Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin
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ClinicalTrials.gov Identifier: NCT01106131 |
Recruitment Status :
Completed
First Posted : April 19, 2010
Last Update Posted : February 15, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: CKD-501 0.5mg Drug: Pioglitazone 15mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 253 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of CKD-501 or Pioglitazone Added to Ongoing Metformin Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Alone: Multi Center, Randomized, Double Blind, Therapeutic Confirmatory Study |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: CKD-501 0.5mg |
Drug: CKD-501 0.5mg
CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.
Other Name: Lobeglitazone |
Active Comparator: Pioglitazone 15mg |
Drug: Pioglitazone 15mg
Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin. |
- Change from baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, 24 weeks ]
- Change from baseline in glycemic parameters [ Time Frame: Baseline, 24 weeks ]
- Change from baseline in HbA1c target achievement rate (HbA1c < 7%) [ Time Frame: Baseline, 24 weeks ]
- Change from baseline in lipid parameters [ Time Frame: Baseline, 24 weeks ]
- Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events [ Time Frame: Baseline, 24 weeks ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Between 18 years and 80 years old(male or female)
- Type Ⅱ diabetes mellitus
- The patient who has been taking oral hypoglycemic agent since 2 months with HbA1c 7 to 10% at screening test
- BMI between 21kg/㎡ and 40kg/㎡
- C-peptide level is over 1.0 ng/ml
- Agreement with written informed consent
Exclusion Criteria:
- Type I diabetes or secondary diabetes
- Continuous or non continuous treatment(over 7 days) insulin within 3 month prior to screening
- Treatment with thiazolidinediones within 60 days or patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
- Chronic(continuous over 7 days) oral or non oral corticosteroids treatment within 1 month prior to screening
- Past history: lactic acidosis or metformin contraindication
- Acute or chronic metabolic acidosis including diabetic ketoacidosis
- History of proliferative diabetic retinopathy
- Severe infection, severe injury patients (pre and post operation)
- Oligotrophy,starvation, hyposthenia, pituitary insufficiency or capsular insufficiency
- Drug abuse or history of alcoholism
- History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
- Fasting Plasma Glucose level is over 270 mg/dl
- Triglyceride level is 500 mg/dl and over
- Significant abnormal liver dysfunction: AST, ALT level over or equal to 2.5 times, Total bilirubin level over or equal 2 times as high as upper normal limit(UNL)
- Significant abnormal renal dysfunction
- Anemia
- Abnormality of thyroid function(out of significant normal TSH range )
- Hepatitis B or C test is positive
- Pregnant women or nursing mothers
- Has a contraindication to treatment
- Fertile women who not practice contraception with appropriate methods
- Participated in other trial within 4 weeks
- Participating in other trial at present
- In investigator's judgment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106131
Korea, Republic of | |
Kangbuk Samsung Hospital | |
Seoul, Korea, Republic of |
Study Chair: | SungWoo Park, M.D., Ph.D. | Kangbuk Samsung Hospital |
Responsible Party: | Chong Kun Dang Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT01106131 |
Other Study ID Numbers: |
19DM09F |
First Posted: | April 19, 2010 Key Record Dates |
Last Update Posted: | February 15, 2013 |
Last Verified: | February 2013 |
Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs |