Clinical trial NCT04093752: A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
Official title: A Randomized, Phase 3, Open-label Trial Comparing the Effect of Tirzepatide Once Weekly Versus Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes on Metformin With or Without a Sulfonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: T2DM
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-09-18
Enrollment: 917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months
* Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use \[≤14 consecutive days\] for acute conditions)
* HbA1c ≥7.5% to ≤11.0% at screening
* Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
* Body mass Index (BMI) ≥23 kilograms per meter squared

Exclusion Criteria:

* Type 1 diabetes mellitus
* Have history of chronic or acute pancreatitis
* Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
* Have a history of ketoacidosis or hyperosmolar state/coma
* Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility
* Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months

Primary outcomes:
measure: Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Mean Change From Baseline in HbA1c (5 mg)
timeFrame: Baseline, Week 40
measure: Mean Change From Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Percentage of Participants Achieving an HbA1c Target Value of <7.0%
timeFrame: Week 40
measure: Percentage of Participants Achieving an HbA1c Target Value of <5.7%
timeFrame: Week 40
measure: Mean Change From Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 40
measure: Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved Weight Loss ≥5%
timeFrame: Week 40
measure: Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score
timeFrame: Baseline, Week 40
measure: Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia
timeFrame: Baseline through end of safety follow-up (Up To Week 44)
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Wollongong
country: Australia
facility: Illawarra Shoalhaven Local Health District
state: New South Wales
city: Milton
country: Australia
facility: Core Research Group
state: Queensland
city: Geelong
country: Australia
facility: Barwon Health - The Geelong Hospital
state: Victoria
city: Woodville South
country: Australia
facility: Adelaide Medical Solutions
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Cangzhou
country: China
facility: Cangzhou People's Hospital
state: Hebei
city: Hengshui Shi
country: China
facility: Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou Shi
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: Bao Tou
country: China
facility: Bao Tou Central Hospital
state: Inner Mongolia
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: The First Hospital of Nanjing
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: Nanjing
country: China
facility: Nanjing Medical University - Nanjing Jiangning Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
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: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian University - The Affiliated Zhongshan Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Tai Yuan
country: China
facility: 1st affiliated Hospital of Shanxi Medical University
state: Shan XI
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai 6th people's hospital
state: Shanghai
city: XI 'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital 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: Wanzhou
country: China
facility: Chongqing Three Gorges Central Hospital
state: Wanzhou
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Yuzhong District
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Pinggu District Hospital
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Shanghai
country: China
facility: Shanghai Putuo District Center Hospital
city: Tianjin
country: China
facility: Tianjin People's Hospital
city: Zigong
country: China
facility: The Fourth People's Hospital of Zigong City
city: Mumbai
country: India
facility: King Edward Memorial Hospital and Research Center
state: Maharashtra
city: Mumbai
country: India
facility: BSES Municipal General Hsptl
state: Maharashtra
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals Kolkata
state: West Bengal
city: Delhi
country: India
facility: Fortis Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Gangdong-gu
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Geonggi-do
city: Bucheon,
country: Korea, Republic of
facility: Bucheon St. Mary's Hospital
state: Gyeonggi-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggido
city: Gangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Korea
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul-teukbyeolsi
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Taegu-Kwangyǒkshi
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
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: