AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3NCT03076112

Efficacy of Ipragliflozin Compared With Sitagliptin in Uncontrolled Type 2 Diabetes With Sulfonylurea and Metformin

A Phase 3 study testing Ipragliflozin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Ipragliflozin and Sitagliptin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteSouth Korea
Study dates
25 Apr 2017to 31 Aug 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

Other trials in South Korea

About this study

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.

Read the detailed description

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.

Being tested
Ipragliflozin, Sitagliptin
Keywords
Ipragliflozin, Sitagliptin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpragliflozinDrug

    Also called Suglat

    Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes

  • SitagliptinDrug

    Also called Januvia

    Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes

Study groups in NCT03076112
Study groupRoleWhat they receive
IpragliflozinExperimentalIpragliflozin 50 mg in addition to their preexisting sulfonylurea and metformin ** Metformin and sulfonylurea's dosages * Metformin 500 mg - 2550 mg * Sulfonylurea: Glimepiride 1 mg - 8 mg or Gliclazide MR 30 mg - 120 mg
Receives: Drug: Ipragliflozin
SitagliptinActive comparatorSitagliptin 100 mg in addition to their preexisting sulfonylurea and metformin ** Metformin and sulfonylurea's dosages * Metformin 500 mg - 2550 mg * Sulfonylurea: Glimepiride 1 mg - 8 mg or Gliclazide MR 30 mg - 120 mg
Receives: Drug: Sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated hemoglobin

    Change of HbA1c after 24 weeks' treatment

    Measured: Baseline, week 12, week 24

Secondary outcomes (10)

  1. Glycemic target goal achievement

    Glycemic target goal achievement (HbA1c < 7%) at week 24

    Measured: Baseline, week 12, week 24

  2. Body weight

    Change of body weight at week 24

    Measured: Baseline, week 12, week 24

  3. Body fat mass

    Change of body fat mass at week 24

    Measured: Baseline, week 24

  4. Fasting plasma glucose level

    Change of fasting plasma glucose level at week 24

    Measured: Baseline, week 12, week 24

  5. Postprandial 2hr glucose level

    Changes of postprandial 2hr glucose level at week 24

    Measured: Baseline, week 12, week 24

  6. Blood Pressure

    Change of systolic/diastolic blood pressure at week 24

    Measured: Baseline, week 12, week 24

  7. Triglyceride/HDL-cholesterol ratio

    Changes of triglyceride/HDL-cholesterol ratio at week 24

    Measured: Baseline, week 12, week 24

  8. Uric acid

    Changes of uric acid at week 24

    Measured: Baseline, week 12, week 24

  9. Parathyroid hormone

    Changes of parathyroid hormone at week 24

    Measured: Baseline, week 12, week 24

  10. 25-hydroxyvitamin D

    Changes of 25-hydroxyvitamin D at week 24

    Measured: Baseline, week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2017
  2. Study start25 Apr 2017
  3. Primary completion30 Jun 2022
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03076112
Sponsor's protocol ID
B-1612/375-004
Status last verified
Oct 2022
First submitted
6 Mar 2017
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Yes

Publications

  • Hedrington MS, Davis SN. Ipragliflozin , a sodium-glucose cotransporter 2 inhibitor, in the treatment of type 2 diabetes. Expert Opin Drug Metab Toxicol. 2015 Apr;11(4):613-23. doi: 10.1517/17425255.2015.1009893. Epub 2015 Feb 2.

    PubMed 25643044

  • Kadokura T, Zhang W, Krauwinkel W, Leeflang S, Keirns J, Taniuchi Y, Nakajo I, Smulders R. Clinical pharmacokinetics and pharmacodynamics of the novel SGLT2 inhibitor ipragliflozin. Clin Pharmacokinet. 2014 Nov;53(11):975-88. doi: 10.1007/s40262-014-0180-z.

    PubMed 25316572

  • Veltkamp SA, van Dijk J, Collins C, van Bruijnsvoort M, Kadokura T, Smulders RA. Combination treatment with ipragliflozin and metformin: a randomized, double-blind, placebo-controlled study in patients with type 2 diabetes mellitus. Clin Ther. 2012 Aug;34(8):1761-71. doi: 10.1016/j.clinthera.2012.06.027. Epub 2012 Jul 15.

    PubMed 22795925

  • Takasu T, Hayashizaki Y, Tahara A, Kurosaki E, Takakura S. Antihyperglycemic effect of ipragliflozin, a sodium-glucose co-transporter 2 inhibitor, in combination with oral antidiabetic drugs in mice. Clin Exp Pharmacol Physiol. 2015 Jan;42(1):87-93. doi: 10.1111/1440-1681.12317.

    PubMed 25311502

  • Smulders RA, Zhang W, Veltkamp SA, van Dijk J, Krauwinkel WJ, Keirns J, Kadokura T. No pharmacokinetic interaction between ipragliflozin and sitagliptin, pioglitazone, or glimepiride in healthy subjects. Diabetes Obes Metab. 2012 Oct;14(10):937-43. doi: 10.1111/j.1463-1326.2012.01624.x. Epub 2012 Jun 7.

    PubMed 22587345

  • Macdonald FR, Peel JE, Jones HB, Mayers RM, Westgate L, Whaley JM, Poucher SM. The novel sodium glucose transporter 2 inhibitor dapagliflozin sustains pancreatic function and preserves islet morphology in obese, diabetic rats. Diabetes Obes Metab. 2010 Nov;12(11):1004-12. doi: 10.1111/j.1463-1326.2010.01291.x.

    PubMed 20880347

  • Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29.

    PubMed 23906445

  • Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15.

    PubMed 25592197

  • Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. doi: 10.1111/j.1463-1326.2007.00744.x. Epub 2007 Jun 26.

    PubMed 17593236

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ipragliflozin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Seoul National University Bundang Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycated hemoglobin (time frame: Baseline, week 12, week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03076112, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in