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Insulin

Tirzepatide for Type 2 Diabetes (SURPASS-6 Trial)

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have HbA1c between ≥7.5% and ≤11%
Have been diagnosed with type 2 diabetes mellitus (T2DM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

SURPASS-6 Trial Summary

This trial will compare the safety and effectiveness of a new diabetes drug, tirzepatide, to the current standard of care, insulin lispro. The trial is for people with type 2 diabetes who are already taking insulin glargine (U100) with or without metformin.

Eligible Conditions
  • Type 2 Diabetes

SURPASS-6 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SURPASS-6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Secondary outcome measures
Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
Change From Baseline in Body Weight
+6 more

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Flatulence
9%
Abortion induced
7%
Amylase increased
7%
Lipase increased
7%
Abdominal pain upper
7%
Gingivitis
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hyperuricaemia
4%
Hepatic function abnormal
3%
Vaginal infection
3%
Dizziness
3%
Uterine polyp
1%
Hiccups
1%
Supraventricular tachycardia
1%
Hand fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
Placebo
15 mg Tirzepatide

SURPASS-6 Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 5 mg TirzepatideExperimental Treatment1 Intervention
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Group II: 15 mg TirzepatideExperimental Treatment1 Intervention
15 mg tirzepatide administered SC once a week.
Group III: 10 mg TirzepatideExperimental Treatment1 Intervention
10 mg tirzepatide administered SC once a week.
Group IV: Insulin LisproActive Control1 Intervention
Insulin lispro 100 units per milliliter (U100) administered SC three times a day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,198,004 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
402,379 Total Patients Enrolled

Frequently Asked Questions

~323 spots leftby Mar 2025