Metformin SR Tablet (DuLeNing) and Glucophage in Patients... | NCT03039075

Studies
Metformin SR Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes

NCT03039075

Sponsor

Chongqing Medical University

Status

Completed

Last Update Posted

Jul 24, 2019Actual

Enrollment

240Actual

Phase

Phase 4

Conditions

Diabetes Mellitus

Interventions

Metformin SR Tablet

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Oct 2018Actual

Completion Date

Nov 2018Actual

First Submitted Date

Nov 10, 2016

First Submission Date that Met QC Criteria

Jan 30, 2017

First Posted Date

Feb 1, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2019

Last Update Posted Date

Jul 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

To perform a RCT for the comparison between Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD and Glucophage .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Metformin SR Tablet	Drug	Metformin SR Tablet made in Conquer pharmaceutical co., LTD	Glucophage Metformin SR Tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of HbA1c	Efficacy	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidence of nausea, diarrhea	Safety	12 weeks
Changes of weight		12 weeks
Changes of intestinal flora proportion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

4.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

Exclusion Criteria:

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
Other chronic diseases needed long-term glucocorticoid treatment
With severe infection, immune dysfunction
A history of metformin allergies or allergic constitution

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Qifu Li, phD	First Affiliated Hospital of Chongqing Medical University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Chongqing Medical University		Chongqing	Chongqing Municipality	400016	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26285584	Background	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.
26251408

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases