablet Saxagliptin 5mg tablet metformin 0.5g three times a day for three months Saxagliptin 5mg one time a day for three months

Drug: MetforminDrug: Saxagliptin

acarbose+Saxagliptin

EXPERIMENTAL

acarbose 50mg tablet Saxagliptin 5mg tablet Saxagliptin 5mg one time a day for three months acarbose 100mg three times a day for three months

Drug: AcarboseDrug: Saxagliptin

Interventions

AcarboseDRUG

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Also known as: Glucobay
acarbose+Saxagliptin
MetforminDRUG

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Also known as: Glucophage
metformin+Saxagliptin
SaxagliptinDRUG

group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg

Also known as: ONGLYZA
acarbose+Saxagliptinmetformin+Saxagliptin

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed type 2 diabetes mellitus（course of disease less than one year） who has not receive drug treatment.
  • T2DM patients who has not receive drug treatment for three months at least.
  • HbA1c for 7.5-10%.

You may not qualify if:

  • New or worsening signs or symptoms of coronary heart disease
  • Medical history of active liver disease and kidney disease
  • Poorly controlled hypertension（systolic blood pressure\>160mmHg or diastolic blood pressure\>95mmHg）
  • A clinically important hematological disorder
  • A history of intolerance or hypersensitivity or any contraindication to study medications (including saxagliptin, metformin, acarbose)
  • Is pregnant or breast feeding or is expecting to conceive or donate eggs
  • A medical history of drug abuse
  • Can not be followed -up on time
  • Endocrinological diseases（eg： hyperthyroidism、hypothyroidisn and cushing syndrom）
  • Gastrointestinal diseases
  • Mental disorser
  • Hypoxic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AcarboseMetforminsaxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydratesBiguanidesGuanidinesAmidinesOrganic 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
principal investigator

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 16, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

March 1, 2017

Last Updated

November 18, 2015

Record last verified: 2015-11