Clinical Trials List
2019-04-01 - 2022-12-15
Phase III
Terminated9
A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 versus Titrated Insulin Degludec on Glycemic Control in Patients with Type 2 Diabetes (SURPASS-3)
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly and Company
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chih-Tsueng He Division of Endocrinology
- Anne Chang Division of Endocrinology
- Jiunn-Diann Lin Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 鄭凱比 Division of Endocrinology
- 陳沛吟 Division of Endocrinology
- 杜業豐 Division of Endocrinology
- Hao-Chang Hung Division of Endocrinology
- 林景翰 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
1. Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg).
Secondary Outcome Measures:
1. Change from Baseline in HbA1c.
2. Change from Baseline in Body Weight.
3. Change from Baseline in Fasting Serum Glucose.
4. Percentage of Participants Achieving an HbA1c Target Value of <7%.
5. Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values.
6. Percentage of Participants who Achieved Weight Loss ≥5%.
7. Change from Baseline in Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
8. Rate of Hypoglycemia with Blood Glucose <54 milligram/deciliter (mg/dL) [<3.0 (millimole/liter (mmol/L)] or Severe Hypoglycemia.
Inclution Criteria
2. Have HbA1c between ≥7.0% and ≤10.5%
3. Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
4. Be of stable weight (± 5%) for at least 3 months before screening
5. Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening
Exclusion Criteria
2. Have had chronic or acute pancreatitis any time prior to study entry.
3. Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
4. Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
5. Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range.
6. Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label).
7. Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
8. Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
9. Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months.
10. Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
1420 participants
