ClinicalTrials.Veeva

Menu

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

Seoul National University logo

Seoul National University

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: Mitiglinide
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01037842
IMMEDIATE

Details and patient eligibility

About

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).

Full 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.

Enrollment

145 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

145 participants in 2 patient groups, including a placebo group

Metformin+Mitiglinide
Active Comparator group
Description:
mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
Treatment:
Drug: Mitiglinide
Metformin+Placebo
Placebo Comparator group
Description:
placebo three times a day added to metformin 500 mg three times a day
Treatment:
Drug: Placebo

Trial contacts and locations

13

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems