Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Phase 3 Study of Combination of Mitiglinide and Metformin in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037842
• Other study ID #: IMMEDIATE
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2009
• Last updated: December 19, 2009
• Start date: August 2006
• Est. completion date: May 2008

Study information

• Verified date: December 2009
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

We performed a prospective, randomized, multicenter trial to assess the efficacy and safety of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c >7.0% after an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus mitiglinide (Met+Mit) or metformin plus placebo (Met).

Description:

This was a 16-week, randomized, double-blind study for comparing metformin plus mitiglinide (Met+Mit) versus metformin plus placebo (Met+Pcb). An 8-week metformin run-in phase (500 mg twice a day for the first 4 weeks and 500 mg three times a day for the following 4 weeks) was followed by a 16-week trial phase (mitiglinide 10 mg or placebo three times a day added to metformin 500 mg three times a day). The subjects with an HbA1c >7.0% at the end of the metformin run-in phase were randomized to a Met+Mit group or a Met+Pcb group of the trial phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: May 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• aged 30-70 years

• had a duration of diabetes of <10 years

• body mass index (BMI) 20-35 kg/m2

• a plasma HbA1c level of 7.5-11% during the previous 4 weeks

Exclusion Criteria:

• subjects who were diagnosed with type 1 diabetes, gestational diabetes, or diabetes with any specific causes

• Subjects who had been treated with nateglinide, repaglinide, metformin (over 1,000 mg/day), or sulfonylurea (over a quarter of the maximum recommended dose) during the previous 8 weeks

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Mitiglinide
mitiglinide 10 mg three times a day added to metformin 500 mg three times a day for 16 weeks
• Placebo
placebo three times a day added to metformin 500 mg three times a day for 16 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University College of Medicine	Busan
Korea, Republic of	Kyungpook National University School of Medicine	Daegu
Korea, Republic of	Chungnam National University College of Medicine	Daejeon
Korea, Republic of	Chonnam National University College of Medicine	Gwangju
Korea, Republic of	Chonbuk National University College of Medicine	Jeonju
Korea, Republic of	Eulji University School of Medicine	Seoul
Korea, Republic of	Hallym University College of Medicine	Seoul
Korea, Republic of	Korea University College of Medicine	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	SungKyunKwan University School of Medicine	Seoul
Korea, Republic of	The Catholic University of Korea	Seoul
Korea, Republic of	Yonsei University College of Medicine	Seoul
Korea, Republic of	Uijeongbu St. Mary Hospital	Uijeongbu

Sponsors (14)

Lead Sponsor	Collaborator
Seoul National University Hospital	Chonbuk National University, Chonnam National University, Chungnam National University, Eulji University, Hallym University, Korea University, Kyungpook National University, Pusan National University College of Medicine, Seoul St. Mary's Hospital, Sungkyunkwan University, The Catholic University of Korea, Uijeongbu St. Mary Hospital, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in HbA1c from randomization to endpoint		16 weeks after radomization	No
Secondary	the proportion of subjects with HbA1c <7% after 16 weeks of treatment and the change in FPG and 2-hr postprandial glucose (PPG) from baseline		16 weeks after radomization	No