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 Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes
-
Trial Applicant
NOVO NORDISK PHARMA (TAIWAN) LTD.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 吳婉禎 Division of Endocrinology
- CHIH-YUAN WANG CHIH-YUAN WANG Division of Endocrinology
- Kuo-Chin Huang Division of Family Medicine
- 賴瑩純 Division of Endocrinology
- 盧佳文 Division of Family Medicine
- 張恬君 Division of Endocrinology
- 張皓翔 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Harn-Shen Chen Division of Endocrinology
- 陳涵栩 Division of Endocrinology
- 吳崇暉 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 盧子文 Division of Endocrinology
- Tsung-Hsien Lin Division of Cardiovascular Diseases
- 歐昱侖 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
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
Dosage
2.5, 5, 7.5, 10, 12.5, 15 mg
Endpoints
-Achievement of greater than or equal to (≥) 5% weight reduction [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]
Inclution Criteria
-Male or female
-Age above or equal to 18 years at the time of signing informed consent
-BMI greather than or equal to 27.0 kg/m^2
-Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
-Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
-Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
-HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening
Exclusion Criteria
-Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
-Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, as measured by the central laboratory at screening
-Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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
