Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)

NCT ID: NCT02947620

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-02-27

Brief Summary

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A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.

Detailed Description

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Conditions

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Type II Diabetes Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Metformin/Atorvastatin

Metformin/Atorvastatin, QD

Group Type ACTIVE_COMPARATOR

Metformin/Atorvastatin 1500mg/40mg, QD

Intervention Type DRUG

Metformin

Metformin, QD

Group Type PLACEBO_COMPARATOR

Atorvastatin 40mg, QD

Intervention Type DRUG

Atorvastatin

Atorvastatin, QD

Group Type PLACEBO_COMPARATOR

Metformin 1500mg, QD

Intervention Type DRUG

Interventions

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Metformin/Atorvastatin 1500mg/40mg, QD

Intervention Type DRUG

Metformin 1500mg, QD

Intervention Type DRUG

Atorvastatin 40mg, QD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with Dyslipidemia and Type II Diabetes
* 19 years later, men and women under the age of 80

Exclusion Criteria

* Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
* Subject with type I Diabetes
* Subject with hypertension which does not controlled by treatment(have blood pressure \> 180/110mmHg)
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_MA001

Identifier Type: -

Identifier Source: org_study_id

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