Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin
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| ClinicalTrials.gov Identifier: NCT03076112 |
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Recruitment Status :
Recruiting
First Posted : March 9, 2017
Last Update Posted : October 8, 2019
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Sponsor:
Seoul National University Bundang Hospital
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital
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Brief Summary:
The objectives of this study are 1) to compare the effect of ipragliflozin 50 mg on glucose-lowering effect with sitagliptin 100 mg in patients with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin, 2) to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers, 3) to examine changes of body composition including fat and muscle mass with volume status.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: Ipragliflozin Drug: Sitagliptin | Phase 3 |
The objectives of this study are to compare the effect of 50mg of ipragliflozin, a SGLT2 inhibitor, on glucose-lowering effect with 100mg of sitagliptin, a DPP4 inhibitor in patients with type 2 diabetes mellitus, whose HbA1c level is ≥ 7.5% with sulfonylurea and metformin.
We are also going to investigate changes of other metabolic and cardiovascular risk factors such as triglyceride, HDL-cholesterol, uric acid, blood pressure, and inflammatory markers.
Changes of body composition including fat and muscle mass with volume status will be also examined.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 170 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin |
| Actual Study Start Date : | April 25, 2017 |
| Estimated Primary Completion Date : | December 1, 2020 |
| Estimated Study Completion Date : | December 30, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ipragliflozin
Ipragliflozin 50 mg in addition to their preexisting sulfonylurea and metformin ** Metformin and sulfonylurea's dosages
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Drug: Ipragliflozin
Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
Other Name: Suglat |
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Active Comparator: Sitagliptin
Sitagliptin 100 mg in addition to their preexisting sulfonylurea and metformin ** Metformin and sulfonylurea's dosages
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Drug: Sitagliptin
Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
Other Name: Januvia |
Primary Outcome Measures :
- Glycated hemoglobin [ Time Frame: Baseline, week 12, week 24 ]Change of HbA1c after 24 weeks' treatment
Secondary Outcome Measures :
- Glycemic target goal achievement [ Time Frame: Baseline, week 12, week 24 ]Glycemic target goal achievement (HbA1c < 7%) at week 24
- Body weight [ Time Frame: Baseline, week 12, week 24 ]Change of body weight at week 24
- Body fat mass [ Time Frame: Baseline, week 24 ]Change of body fat mass at week 24
- Fasting plasma glucose level [ Time Frame: Baseline, week 12, week 24 ]Change of fasting plasma glucose level at week 24
- Postprandial 2hr glucose level [ Time Frame: Baseline, week 12, week 24 ]Changes of postprandial 2hr glucose level at week 24
- Blood Pressure [ Time Frame: Baseline, week 12, week 24 ]Change of systolic/diastolic blood pressure at week 24
- Triglyceride/HDL-cholesterol ratio [ Time Frame: Baseline, week 12, week 24 ]Changes of triglyceride/HDL-cholesterol ratio at week 24
- Uric acid [ Time Frame: Baseline, week 12, week 24 ]Changes of uric acid at week 24
- Parathyroid hormone [ Time Frame: Baseline, week 12, week 24 ]Changes of parathyroid hormone at week 24
- 25-hydroxyvitamin D [ Time Frame: Baseline, week 12, week 24 ]Changes of 25-hydroxyvitamin D at week 24
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| Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes with HbA1c 7.5% - 9.0% at screening visit
- Male or female between 20 and 75 years of age
- Patients taking sulfonylurea (glimepiride 1~8mg or gliclazide 30~120 mg or equivalent dose) and metformin (≥ 1000 mg or maximum tolerated dose) for more than 3 months
- BMI ≥23 kg/m²
- Estimated GFR ≥ 60 ml/min/1.73m²
- Women of child bearing potential must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose and must have a negative urinary pregnancy test.
Exclusion Criteria:
- Type 1 diabetes, gestational diabetes, or diabetes with secondary cause
- Patients with acute coronary syndrome within 3 months prior to screening visit
- Patients with acute coronary syndrome within 3 months prior to screening visit
- Pregnant or breastfeeding women or reproductive-age women who refuse contraception
- Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT > 3-fold the upper limit of normal)
- Cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
- Other clinical trials within 30 days
- Alcohol abuse
- Contraindication to SGLT2 inhibitors or Dipeptidyl-peptidase 4 inhibitors
- Taking insulin, oral hypoglycemic agents other than metformin, sulfonylurea, and the study drugs.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076112
Contacts
| Contact: Jie-Eun Lee, MD | +82-10-7178-1569 | orangerie@gmail.com | |
| Contact: Soo Lim, MD, PhD | +82-31-787-7035 | limsoo@snu.ac.kr |
Locations
| Korea, Republic of | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam, Gyeonggi, Korea, Republic of, 463-707 | |
| Contact: Soo Lim, MD, PHD 82-31-787-7035 limsoo@snu.ac.kr | |
| Contact: Kyoung Min Kim, MD, PHD 82-31-787-7047 kyoungmin02@gmail.com | |
| Principal Investigator: Soo Lim, MD, PHD | |
Sponsors and Collaborators
Seoul National University Bundang Hospital
Astellas Pharma Korea, Inc.
Investigators
| Principal Investigator: | Soo Lim | Seoul National University Bundang Hospital |
Publications:
| Responsible Party: | Soo Lim, Associate Professor, Seoul National University Bundang Hospital |
| ClinicalTrials.gov Identifier: | NCT03076112 History of Changes |
| Other Study ID Numbers: |
B-1612/375-004 |
| First Posted: | March 9, 2017 Key Record Dates |
| Last Update Posted: | October 8, 2019 |
| Last Verified: | October 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Soo Lim, Seoul National University Bundang Hospital:
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Ipragliflozin Sitagliptin |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Sitagliptin Phosphate Ipragliflozin Hypoglycemic Agents |
Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Sodium-Glucose Transporter 2 Inhibitors |