NCT03039075

Brief Summary

Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are equal to Glucophage is unclear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_4 diabetes-mellitus

Timeline
Completed

Started Nov 2016

Typical duration for phase_4 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

November 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

November 10, 2016

Last Update Submit

July 22, 2019

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Changes of HbA1c

    Efficacy

    12 weeks

Secondary Outcomes (4)

  • Incidence of nausea, diarrhea

    12 weeks

  • Changes of weight

    12 weeks

  • Changes of intestinal flora proportion

    12 weeks

  • Changes of LDL, HDL, TG, TC

    12 weeks

Study Arms (2)

Metformin SR Tablet

ACTIVE COMPARATOR

Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD

Drug: Metformin SR Tablet

Glucophage

ACTIVE COMPARATOR

The original drug of metformin

Drug: Metformin SR Tablet

Interventions

Metformin SR TabletDRUG

Metformin SR Tablet made in Conquer pharmaceutical co., LTD

Also known as: DuLeNing
GlucophageMetformin SR Tablet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Well informed of the procedures of this trial and informed consent is obtained
  • Voluntarily accept standardized treatment 3.18-75 years old, gender is not limited
  • Newly diagnosed as type 2 diabetes and have not yet received any hypoglycemic therapy 5.Unable to control the blood glucose by diet and exercise: 7.5% ≤HbA1c ≤11.0%, in screening and before randomization 6.BMI: 19\~35 kg/m2 7.Well compliance 8.Capable of self blood Glucose monitoring

You may not qualify if:

  • Pregnant or lactating
  • Type 1 diabetes
  • Poor blood glucose control（HbA1c\>11%）
  • A history of malignant tumor
  • Abnormal liver or renal function (defined as alanine aminotransferase(ALT)\>2.5 times higher than normal range,or eGFR\<45 mL/min per 1•73 m²)
  • Poor blood pressure control \[systolic blood pressure(SBP)\>180mmHg,or diastolic blood pressure(DBP)\>110mmHg\]
  • With severe heart disease,cardiac function worse than grade II,anemia(Hb\<9.0g/d1)
  • Continuous use of antidiabetic drugs more than one week in recent 3 months
  • History of acute metabolic complications in recent 6 months
  • Blood routine test indicates that the white blood cell count(WBC) \<3\*109/l
  • Body Mass Index(BMI)\<18.5 or ≥35kg/m2
  • Drug or alcohol abuse
  • Accompanying mental disorder who can't collaborate
  • Abnormal digestion and absorption function
  • Other endocrine diseases
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (2)

  • Buse JB, DeFronzo RA, Rosenstock J, Kim T, Burns C, Skare S, Baron A, Fineman M. The Primary Glucose-Lowering Effect of Metformin Resides in the Gut, Not the Circulation: Results From Short-term Pharmacokinetic and 12-Week Dose-Ranging Studies. Diabetes Care. 2016 Feb;39(2):198-205. doi: 10.2337/dc15-0488. Epub 2015 Aug 18.

    PMID: 26285584BACKGROUND

  • Xu T, Brandmaier S, Messias AC, Herder C, Draisma HH, Demirkan A, Yu Z, Ried JS, Haller T, Heier M, Campillos M, Fobo G, Stark R, Holzapfel C, Adam J, Chi S, Rotter M, Panni T, Quante AS, He Y, Prehn C, Roemisch-Margl W, Kastenmuller G, Willemsen G, Pool R, Kasa K, van Dijk KW, Hankemeier T, Meisinger C, Thorand B, Ruepp A, Hrabe de Angelis M, Li Y, Wichmann HE, Stratmann B, Strauch K, Metspalu A, Gieger C, Suhre K, Adamski J, Illig T, Rathmann W, Roden M, Peters A, van Duijn CM, Boomsma DI, Meitinger T, Wang-Sattler R. Effects of metformin on metabolite profiles and LDL cholesterol in patients with type 2 diabetes. Diabetes Care. 2015 Oct;38(10):1858-67. doi: 10.2337/dc15-0658. Epub 2015 Aug 5.

    PMID: 26251408BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Qifu Li, phD

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

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
Primary Investigator

Study Record Dates

First Submitted

November 10, 2016

First Posted

February 1, 2017

Study Start

November 1, 2016

Primary Completion

October 1, 2018

Study Completion

November 1, 2018

Last Updated

July 24, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)