Trial | NCT01037842  Report issue

Title

Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Phase 3 Study of Combination of Mitiglinide and Metformin in Patients With Type 2 Diabetes Mellitus

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mitiglinide ...

  • Study Participants

    145
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).
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.
Study Started
Aug 31
2006
Primary Completion
Mar 31
2008
Study Completion
May 31
2008
Last Update
Dec 23
2009
Estimate

Drug Mitiglinide

mitiglinide 10 mg three times a day added to metformin 500 mg three times a day for 16 weeks

Drug Placebo

placebo three times a day added to metformin 500 mg three times a day for 16 weeks

Metformin+Mitiglinide Active Comparator

mitiglinide 10 mg three times a day added to metformin 500 mg three times a day

Metformin+Placebo Placebo Comparator

placebo three times a day added to metformin 500 mg three times a day

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
No Results Posted