A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04093752
Collaborator
(none)
917
67
4
23.5
13.7
0.6

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

Study Type:
Interventional
Actual Enrollment :
917 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 9, 2019
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Nov 24, 2021

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:
  • LY3298176
  • Experimental: 10 mg Tirzepatide

    10 mg tirzepatide administered SC once weekly.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176
  • Experimental: 15 mg Tirzepatide

    15 mg tirzepatide administered SC once weekly.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176
  • Active Comparator: Insulin Glargine

    Insulin glargine administered SC once daily.

    Drug: Insulin Glargine
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Mean Change from Baseline in HbA1c (5 mg) [Baseline, Week 40]

      Mean Change from Baseline in HbA1c (5 mg)

    2. Mean Change from Baseline in Body Weight [Baseline, Week 40]

      Mean Change from Baseline in Body Weight

    3. Mean Change from Baseline in HbA1c [Baseline, Week 40]

      Mean Change from Baseline in HbA1c

    4. Percentage of Participants Achieving an HbA1c Target Value of <7.0% [Week 40]

      Percentage of Participants Achieving an HbA1c Target Value of <7.0%

    5. Mean Change from Baseline in Fasting Serum Glucose [Baseline, Week 40]

      Mean Change from Baseline in Fasting Serum Glucose

    6. 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

    7. Percentage of Participants who Achieved Weight Loss ≥5% [Week 40]

      Percentage of Participants who Achieved Weight Loss ≥5%

    8. 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

    9. Rate of Documented Symptomatic Hypoglycemic Episodes [Baseline through Week 40]

      Rate of Documented Symptomatic Hypoglycemic Episodes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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)

    • 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.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04093752
    Other Study ID Numbers:
    • 17210
    • I8F-MC-GPHO
    First Posted:
    Sep 18, 2019
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Eli Lilly and Company
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 14, 2021