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Type 2 Diabetes MellitusPhase 4NCT02512523

Exploratory Study to Compare the Effects of Tenelia® or Januvia® on Glucose Variability in add-on to Metformin (CGMS Study)

A Phase 4 study testing Teneligliptin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Handok Inc. 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
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Trial summary

This is a randomized, double-blind, active control, parallel group, exploratory phase 4 study to compare the effect of teneligliptin versus sitagliptin on glucose variability when added on to metformin in patients with inadequately controlled type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Teneligliptin and Sitagliptin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteSouth Korea
Study dates
27 Aug 2015to 26 Sep 2016
Phase
Phase 4
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is male or female aged above (or equal to) 19 years old at screening, inclusive.
  • Patient was diagnosed with type 2 diabetes mellitus at least 3 months prior to screening according to the diagnostic criteria of KDA for at screening
  • Patient has FPG ≤ 270 mg/dl (15.0 mmol/L) at screening
  • Patient who was treated with Metformin (≥1000 mg/day) for at least 8 weeks prior to screening
  • Patient has HbA1c (6.5%≤HbA1c≤9.0%) at screening
  • Patient has adequate renal and hepatic function at screening as defined by the following clinical chemistry results:
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  • (male) Serum creatinine <1.5 × upper limit of normal (ULN), (female) Serum creatinine <1.4 × upper limit of normal (ULN),
  • Serum alanine aminotransferase <2.5 × ULN
  • Serum aspartate aminotransferase <2.5 × ULN
  • Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (eg, barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study(excluding women who are not of childbearing potential and men who have been sterilized).
  • Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to study entry must agree to use 2 medically accepted methods of contraception as per inclusion criterion 7.
  • Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
  • Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and understand this information, voluntarily signed and dated the written informed consent in compliance with protocol before inclusion in the study

Who cannot join

  • Patients who have hypersensitivity/allergies to main ingredient of sitagliptin/teneligliptin or any of the excipients of Investigational products(eg. Mannitol).
  • Patient with severe ketosis, diabetic coma or pre coma, Type 1 DM
  • Patient is suffering from any disease, including Type 2 diabetes or its complications that, in the opinion of the Investigator, is sufficiently severe to render the subject unfit, or affect the subject's ability, to participate in the study, for example:
  • Macroangiopathy with symptoms of coronary heart disease or peripheral arterial obstructive disease.
  • Microangiopathy with symptoms of (autonomous) neuropathy with any one or more of the following: gastroparesis
  • Symptoms of poor blood glucose control (polyuria, polydipsia or weight loss)
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  • Severe infection, pre or post-operative, severe trauma
  • Patient has a medical history of unstable angina, or heart failure(New York Heart Association class Ⅲ-IV) or any clinically significant ECG abnormalities such as ventricular tachycardia
  • The subject has diastolic blood pressure >100 mmHg and/or systolic blood pressure >180 mmHg at the screening visit
  • Patient who has malignancy at screening or history of any malignancy (except history of no recurrence of malignancy more than 5 years)
  • Female patient whose pregnancy test is negative or who are pregnant, lactating, or are planning to become pregnant during the study
  • Patient is expected to require additional diabetic treatment for his/her Type 2 diabetes or its complications during the study after the screening visit
  • Patient has a history of drug abuse
  • Patient who is under malnutrition, weakness or, in the opinion of the Investigator, patient who drinks on average more than 28 units of alcohol per week (One unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 40 mL of spirits)
  • Patients taking any of the following concomitant medications:
  • Oral anti-diabetic therapy excluding Metformin within 8 weeks of screening
  • Thiazolidinedione class of drugs within 12 weeks of screening
  • GLP-1 analogues/DPP4 inhibitor class of drugs within 12 weeks of screening(but, following patients will be excluded from the study regardless of treatment duration of previous DPP4 inhibitors: patient who has experienced failure of glucose control with treatment of DPP4 inhibitors or patient who is not expected to have additional good effect of glucose control with administration of IP according to the investigator's opinion)
  • Anti-obesity agent within 12 weeks of screening
  • All kinds of insulin administered within 12 weeks of screening
  • Systemic Corticosteroids or intermittent use of high-dose of steroids(inhaler)
  • Any other investigational drug
  • Patients who have participated in a study with an investigational drug within 12 weeks of Screening or who are currently receiving treatment with any other investigational drug in a study.
  • The presence of any other condition including clinical laboratory test results that leads the investigator to conclude that the patient is inappropriate for inclusion in the clinical study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • HANDOK Inc.

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Active Control, Parallel Group, Exploratory Phase IV Study to Compare the Effects of Tenelia® or Januvia® on Glucose Variability in add-on to Metformin in Patients With Inadequately Controlled Type2 Diabetes Mellitus in Metformin Only Treatment

This is a randomized, double-blind, active control, parallel group, exploratory phase 4 study to compare the effect of teneligliptin versus sitagliptin on glucose variability when added on to metformin in patients with inadequately controlled type 2 diabetes mellitus.

Read the detailed description

This study will enroll patients with in adequately controlled type 2 diabetes mellitus who have been on metformin (1,000 mg or above) for 8 weeks at least or longer and randomly add teneliglipin (20 mg/day) or sitagliptin (100 mg/day) for 4 weeks. Continuous glucose monitoring will be checked before and after 4-week administration of teneliglipin or sitagliptin together with mixed meal tolerance test (MMTT). Other efficacy and safety parameters will be also assessed.

Being tested
Teneligliptin, Sitagliptin
Keywords
Type 2 diabetes mellitus, CGMS, Teneligliptin, 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.

Study groups in NCT02512523
Study groupRoleWhat they receive
TeneligliptinExperimentalFilm-coated tablet for oral administration Dosage: 20mg/tablet Frequency and duration: 1 tablet/day for 4 weeks
Receives: Drug: Teneligliptin
SitagliptinActive comparatorFilm-coated tablet for oral administration Dosage: 100mg/tablet Frequency and duration: 1 tablet/day for 4 weeks
Receives: Drug: Sitagliptin

What is being measured

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

  1. Mean amplitude of glucose excursion (MAGE)

    Change in mean amplitude of glucose excursion (MAGE) from baseline at 4 weeks

    Measured: 4 weeks

Secondary outcomes (4)

  1. Standard deviation (SD)

    Change in standard deviation (SD) from baseline at 4 weeks

    Measured: 4 weeks

  2. Mean blood glucose (MBG)

    Change in mean blood glucose (MBG) from baseline at 4 weeks

    Measured: 4 weeks

  3. Mixed meal tolerance test (MMTT)

    Change in Mixed meal tolerance test (MMTT) parameters including glucose, GLP-1, insulin, C-peptide, glucagon, HOMA-IR, HOMA-b from baseline at 4 weeks

    Measured: 4 weeks

  4. Safety (All AE including SAE, hypoglycemia, laboratory tests, vital sign, and physical examination)

    All AE including SAE, hypoglycemia, laboratory tests, vital sign, and physical examination

    Measured: 4 weeks

Timeline

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

  1. First posted31 Jul 2015 (estimated)
  2. Study start27 Aug 2015
  3. Primary completion26 Sep 2016
  4. Study completion26 Sep 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02512523
Sponsor's protocol ID
HD_TEN_PH42014
Status last verified
Jan 2025
First submitted
29 Jul 2015
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Teneligliptin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Handok Inc. 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 13 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: finished, as of the sponsor's last update on 27 Jan 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?

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?

Mean amplitude of glucose excursion (MAGE) (time frame: 4 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 NCT02512523.

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 27 Jan 2025.

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