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

COMPLETEDPHASE4

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

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

NCT02512523•Handok Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient is male or female aged above (or equal to) 19 years old at screening, inclusive.
•2. 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
•3. Patient has FPG ≤ 270 mg/dl (15.0 mmol/L) at screening
•4. Patient who was treated with Metformin (≥1000 mg/day) for at least 8 weeks prior to screening
•5. Patient has HbA1c (6.5%≤HbA1c≤9.0%) at screening
•6. Patient has adequate renal and hepatic function at screening as defined by the following clinical chemistry results:
•* (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
•7. 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).
+3 more criteria

Exclusion Criteria

•1. Patients who have hypersensitivity/allergies to main ingredient of sitagliptin/teneligliptin or any of the excipients of Investigational products(eg. Mannitol).
•2. Patient with severe ketosis, diabetic coma or pre coma, Type 1 DM
•3. 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)
•* Severe infection, pre or post-operative, severe trauma
•4. 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
•5. The subject has diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg at the screening visit
•6. Patient who has malignancy at screening or history of any malignancy (except history of no recurrence of malignancy more than 5 years)
+14 more criteria

Locations (1)

HANDOK Inc.

Seoul, South Korea

Key Dates

Start Date

August 27, 2015

Primary Completion Date

September 26, 2016

Completion Date

September 26, 2016

Last Updated

January 27, 2025

Enrollment

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus

Interventions

Teneligliptin

DRUG

Sitagliptin

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Achieving Routine Intervention and Screening for Emotional Health

NCT06887049

Type 2 Diabetes Mellitus (T2DM)Diabetes Distress

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Achieving Routine Intervention and Screening for Emotional Health

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