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

NCT02512523 | Completed Phase 4

• 1 other identifier: HD_TEN_PH42014
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; CGMS; Teneligliptin; Sitagliptin

Outcome Measures

Primary Outcomes (1)

• Mean amplitude of glucose excursion (MAGE)

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

  4 weeks

Secondary Outcomes (4)

• Standard deviation (SD)

  4 weeks

• Mean blood glucose (MBG)

  4 weeks

• Mixed meal tolerance test (MMTT)

  4 weeks

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

  4 weeks

Study Arms (2)

Teneligliptin

EXPERIMENTAL

Film-coated tablet for oral administration Dosage: 20mg/tablet Frequency and duration: 1 tablet/day for 4 weeks

Drug: Teneligliptin

Sitagliptin

ACTIVE COMPARATOR

Film-coated tablet for oral administration Dosage: 100mg/tablet Frequency and duration: 1 tablet/day for 4 weeks

Drug: Sitagliptin

Interventions

Teneligliptin DRUG

Teneligliptin

Sitagliptin DRUG

Sitagliptin

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• (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).
• Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.

You may not qualify if:

• 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)
• 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:

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

HANDOK Inc.

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Sin Gon Kim, MD, Ph.D

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 31, 2015
• Study Start: August 27, 2015
• Primary Completion: September 26, 2016
• Study Completion: September 26, 2016
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

KR (1)