Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106131
• Other study ID #: 19DM09F
• Status: Completed
• Phase: Phase 3
• First received: April 16, 2010
• Last updated: February 13, 2013
• Start date: May 2010
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.

Description:

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 and metformin combination for 24 weeks in type 2 diabetes mellitus. Furthermore, the extension study for additional 28weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: November 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Between 18 years and 80 years old(male or female)

• Type ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• CKD-501 0.5mg
CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.
• Pioglitazone 15mg
Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Glycosylated Hemoglobin (HbA1c)		Baseline, 24 weeks	No
Secondary	Change from baseline in glycemic parameters		Baseline, 24 weeks	No
Secondary	Change from baseline in HbA1c target achievement rate (HbA1c < 7%)		Baseline, 24 weeks	No
Secondary	Change from baseline in lipid parameters		Baseline, 24 weeks	No
Secondary	Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse events		Baseline, 24 weeks	Yes