search
Back to results

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

Primary Purpose

Type II Diabetes, Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin/Atorvastatin 1500mg/40mg, QD
Metformin 1500mg, QD
Atorvastatin 40mg, QD
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Metformin/Atorvastatin

Metformin

Atorvastatin

Arm Description

Metformin/Atorvastatin, QD

Metformin, QD

Atorvastatin, QD

Outcomes

Primary Outcome Measures

Change in HbA1c
Change in HbA1c after 16 weeks, relative to baseline, between the combination of Metformin 1500 mg and Atorvastatin 40 mg compared to Atorvastatin 40 mg alone
Change in LDL Cholesterol
Change in low-density lipoprotein cholesterol (LDL-C) after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg

Secondary Outcome Measures

Change in LDL-C
Change in LDL-C after 16 weeks, relative to baseline, between Atorvastatin 40 mg and the combination of Metformin 1500 mg and Atorvastatin 40 mg
Change in HbA1c
Change in HbA1c after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg
Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products
Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products
Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline
Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products
Change in lipid variables and the associated rate of change
Change in lipid variables (HDL-C, TG, TC, non-HDL cholesterol, Apolipoprotein A1, Apolipoprotein B) and the associated rate of change after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline
Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline
Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.

Full Information

First Posted
October 26, 2016
Last Updated
June 15, 2023
Sponsor
Daewoong Pharmaceutical Co. LTD.
search

1. Study Identification

Unique Protocol Identification Number
NCT02947620
Brief Title
Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)
Official Title
A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 27, 2017 (Actual)
Study Completion Date
February 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin/Atorvastatin
Arm Type
Active Comparator
Arm Description
Metformin/Atorvastatin, QD
Arm Title
Metformin
Arm Type
Placebo Comparator
Arm Description
Metformin, QD
Arm Title
Atorvastatin
Arm Type
Placebo Comparator
Arm Description
Atorvastatin, QD
Intervention Type
Drug
Intervention Name(s)
Metformin/Atorvastatin 1500mg/40mg, QD
Intervention Type
Drug
Intervention Name(s)
Metformin 1500mg, QD
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40mg, QD
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change in HbA1c after 16 weeks, relative to baseline, between the combination of Metformin 1500 mg and Atorvastatin 40 mg compared to Atorvastatin 40 mg alone
Time Frame
Change from baseline at 16 weeks
Title
Change in LDL Cholesterol
Description
Change in low-density lipoprotein cholesterol (LDL-C) after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg
Time Frame
Change from baseline at 16 weeks
Secondary Outcome Measure Information:
Title
Change in LDL-C
Description
Change in LDL-C after 16 weeks, relative to baseline, between Atorvastatin 40 mg and the combination of Metformin 1500 mg and Atorvastatin 40 mg
Time Frame
Baseline and 16 weeks
Title
Change in HbA1c
Description
Change in HbA1c after 16 weeks, relative to baseline, between Metformin 1500 mg alone and the combination of Metformin 1500 mg and Atorvastatin 40 mg
Time Frame
Baseline and 16 weeks
Title
Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products
Time Frame
16 weeks
Title
Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products
Time Frame
16 weeks
Title
Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline
Time Frame
Baseline, 4 weeks, 8 weeks and 12 weeks
Title
Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products
Time Frame
Baseline and 16 weeks
Title
Change in lipid variables and the associated rate of change
Description
Change in lipid variables (HDL-C, TG, TC, non-HDL cholesterol, Apolipoprotein A1, Apolipoprotein B) and the associated rate of change after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline
Time Frame
Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Title
Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline
Time Frame
Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Title
Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.
Time Frame
Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs