Tirzepatide for Type 2 Diabetes Mellitus

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
GCM Medical Group, PSC - Hato Rey Site, San Juan, Puerto Rico
Type 2 Diabetes Mellitus+2 More
Tirzepatide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Eligible Conditions

  • Type 2 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Type 2 Diabetes Mellitus

Study Objectives

1 Primary · 22 Secondary · Reporting Duration: Week 208

Baseline through Week 104
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental AUC(₀-₂₄₀min)]
Baseline through Week 208
Change from Baseline in Fasting and Post-challenge Glucose [total and incremental (AUC₀-₂₄₀min)]
Baseline, Week 104
Change from Baseline in Fasting Serum Glucose (FSG)
Change from Baseline in Hemoglobin A1c (HbA1c)
Change from Baseline in Weight loss of ≥5%
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Domain
Change from Baseline in β-cell Glucose Sensitivity
Baseline, Week 208
Change from Baseline in FSG
Change from Baseline in HbA1c
Change from Baseline in Insulin Secretion Rate at a Fixed Glucose Concentration
Change from Baseline in Lipids
Change from Baseline in Postprandial Insulin Sensitivity Indices
Change from Baseline in Waist Circumference
Change from Baseline in Weight
Change from Baseline in Weight loss of ≥10%
Change from Baseline in Weight loss of ≥15%
Change from Baseline in Weight loss of ≥5%
Change from Baseline in the IWQOL-Lite-CT - Physical Functioning Domain
Change from Baseline in β-cell glucose sensitivity
Week 208
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia
Percentage of Participants Achieving HbA1c <5.7%
Percentage of Participants Achieving HbA1c <7.0%
Percentage of Participants Achieving HbA1c ≤6.5%

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Type 2 Diabetes Mellitus

Side Effects for

5 mg Tirzepatide
16%Nasopharyngitis
13%Nausea
12%Diarrhoea
7%Dyspepsia
7%Vomiting
7%Decreased appetite
6%Constipation
5%Eructation
5%Arthralgia
5%Back pain
3%Cardiac failure
3%Hypertension
3%Flatulence
3%Lipase increased
2%Hyperglycaemia
1%Asthenia
1%Papillary renal cell carcinoma
1%Atrial fibrillation
1%Coronavirus infection
1%Sleep apnoea syndrome
1%Faecaloma
1%Gastroenteritis
1%Renal neoplasm
0%Pancreatic lesion excision
0%Acute myocardial infarction
0%Orthostatic intolerance
0%Angina pectoris
0%Myocardial infarction
0%Uterine cancer
0%Urinary tract infection
0%Spinal compression fracture
0%Bladder disorder
0%Pulmonary embolism
0%Intestinal anastomosis complication
0%Humerus fracture
0%Transitional cell carcinoma
0%Hypoglycaemia
0%Coronary artery disease
0%Impaired healing
0%Tachycardia
0%Spinal stenosis
0%Synovial cyst
0%Transient ischaemic attack
0%Deafness unilateral
0%Hip fracture
0%Aortic stenosis
0%Peripheral arterial occlusive disease
0%Hypoglycaemic unconsciousness
0%Respiratory failure
0%Cardiac ablation
0%Abdominal hernia
0%Cellulitis
0%Postoperative wound infection
0%Pancreatic disorder
0%Syncope
0%Covid-19 pneumonia
0%Pyelonephritis
0%Anxiety
0%Calculus urinary
0%Chronic obstructive pulmonary disease
0%Dyspnoea
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT04039503) in the 5 mg Tirzepatide ARM group. Side effects include: Nasopharyngitis with 16%, Nausea with 13%, Diarrhoea with 12%, Dyspepsia with 7%, Vomiting with 7%.

Trial Design

2 Treatment Groups

Intensified Conventional Care Dose
1 of 2
Tirzepatide
1 of 2
Active Control
Experimental Treatment

780 Total Participants · 2 Treatment Groups

Primary Treatment: Tirzepatide · No Placebo Group · Phase 4

Tirzepatide
Drug
Experimental Group · 1 Intervention: Tirzepatide · Intervention Types: Drug
Intensified Conventional Care Dose
Drug
ActiveComparator Group · 1 Intervention: Antihyperglycemic medication · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 208
Closest Location: Lucas Research, Inc · Morehead City, NC
N/AFirst Recorded Clinical Trial
2 TrialsResearching Type 2 Diabetes Mellitus
0 CompletedClinical Trials

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,428 Previous Clinical Trials
3,117,464 Total Patients Enrolled
127 Trials studying Type 2 Diabetes Mellitus
88,083 Patients Enrolled for Type 2 Diabetes Mellitus
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)Study DirectorEli Lilly and Company
1,231 Previous Clinical Trials
364,079 Total Patients Enrolled
51 Trials studying Type 2 Diabetes Mellitus
37,450 Patients Enrolled for Type 2 Diabetes Mellitus

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have HbA1c between 7% and 9.5% as determined by the central laboratory.
You have been on a stable treatment of metformin for at least 90 days preceding baseline.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.