Clinical trial NCT01037842: Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Official title: Phase 3 Study of Combination of Mitiglinide and Metformin in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
name: The Catholic University of Korea
name: Uijeongbu St. Mary Hospital
name: Korea University
name: Kyungpook National University Hospital
name: Pusan National University College of Medicine
name: Sungkyunkwan University
name: Yonsei University
name: Eulji University
name: Chonnam National University
name: Chonbuk National University
name: Chungnam National University
name: Hallym University
First posted: 2009-12-23
Enrollment: 145
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the change in HbA1c from randomization to endpoint
timeFrame: 16 weeks after radomization
Secondary outcomes:
measure: 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
timeFrame: 16 weeks after radomization
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University College of Medicine
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University School of Medicine
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University College of Medicine
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University College of Medicine
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Eulji University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Hallym University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Korea University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: SungKyunKwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary Hospital
Study officials:
References: