Clinical trial NCT05691712: A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
Official title: A Randomized, Phase 3, Double Blind Trial Comparing the Effect of the Addition of Tirzepatide Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Participants With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Disease
Endocrine System Diseases
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Have type 2 diabetes mellitus (T2DM)
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol)
* Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days
* Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have type 1 diabetes mellitus (T1DM)
* Have a history of chronic or acute pancreatitis
* Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
* Have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months
* Have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF) in the past 2 months
* Have a serum calcitonin level of ≥35 ng/L, as determined by central laboratory
* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>3.0 times the upper limit of normal (ULN), as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.

Primary outcomes:
measure: Mean Change from Baseline in HbA1c (Tirzepatide 10 or 15 milligram [mg])
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Mean Change from Baseline in HbA1c (Tirzepatide 5 mg)
timeFrame: Baseline, Week 40
measure: Mean Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percentage of Participants with HbA1c <7.0% (53 millimole/mole [mmol/mol]) and ≤6.5% (48 mmol/mol)
timeFrame: Week 40
measure: Mean Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 40
measure: Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 10 mg or 15 mg]
timeFrame: Week 40
measure: Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 5 mg]
timeFrame: Week 40
measure: Mean Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥5%
timeFrame: Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥10%
timeFrame: Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥15%
timeFrame: Week 40
measure: Percentage Change from Baseline in Daily Mean Insulin Glargine Dose
timeFrame: Baseline, Week 40
measure: Percentage of Participants with HbA1c <7.0%, Without Weight Gain (<0.1 kilogram [kg]) and Without Hypoglycemia, (Blood glucose <3.0 mmol/L <54 milligram/deciliter [mg/dL])
timeFrame: Week 40
measure: Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.0 mmol/L [54 mg/dL])
timeFrame: Week 40
measure: Percentage of Participants with HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.9 mmol/L [70 mg/dL] or Severe hypoglycemia)
timeFrame: Week 40
measure: Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)
timeFrame: Week 40
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu District Hospital
state: Beijing
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Harbin
country: China
facility: The First Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Hospital of Harbin Medical University
state: Heilongjiang
city: LuoyangShi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Yueyang
country: China
facility: The First People's Hospital of Yueyang
state: Hunan
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: WuxiShi
country: China
facility: The Affiliated Jiangyin Hospital of Southeast University Medical College
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: ChengDu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: