Clinical Trials List
2024-01-16 - 2026-06-30
Phase III
Recruiting7
ICD-10E11.65
Type 2 diabetes mellitus with hyperglycemia
ICD-10E11.8
Type 2 diabetes mellitus with unspecified complications
ICD-9250.92
Diabetes with unspecified complication, Type II [non-insulin dependent type][NIDDM type][adult-onset type] or unspecified type, uncontrolled
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
-
Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/06/18
Investigators and Locations
Co-Principal Investigator
- 賴瑩純 Division of Endocrinology
- 盧佳文 Division of Family Medicine
- Kuo-Chin Huang Division of Family Medicine
- Tieng-Chun Chang Division of Endocrinology
- 張皓翔 Division of Family Medicine
- 吳婉禎 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳崇暉 Division of Endocrinology
- 陳涵栩 Division of Endocrinology
- Harn-Shen Chen Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Tsung-Hsien Lin Division of Cardiovascular Diseases
- 歐昱侖 Division of Endocrinology
- 盧子文 Division of Endocrinology
- 白哲聲 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Tirzepatide
Dosage Form
Solution for injection
Dosage
2.5, 5, 7.5, 10, 12.5, 15 mg
Endpoints
- Change in HbA1c from baseline (week 0) to end of treatment (week 68)
- Relative change in body weight from baseline (week 0) to end of treatment (week 68)
Inclution Criteria
Male or female (sex at birth).
Age 18 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes ≥ 180 days before screening.
Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Exclusion Criteria
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
Renal impairment with estimated Glomerular Filtration Rate < 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) as determined by central laboratory at screening.
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
The Estimated Number of Participants
-
Taiwan
50 participants
-
Global
1000 participants
