Recruiting NCT07442006
Glycemic Variability of Combination Therapies in T2DM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin/Metformin, Anagliptin, Metformin, Empagliflozin/Linagliptin.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Study to Evaluate Efficacy and Safety
Overview
Glycemic Variability of Combination Therapies in T2DM
Detailed description
A multicenter study to evaluate efficacy and safety
Interventions
- Drug Empagliflozin/Metformin
5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID) - Drug Anagliptin
100 mg, for 12 weeks (PO, BID) - Drug Metformin
500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID) - Drug Empagliflozin/Linagliptin
10/5 mg, for 12 weeks (PO, QD)
Primary outcome measures
- Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12 [Time frame: Baseline to week 12]
Secondary outcome measures (6)
- Change in the percentage of time spent within the target glucose range (70-180 mg/dL) [Time frame: Baseline to week 12]
- Change from baseline in mean blood glucose at 12 weeks [Time frame: Baseline to week 12]
- Change from baseline in HbA1c at 12 weeks [Time frame: Baseline to week 12]
- Change from baseline in FPG at 12 weeks [Time frame: Baseline to week 12]
- Change from baseline in HOMA-β at 12 weeks [Time frame: Baseline to week 12]
- Change from baseline in HOMA-IR at 12 weeks [Time frame: Baseline to week 12]
Eligibility criteria
Inclusion criteria
- Inadequate glycemic control despite treatment with Metformin (≥ 1,000mg/day) and SGLT-2 inhibitor.
Exclusion criteria
- History of acute or chronic metabolic acidosis
- Moderate to severe renal impairment (eGFR < 45 mL/min/1.73m²)
- Severe hepatic impairment
- History of heart failure (NYHA Class III/IV)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator — Seoul
Identifiers
NCT: NCT07442006 · JW25402