Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)
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
1 other identifier
interventional
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 26, 2016
CompletedFirst Posted
Study publicly available on registry
October 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedJune 18, 2023
October 1, 2016
1.6 years
October 26, 2016
June 15, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 from baseline at 16 weeks
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
Change from baseline at 16 weeks
Secondary Outcomes (9)
Change in LDL-C
Baseline and 16 weeks
Change in HbA1c
Baseline and 16 weeks
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
16 weeks
Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products
16 weeks
Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline
Baseline, 4 weeks, 8 weeks and 12 weeks
- +4 more secondary outcomes
Study Arms (3)
Metformin/Atorvastatin
ACTIVE COMPARATORMetformin/Atorvastatin, QD
Metformin
PLACEBO COMPARATORMetformin, QD
Atorvastatin
PLACEBO COMPARATORAtorvastatin, QD
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with Dyslipidemia and Type II Diabetes
- years later, men and women under the age of 80
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2016
First Posted
October 28, 2016
Study Start
August 1, 2015
Primary Completion
February 27, 2017
Study Completion
February 27, 2017
Last Updated
June 18, 2023
Record last verified: 2016-10