A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 5 mg Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly. |
Drug: Tirzepatide
Administered SC
Other Names:
|
Experimental: 10 mg Tirzepatide 10 mg tirzepatide administered SC once weekly. |
Drug: Tirzepatide
Administered SC
Other Names:
|
Experimental: 15 mg Tirzepatide 15 mg tirzepatide administered SC once weekly. |
Drug: Tirzepatide
Administered SC
Other Names:
|
Active Comparator: Insulin Glargine Insulin glargine administered SC once daily. |
Drug: Insulin Glargine
Administered SC
|
Outcome Measures
Primary Outcome Measures
- Mean Change from Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg) [Baseline, Week 40]
Mean Change from Baseline in HbA1c (10 mg and 15 mg)
Secondary Outcome Measures
- Mean Change from Baseline in HbA1c (5 mg) [Baseline, Week 40]
Mean Change from Baseline in HbA1c (5 mg)
- Mean Change from Baseline in Body Weight [Baseline, Week 40]
Mean Change from Baseline in Body Weight
- Mean Change from Baseline in HbA1c [Baseline, Week 40]
Mean Change from Baseline in HbA1c
- Percentage of Participants Achieving an HbA1c Target Value of <7.0% [Week 40]
Percentage of Participants Achieving an HbA1c Target Value of <7.0%
- Mean Change from Baseline in Fasting Serum Glucose [Baseline, Week 40]
Mean Change from Baseline in Fasting Serum Glucose
- Mean Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values [Baseline, Week 40]
Mean Change from Baseline in 7-Point SMBG Values
- Percentage of Participants who Achieved Weight Loss ≥5% [Week 40]
Percentage of Participants who Achieved Weight Loss ≥5%
- Change from Baseline in Patient-Reported Outcomes as Measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [Baseline, Week 40]
Change from Baseline in Patient-Reported Outcomes as Measured by the DTSQ
- Rate of Documented Symptomatic Hypoglycemic Episodes [Baseline through Week 40]
Rate of Documented Symptomatic Hypoglycemic Episodes
Eligibility Criteria
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)
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HbA1c ≥7.5% to ≤11.0% at screening
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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
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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
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Have acute myocardial infaction (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)
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Paratus Clinical Research Western Sydney | Blacktown | New South Wales | Australia | 2148 |
2 | Paratus Clinical Research Central Coast | Kanwal | New South Wales | Australia | 2259 |
3 | Holdsworth House Medical Practice | Sydney | New South Wales | Australia | 2010 |
4 | Illawarra Shoalhaven Local Health District | Wollongong | New South Wales | Australia | 2500 |
5 | Core Research Group | Milton | Queensland | Australia | 4064 |
6 | Barwon Health - The Geelong Hospital | Geelong | Victoria | Australia | 3220 |
7 | Adelaide Medical Solutions | Woodville South | Australia | 5011 | |
8 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
9 | Huizhou Municipal Central Hospital | Huizhou | Guangdong | China | 516001 |
10 | Cangzhou People's Hospital | Cangzhou | Hebei | China | 061600 |
11 | Hebei Medical University | Hengshui Shi | Hebei | China | 053000 |
12 | The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China | 150001 |
13 | The First Affiliated Hospital of Henan University of Science &Technology | Luoyang | Henan | China | 471003 |
14 | The Second Affiliated Hospital of Zhengzhou University | Zhengzhou Shi | Henan | China | 450014 |
15 | The First People's Hospital of Yueyang | Yueyang | Hunan | China | 414000 |
16 | Bao Tou Central Hospital | Bao Tou | Inner Mongolia | China | 014040 |
17 | Changzhou No.2 People's Hospital | Changzhou | Jiangsu | China | 213003 |
18 | Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China | 210000 |
19 | The First Hospital of Nanjing | Nanjing | Jiangsu | China | 210006 |
20 | Zhongda Hospital Southeast University | Nanjing | Jiangsu | China | 210009 |
21 | The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China | 210011 |
22 | Nanjing Medical University - Nanjing Jiangning Hospital | Nanjing | Jiangsu | China | 211100 |
23 | Suzhou Municipal Hospital | Suzhou | Jiangsu | China | 215002 |
24 | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215066 |
25 | Wuxi People's Hospital | Wuxi | Jiangsu | China | 214023 |
26 | Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China | 212000 |
27 | The Third Hospital of Nanchang | Nanchang | Jiangxi | China | 330009 |
28 | The First Hospital of Jilin University | Changchun | Jilin | China | 130021 |
29 | Dalian University - The Affiliated Zhongshan Hospital | Dalian | Liaoning | China | 116001 |
30 | Shengjing Hospital of China Medical University | Shenyang | Liaoning | China | 110004 |
31 | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China | 710061 |
32 | 1st affiliated Hospital of Shanxi Medical University | Tai Yuan | Shan XI | China | 030001 |
33 | Jinan Central Hospital | Jinan | Shandong | China | 250013 |
34 | Qingdao Central Hospital | Qingdao | Shandong | China | 266042 |
35 | Shanghai 6th people's hospital | Shanghai | Shanghai | China | |
36 | The First Affiliated Hospital of Xi'an Medical University | XI 'an | Shanxi | China | |
37 | West China Hospital Sichuan University | Chengdu | Sichuan | China | 610041 |
38 | Chengdu Fifth People's Hospital | Chengdu | Sichuan | China | 611130 |
39 | Tianjin Medical University General Hospital | Tianjin | Tianjin | China | 300052 |
40 | Chongqing Three Gorges Central Hospital | Wanzhou | Wanzhou | China | 404199 |
41 | Chongqing General Hospital | Chongqing | Yuzhong District | China | 400014 |
42 | Huzhou Central Hospital | Huzhou | Zhejiang | China | 313000 |
43 | Shaoxing People's Hospital | Shaoxing | Zhejiang | China | 312000 |
44 | Beijing Peking Union Medical College Hospital | Beijing | China | 100730 | |
45 | Beijing Pinggu District Hospital | Beijing | China | 101200 | |
46 | Beijing Tsinghua Changgung Hospital | Beijing | China | 102202 | |
47 | Pingxiang People's Hospital | Pingxiang | China | 337000 | |
48 | Shanghai Putuo District Center Hospital | Shanghai | China | 200062 | |
49 | Tianjin People's Hospital | Tianjin | China | 300121 | |
50 | The Fourth People's Hospital of Zigong City | Zigong | China | ||
51 | King Edward Memorial Hospital and Research Center | Mumbai | Maharashtra | India | 400012 |
52 | BSES Municipal General Hsptl | Mumbai | Maharashtra | India | 400058 |
53 | Apollo Gleneagles Hospitals Kolkata | Kolkata | West Bengal | India | 700054 |
54 | Fortis Hospital | Delhi | India | 110088 | |
55 | Kyung Hee University Hospital | Seoul | Gangdong-gu | Korea, Republic of | 02447 |
56 | Seoul National University Bundang Hospital | Seongnam | Geonggi-do | Korea, Republic of | 13620 |
57 | Bucheon St. Mary's Hospital | Bucheon, | Gyeonggi-do | Korea, Republic of | 14647 |
58 | Hanyang University Guri Hospital | Guri-si | Gyeonggido | Korea, Republic of | 11923 |
59 | Yonsei University Wonju Severance Christian Hospital | Gangwon-do | Korea | Korea, Republic of | 220-701 |
60 | Ulsan University Hospital | Ulsan | Korea | Korea, Republic of | 44033 |
61 | Inje University Sanggye Paik Hospital | Seoul | Seoul-teukbyeolsi | Korea, Republic of | 01757 |
62 | Korea University Anam Hospital | Seoul | Seoul-teukbyeolsi | Korea, Republic of | 02841 |
63 | Keimyung University Dongsan Hospital | Daegu | Taegu-Kwangyǒkshi | Korea, Republic of | 41931 |
64 | Korea University Ansan Hospital | Ansan-si | Korea, Republic of | 15355 | |
65 | Severance Hospital | Seoul | Korea, Republic of | 03722 | |
66 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
67 | Hallym University Kangnam Sacred Heart Hospital | Seoul | Korea, Republic of | 07441 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17210
- I8F-MC-GPHO