NCT01758471

Brief Summary

This study is aimed to investigate the effect of acarbose on intestinal microbiome and incretins, therefore to explore the new pathways or new targets to treat type 2 diabetes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_4 type-2-diabetes

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 1, 2013

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

December 24, 2012

Last Update Submit

December 24, 2012

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetesgut microbiomeincretinSulfonylureaα-glucosidase inhibitor

Outcome Measures

Primary Outcomes (1)

  • euglycemia

    3 months

Study Arms (2)

Acarbose

EXPERIMENTAL

The minimum dosage of acarbose in this study is 100mg tid p.o.(oral) for 3 month. With this dosage, patients should have similar glycemic control with those using glipizide, that is FBG(fasting blood glucose)\<7.0,PBG(postprandial blood glucose)\<10.0

Drug: Acarbose

glipizide

ACTIVE COMPARATOR

There is no fixed dosage of glipizide to control hyperglycemia for patients in this group. As long as the targeted blood glucose concentration is reached, FBG\< 7.0, PBG\< 10.0, patients will have the least dosage of glipizide according to their glucose level.

Drug: Glipizide

Interventions

GlipizideDRUG

glipizide 5mg per pill 5mg tid p.o. for 3 month

glipizide
AcarboseDRUG

Acarbose 50mg per pill 100mg to 150mgtid p.o.（oral） for 3 month

Also known as: glucobay
Acarbose

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Newly diagnosed Type 2 Diabetes, without any previous drug treatment,
  • mmol/l \<=FBG\<=13.O mmol/l, HbA1C \<=10%
  • Body mass index (BMI) \< 35kg/m2 (inclusive);
  • Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
  • Having good study compliance

You may not qualify if:

  • Intestinal surgery or recent abdominal surgery within 1 year
  • Taken immunosuppressive agents, steroid,antidiarrhea agents, antibiotics and other gastrointestinal motility agents within 3 months
  • Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR \< 60ml/min)
  • Other severe conditions which will put the patients in high risk during the study
  • Any clinically significant allergic disease
  • Women in pregnancy or under breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Clinic Center for Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Institute for Endocrine and Metabolic Diseases

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • Ni M, Chen Y, Gu W, Zhang Y, Xu M, Gu Y, Chen Y, Zhu Y, Wang X, Luo Y, Xu Y, Lin X, Zeng YA, Liu R, Wang J. Association Between Circulating Gremlin 2 and beta-Cell Function Among Participants With Prediabetes and Type 2 Diabetes. J Diabetes. 2025 Apr;17(4):e70090. doi: 10.1111/1753-0407.70090.

    PMID: 40270326DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

GlipizideAcarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sulfonylurea CompoundsSulfonesSulfur CompoundsOrganic ChemicalsTrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Guang Ning, M.D. Ph.D.

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Ning, M.D. Ph.D.

CONTACT

86-021-64370045guangning@medmail.com.cn

Yanyun Gu, M.D. Ph.D.

CONTACT

86-021-64370045guyanyun@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Director of Shanghai Institute for Endocrine and Metabolic Diseases

Study Record Dates

First Submitted

December 24, 2012

First Posted

January 1, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

January 1, 2013

Record last verified: 2012-12

Locations

CN(1)