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Type2diabetesPhase 4KLIMTNCT06875193

DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes

A Phase 4 study testing DW6012(Dasidiem tab. 10/100mg) in people with Type2diabetes, run by Dong Wha Pharmaceutical Co. Ltd. at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Key finding of DM Treatment with combination, A MuLticenter, Randomized, Parallel, Gathering Information of phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone add-on to Metformin and DPP-4 inhibitor in Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type2diabetes
What is being tested?
DW6012(Dasidiem tab. 10/100mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteSouth Korea
Study dates
28 May 2024to 31 Dec 2025
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes who are 19 years of age or older at the date of written consent
  • Subjects who Receiving a stable dose of metformin and a DPP-4 inhibitor for at least the last 8 weeks at the time of screening
  • HbA1c ≤ 7.0% ≤ HbA1c < 10% at time of screening
  • BMI ≤ 18.5 kg/m2 ≤ 40 kg/m2 at time of screening
  • Subjects fully explained and understood the purpose and methods of this study and voluntarily gave written informed consent

Who cannot join

  • Patients with type 1 diabetes
  • Have a BMI > 40 kg/m2
  • Subjects who have moderate (Stage 3b) or severe kidney disease or an estimated glomerular filtration rate (eGFR, using the CKD-EPI formula) < 45 mL/min/1.73 m2
  • Patients with end stage renal disease or patients on dialysis
  • Patients with uncontrolled heart failure (NYHA class III - IV)
  • Patients with history of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, cerebrovascular disease within 24 weeks prior to the screening visit
Show all 24Show fewer
  • Patients with acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and patients with a history of ketoacidosis
  • Patients with diabetic coma or precoma
  • Patients with a history of severe hypoglycemia while taking metformin and DPP-4 inhibitors.
  • Patients with hematuria
  • Patients who receiving treatment for thyroid dysfunction at the time of screening
  • Malnourished, starving, or debilitated subjects
  • Patients with pituitary insufficiency or adrenal insufficiency
  • Patients with clinically significant hepatic disease with AST or ALT greater than 3 times the upper limit of normal
  • Patients with severe infectious diseases, perioperative, or clinically significant trauma
  • Have a history of substance abuse
  • Patients receiving insulin or sulfonylurea, thiazolidinedione, SGLT2 inhibitor, GLP-1 receptor agonist within 8 weeks prior to the screening visit
  • Patients who have received more than 2 consecutive weeks of corticosteroids within 8 weeks at the time of screening or who require treatment requiring repeated use of corticosteroids
  • Patients with a history of malignancy within the last 5 years
  • Participation in any other clinical trial within 12 weeks of screening in which an investigational drug or investigational medical device was administered or applied
  • Pregnant and breastfeeding women
  • Hypersensitivity to any of the drugs and components, including metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea class of drugs, or any of the ingredients
  • Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose mal-absorption.
  • Any other person deemed by the investigator to be unsuitable for participation in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul

    Kyung Hee University Hospital at Gangdong, 82+2-440-7000, cri@khnmc.or.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Key Finding of DM Treatment with Combination, a MuLticenter, Randomized, Parallel, Gathering Information of Phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone Add-on to Metformin and DPP-4 Inhibitor in Patients with Type 2 Diabetes

Key finding of DM Treatment with combination, A MuLticenter, Randomized, Parallel, Gathering Information of phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone add-on to Metformin and DPP-4 inhibitor in Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and DPP-4 inhibitor(KLIMT Study)

Read the detailed description

This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial

Conditions
Type2diabetes
Being tested
DW6012(Dasidiem tab. 10/100mg)
Keywords
Dapagliflozin, Pioglitazone, DPP-4 inhibitor

What participants receive

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

  • DW6012(Dasidiem tab. 10/100mg)Drug

    Also called Piotazone tab., Sitdiem tab. 100mg

    Once a day, Oral administration

Study groups in NCT06875193
Study groupRoleWhat they receive
Dasidiem 10/100mgExperimentalDapagliflozin 10mg +sitagliptin 100mg combination drug
Receives: Drug: DW6012(Dasidiem tab. 10/100mg)
sitdiem 100mg, Piotazone15mgActive comparatorsitagliptin 100mg, Pioglitazone 15mg
Receives: Drug: DW6012(Dasidiem tab. 10/100mg)

What is being measured

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

  1. Variance in HbA1c from baseline to 24 weeks on study drug

    Change in HbA1c

    Measured: 24 weeks

Secondary outcomes (14)

  1. Variance in HbA1c from baseline to 12 weeks on study drug

    Change in HbA1c

    Measured: 12 weeks

  2. Variance in FPG from baseline to 12, 24 weeks on study drug

    Change in Fasting Plasma Glucose(FPG)

    Measured: 12, 24 weeks

  3. Variance in TC(mg/dL), TG(mg/dL), HDL(mg/dL), LDL(mg/dL) from baseline to 12, 24 weeks on study drug

    Change in TC, TG, HDL, LDL

    Measured: 12, 24 weeks

  4. Variance in FLI(Fatty Liver Index), AST, ALT, r-GTP, ALP, HSI(Hepatic steatosis index), Total bilirubin, Albumin, Protein from baseline to 12 and 24 weeks after study drug administration

    FLI(Fatty Liver Index)= 1/(1+exp(-x))×100

    HSI(Hepatic steatosis index) = 8×ALT/AST+BMI(+2, if type 2 diabetes yes, +2 if female)

    Measured: 12, 24 weeks

  5. Variance in Kidney value from baseline to 12, 24 weeks on study drug

    Kidney value: eGFR(CKD-EPI fomulation) ACR(Albumin to Creatine ratio), Creatinine

    Measured: 12, 24 weeks

  6. Variance in body weight from baseline to 12, 24 weeks on study drug

    Measured: 12, 24 weeks

  7. Percentage of patients achieving HbA1c of 7.0% or 6.5% or less at 12 and 24 weeks post study drug administration compared to baseline

    Percentage of patients achieving HbA1c of 7.0% or 6.5% or less

    Measured: 12, 24 weeks

  8. Variance in Insulin from baseline to 12, 24 weeks on study drug

    Measured: 12, 24 weeks

  9. Percentage of subjects prescribed an rescue drug during this study

    rescue drug

    Measured: during 24weeks(study duration/per subject)

  10. Variance in waist measurement from baseline to 12, 24 weeks on study drug

    Measured: 12, 24 weeks

  11. Variance in BMI from baseline to 12, 24 weeks on study drug

    Measured: 12, 24 weeks

  12. Variance in blood pressure from baseline to 12, 24 weeks on study drug

    Measured: 12, 24 weeks

  13. Variance in HOMA-IR, HOMA-β(Glucose in Molar Units mmol/L) from baseline to 12, 24 weeks on study drug

    Measured: 12, 24 weeks

  14. Variance in c-peptide from baseline to 12, 24 weeks on study drug

    Measured: 12, 24 weeks

Timeline

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

  1. First posted13 Mar 2025
  2. Study start28 May 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

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 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06875193
Sponsor's protocol ID
DW6012-IV-2
Acronym
KLIMT
Status last verified
Mar 2025
First submitted
24 Feb 2025
Last updated
17 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DW6012(Dasidiem tab. 10/100mg) in people with Type2diabetes, run by Dong Wha Pharmaceutical Co. Ltd. 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 5 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variance in HbA1c from baseline to 24 weeks on study drug (time frame: 24 weeks). 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 NCT06875193.

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 17 Mar 2025.

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