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
Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02947620
Collaborator
(none)
180
1
3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date
:
Aug 1, 2015
Anticipated Primary Completion Date
:
Feb 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Metformin/Atorvastatin Metformin/Atorvastatin, QD |
Drug: Metformin/Atorvastatin 1500mg/40mg, QD
|
| Placebo Comparator: Metformin Metformin, QD |
Drug: Atorvastatin 40mg, QD
|
| Placebo Comparator: Atorvastatin Atorvastatin, QD |
Drug: Metformin 1500mg, QD
|
Outcome Measures
Primary Outcome Measures
- Change in HbA1c [Change from baseline at 16 weeks]
- Change in LDL Cholesterol [Change from baseline at 16 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT02947620
Other Study ID Numbers:
- DW_MA001
First Posted:
Oct 28, 2016
Last Update Posted:
Oct 31, 2016
Last Verified:
Oct 1, 2016