Back to resultsDurable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Imeglimin
Metformin
Vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent.
- Patients being treated with diet and exercise therapy only at the time of eligibility test However, if the patient is taking one oral hypoglycemic drug at the time of obtaining consent, the patient must be able to wash out the oral hypoglycemic drug for at least 12 weeks before the start of study treatment.
- Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test.
- Patients who have given written consent to participate in this study.
Exclusion Criteria:
When consent is obtained
- Patients with type 1 diabetes mellitus
- Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks
- Patients who have received glucagon like peptide-1 receptor agonist (short-term use of insulin for trauma or educational admission) within 1 year or less
- Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy)
- Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life)
- Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin
- Patients with severe obesity (BMI 35 kg/m^2 or more)
- Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation
- Excessive regular drinkers
- Patients with a previous history of lactic acidosis
- Patients with severe cachexia, diabetic coma or precoma
- Patients with severe infections, surgical patients and those with serious injuries
- Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding
- Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years
- Patients who are participating in a clinical study with other interventions
- Patients to whom a responsible physician/investigator judged inappropriate for participating in the study In case of eligibility testing
- Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73m^2 or less including those undergoing dialysis
- Patients with severe hepatic disorders (Child-Pugh classification Grade C)
Sites / Locations
- Center Hospital of the National Center for Global Health and MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Imeglimin
Metformin
Vildagliptin
Arm Description
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
Metformin 500 mg orally twice daily in the morning and evening (1000 mg daily). However, until 2 weeks after the start of treatment, 250 mg should be administered orally twice daily in the morning and evening. Thereafter, after 4, 8, or 12 weeks, the dose may be increased up to 750 mg twice daily (1500 mg daily) if the physician determines that the hypoglycemic effect is inadequate.
Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).
Outcomes
Primary Outcome Measures
Time from study drug initiation (Week 0) to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16.
Secondary Outcome Measures
Time from Week 0 to addition of a type 2 diabetes mellitus medication after Week 16
Time from detection of two consecutive HbA1c levels of 7.0% or higher to addition of a type 2 diabetes mellitus medication after Week 16.
HbA1c level, fasting blood glucose level, and their changes from baseline at each measurement point
Maximum decrease in HbA1c level during the observation period
Proportion of patients achieving HbA1c level less than 7.0% at each measurement point
Number of times of achieving HbA1c level less than 7.0% during the observation period
Time from Week 0 to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16 by patient characteristics
Full Information
NCT ID
NCT05366868
First Posted
April 15, 2022
Last Updated
September 26, 2022
Sponsor
National Center for Global Health and Medicine, Japan
Collaborators
Sumitomo Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05366868
Brief Title
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
Official Title
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Center for Global Health and Medicine, Japan
Collaborators
Sumitomo Pharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study subjects will be randomly assigned to the three groups and receive the study drug for maximum of 156 weeks and undergo blood samplings and other diabetes mellitus-related tests. The aim of the present study is to evaluate the durability of glycemic control over 3 years for patients with type 2 diabetes on diet and exercise therapy treated with oral hypoglycemic drug monotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
567 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imeglimin
Arm Type
Experimental
Arm Description
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
Metformin 500 mg orally twice daily in the morning and evening (1000 mg daily). However, until 2 weeks after the start of treatment, 250 mg should be administered orally twice daily in the morning and evening. Thereafter, after 4, 8, or 12 weeks, the dose may be increased up to 750 mg twice daily (1500 mg daily) if the physician determines that the hypoglycemic effect is inadequate.
Arm Title
Vildagliptin
Arm Type
Active Comparator
Arm Description
Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).
Intervention Type
Drug
Intervention Name(s)
Imeglimin
Intervention Description
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 500 mg orally twice daily in the morning and evening (1000 mg daily). However, until 2 weeks after the start of treatment, 250 mg should be administered orally twice daily in the morning and evening. Thereafter, after 4, 8, or 12 weeks, the dose may be increased up to 750 mg twice daily (1500 mg daily) if the physician determines that the hypoglycemic effect is inadequate.
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Intervention Description
Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).
Primary Outcome Measure Information:
Title
Time from study drug initiation (Week 0) to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16.
Time Frame
From 16 to 156 weeks after the start of study drug administration
Secondary Outcome Measure Information:
Title
Time from Week 0 to addition of a type 2 diabetes mellitus medication after Week 16
Time Frame
From 16 to 156 weeks after the start of study drug administration
Title
Time from detection of two consecutive HbA1c levels of 7.0% or higher to addition of a type 2 diabetes mellitus medication after Week 16.
Time Frame
From 16 to 156 weeks after the start of study drug administration
Title
HbA1c level, fasting blood glucose level, and their changes from baseline at each measurement point
Time Frame
From 0 to 156 weeks after the start of study drug administration
Title
Maximum decrease in HbA1c level during the observation period
Time Frame
From 0 to 156 weeks after the start of study drug administration
Title
Proportion of patients achieving HbA1c level less than 7.0% at each measurement point
Time Frame
From 0 to 156 weeks after the start of study drug administration
Title
Number of times of achieving HbA1c level less than 7.0% during the observation period
Time Frame
From 0 to 156 weeks after the start of study drug administration
Title
Time from Week 0 to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16 by patient characteristics
Time Frame
From 0 to 156 weeks after the start of study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent.
Patients being treated with diet and exercise therapy only at the time of eligibility test However, if the patient is taking one oral hypoglycemic drug at the time of obtaining consent, the patient must be able to wash out the oral hypoglycemic drug for at least 12 weeks before the start of study treatment.
Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test.
Patients who have given written consent to participate in this study.
Exclusion Criteria:
When consent is obtained
Patients with type 1 diabetes mellitus
Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks
Patients who have received glucagon like peptide-1 receptor agonist (short-term use of insulin for trauma or educational admission) within 1 year or less
Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy)
Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life)
Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin
Patients with severe obesity (BMI 35 kg/m^2 or more)
Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation
Excessive regular drinkers
Patients with a previous history of lactic acidosis
Patients with severe cachexia, diabetic coma or precoma
Patients with severe infections, surgical patients and those with serious injuries
Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding
Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years
Patients who are participating in a clinical study with other interventions
Patients to whom a responsible physician/investigator judged inappropriate for participating in the study In case of eligibility testing
Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73m^2 or less including those undergoing dialysis
Patients with severe hepatic disorders (Child-Pugh classification Grade C)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kohjiro Ueki, M.D., Ph.D.
Phone
+813-5273-5355
Email
uekik@ri.ncgm.go.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Ryotaro Bouchi, M.D., Ph.D.
Phone
+813-3202-7181
Email
rybouchi@hosp.ncgm.go.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kohjiro Ueki, M.D., Ph.D.
Organizational Affiliation
Center Hospital of the National Center for Global Health and Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kohjiro Ueki, M.D., Ph.D.
Phone
+813-5273-5355
Email
uekik@ri.ncgm.go.jp
First Name & Middle Initial & Last Name & Degree
Ryotaro Bouchi, M.D., Ph.D.
Phone
+813-3202-7181
Email
rybouchi@hosp.ncgm.go.jp
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
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