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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04093752
Registration number
NCT04093752
Ethics application status
Date submitted
17/09/2019
Date registered
18/09/2019
Date last updated
6/01/2023
Titles & IDs
Public title
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)
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Scientific 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
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Secondary ID [1]
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I8F-MC-GPHO
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Secondary ID [2]
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17210
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide
Treatment: Drugs - Insulin Glargine
Experimental: 5 mg Tirzepatide - Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).
Experimental: 10 mg Tirzepatide - Participants received 10 mg tirzepatide administered SC QW.
Experimental: 15 mg Tirzepatide - Participants received 15 mg tirzepatide administered SC QW.
Active Comparator: Insulin Glargine - Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm.
Treatment: Drugs: Tirzepatide
Administered SC
Treatment: Drugs: Insulin Glargine
Administered SC
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)
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Assessment method [1]
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HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with covariates Baseline + Country + Baseline Oral Antihyperglycemic Medication (OAM) Use (Metformin (Met), Met plus Sulfonylurea (SU)) + Treatment + Time + Treatment*Time (Type III sum of squares).
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Timepoint [1]
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Baseline, Week 40
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Secondary outcome [1]
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Mean Change From Baseline in HbA1c (5 mg)
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Assessment method [1]
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HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model with covariates Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Treatment + Time + Treatment*Time (Type III sum of squares).
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Timepoint [1]
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Baseline, Week 40
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Secondary outcome [2]
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Mean Change From Baseline in Body Weight
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Assessment method [2]
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LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
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Timepoint [2]
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Baseline, Week 40
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Secondary outcome [3]
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Percentage of Participants Achieving an HbA1c Target Value of <7.0%
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Assessment method [3]
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HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Imputed data includes observed value and imputed value if endpoint measure is missing.
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Timepoint [3]
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Week 40
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Secondary outcome [4]
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Percentage of Participants Achieving an HbA1c Target Value of <5.7%
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Assessment method [4]
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HbA1c is the glycosylated fraction of hemoglobin A. Imputed data includes observed value and imputed value if endpoint measure is missing.
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Timepoint [4]
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Week 40
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Secondary outcome [5]
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Mean Change From Baseline in Fasting Serum Glucose
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Assessment method [5]
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Fasting serum glucose (FSG) is a test to determine sugar levels in serum sample after an overnight fast. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
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Timepoint [5]
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Baseline, Week 40
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Secondary outcome [6]
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Mean Change in Daily Glucose Average From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values
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Assessment method [6]
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The SMBG data was collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post-meal, Midday Premeal, Midday 2-hour Post-meal, Evening Premeal, Evening 2-hour Post-meal and Bedtime. LS mean was determined by MMRM model with Baseline + Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment + Time + Treatment*Time (Type III sum of squares) as covariates.
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Timepoint [6]
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Baseline, Week 40
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Secondary outcome [7]
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Percentage of Participants Who Achieved Weight Loss =5%
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Assessment method [7]
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Imputed data includes observed value and imputed value if endpoint measure is missing.
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Timepoint [7]
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Week 40
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Secondary outcome [8]
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Diabetes Treatment Satisfaction as Measured by the Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc) Hyperglycemia, Hypoglycemia and Treatment Satisfaction Score
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Assessment method [8]
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DTSQc, an 8-item questionnaire, assesses relative change in treatment satisfaction perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia from baseline to week 40 or early termination. The treatment satisfaction score ranges from -18 to 18 where the higher the score the greater the improvement in satisfaction with treatment. The lower the score the greater the deterioration in satisfaction with treatment. The hyperglycemia and hypoglycemia scores range from -3 to 3 where negative scores indicate fewer problems with blood glucose levels and positive scores indicate more problems than before. LS mean was determined by ANCOVA model for endpoint measures with Baseline + Country + Baseline HbA1c Group (<=8.5%, >8.5%) + Baseline OAM Use (Met, Met plus SU) + Treatment (Type III sum of squares) as covariates.
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Timepoint [8]
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Baseline, Week 40
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Secondary outcome [9]
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Rate of Hypoglycemia With Blood Glucose < 54 mg/dL or Severe Hypoglycemia
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Assessment method [9]
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The hypoglycemia events were defined by participant reported events with blood glucose < 54 mg/dL [<3.0 Millimole per Liter (mmol/L)] or severe hypoglycemia. Severe hypoglycemia is defined as an episode with severe cognitive impairment requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. The rate of post-baseline hypoglycemia was estimated by negative binomial model: Number of episodes = Country + Baseline OAM Use (Met, Met plus SU) + Baseline HbA1c Group (<= 8.5%, >8.5%) + Treatment, with log (exposure in days/365.25) as an offset variable.
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Timepoint [9]
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Baseline through end of safety follow-up (Up To Week 44)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/12/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/11/2021
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Sample size
Target
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Accrual to date
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Final
917
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Paratus Clinical Research Western Sydney - Blacktown
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Recruitment hospital [2]
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Paratus Clinical Research Central Coast - Kanwal
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Recruitment hospital [3]
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Holdsworth House Medical Practice - Sydney
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Recruitment hospital [4]
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Illawarra Shoalhaven Local Health District - Wollongong
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Recruitment hospital [5]
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Core Research Group - Milton
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Recruitment hospital [6]
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Barwon Health - The Geelong Hospital - Geelong
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Recruitment hospital [7]
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Adelaide Medical Solutions - Woodville South
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2259 - Kanwal
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Recruitment postcode(s) [3]
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2010 - Sydney
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Recruitment postcode(s) [4]
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2500 - Wollongong
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Recruitment postcode(s) [5]
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4064 - Milton
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Recruitment postcode(s) [6]
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3220 - Geelong
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Recruitment postcode(s) [7]
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5011 - Woodville South
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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China
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State/province [2]
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Guangdong
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China
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State/province [3]
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Hebei
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Country [4]
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China
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State/province [4]
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Heilongjiang
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Country [5]
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China
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State/province [5]
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Henan
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Country [6]
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China
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State/province [6]
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Hunan
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Country [7]
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China
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State/province [7]
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Inner Mongolia
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Country [8]
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China
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State/province [8]
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Jiangsu
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Country [9]
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China
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State/province [9]
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Jiangxi
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Country [10]
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China
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State/province [10]
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Jilin
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Country [11]
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China
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State/province [11]
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Liaoning
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China
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State/province [12]
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Shaanxi
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Country [13]
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China
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State/province [13]
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Shan XI
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China
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State/province [14]
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Shandong
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China
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State/province [15]
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Shanghai
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China
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Shanxi
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China
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Sichuan
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China
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Tianjin
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China
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Wanzhou
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China
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Yuzhong District
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China
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Zhejiang
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China
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Pingxiang
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China
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Zigong
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India
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Maharashtra
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India
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West Bengal
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India
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State/province [26]
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Delhi
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Country [27]
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Korea, Republic of
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Gangdong-gu
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Korea, Republic of
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Geonggi-do
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Korea
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Korea, Republic of
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Seoul-teukbyeolsi
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Korea, Republic of
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Taegu-Kwangyokshi
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Korea, Republic of
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Ansan-si
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Korea, Republic of
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State/province [35]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04093752
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04093752
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