NCT02438397

Brief Summary

the study objective: to explore the efficacy of acarbose and metformin on glucose fluctuations as add on therapy in type 2 diabetes patients inadequately controlled with premix insulin.

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
80

participants targeted

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

Timeline
Completed

Started Dec 2014

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, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

1.8 years

First QC Date

May 5, 2015

Last Update Submit

May 5, 2015

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • MAGE: mean amplitude of glycemic excursion/MODD: mean of daily differences

    12 weeks after treatment

Study Arms (2)

metformin+premix insulin

ACTIVE COMPARATOR

metformin:500mg tid

Drug: premix insulinDrug: metformin

acarbose+premix insulin

EXPERIMENTAL

acarbose:100mg tid

Drug: premix insulinDrug: Acarbose

Interventions

premix insulinDRUG

Premix-insulin(human insulin or analog) treatment will continue

Also known as: human insulin or analog
acarbose+premix insulinmetformin+premix insulin
metforminDRUG

500 mg tid by Merck

Also known as: glucophage
metformin+premix insulin
AcarboseDRUG

100mg tid by Bayer

Also known as: Glucobay
acarbose+premix insulin

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed T2DM patients (WHO, 1999).
  • Premix Insulin therapy for more than 3 months, the daily dosage of insulin \>20IU and \<1IU/kg
  • ≤Age ≤ 70 years old, male or female
  • ≤ HbA1c ≤10.0%
  • ≤ BMI ≤ 35 kg/m2
  • Written Informed consent

You may not qualify if:

  • Subject with type 1 diabetes or gestational diabetes mellitus and other specific types DM
  • Those who can not tolerate AGI or who is suffering GI disease
  • Metformin contradiction
  • Concomitant 2 oral anti-diabetes medicine, or 1 OAD with maximum dose
  • Subject with repeated severe hypoglycemia and/or unawareness of hypoglycemia
  • Known or suspected allergy to trial product(s) or related products
  • Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial
  • Impaired liver function,
  • Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, cancer, TB, acute infection
  • Uncontrolled hypertension
  • Concomitant treatment which influences blood glucose
  • Impaired renal function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 6th affliliated hospital of Shanghai Jiaotong university

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Related Publications (1)

  • Gao F, Li C, Wang Y, Lu J, Lu W, Zhou J, Yin J, Ma X. Growth differentiation factor 15 is not associated with glycemic control in patients with type 2 diabetes mellitus treated with metformin: a post-hoc analysis of AIM study. BMC Endocr Disord. 2022 Oct 22;22(1):256. doi: 10.1186/s12902-022-01176-3.

    PMID: 36273168DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

InsulinMetforminAcarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsBiguanidesGuanidinesAmidinesOrganic ChemicalsTrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Weiping Jia, doctor

    the 6th affiliated hospital of Shanghai Jiaotong university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jian Zhou, doctor

CONTACT

18930172033zhoujian8337@126.com

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
Professor,chief of endocrinology department

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 8, 2015

Study Start

December 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

CN(1)