Status:
COMPLETED
A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes.
Eligibility Criteria
Inclusion
- Participant must:
- Have been diagnosed with type 2 diabetes mellitus based on the World Health Organization classification before the screening visit.
- Have HbA1c ≥7.0% to \<11.0%, as determined by the central laboratory at screening.
- Have been taking sulfonylureas, biguanides, thiazolidinedione, alpha-glucosidase inhibitor, glinides, or sodium-glucose cotransporter type 2 inhibitor monotherapy for at least 3 months before screening and have been on the following dose for at least 8 weeks before screening.
- Have body mass index (BMI) of ≥23 kilograms per meter squared at screening.
- Be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive 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.
Exclusion
- Participant must not:
- Have type 1 diabetes mellitus.
- Have had chronic or acute pancreatitis any time prior to study entry.
- Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment.
- Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
- Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range.
- Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
- Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
- Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Key Trial Info
Start Date :
March 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2021
Estimated Enrollment :
443 Patients enrolled
Trial Details
Trial ID
NCT03861039
Start Date
March 30 2019
End Date
February 16 2021
Last Update
February 14 2022
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Akaicho Clinic
Chiba, Chiba, Japan, 260 0804
2
Kashiwa hospital
Kashiwa, Chiba, Japan, 277-0825
3
Yuri Ono Clinic
Sapporo, Hokkaido, Japan, 060-0001
4
Manda Hospital
Sapporo, Hokkaido, Japan, 060-0062